boson rapid sars-cov-2 antigen test (clinical)
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Eleganti AB Customer Support
Folkungagatan 99 Tel: 08-12204992 116 30 Stockholm, Sweden Email: [email protected] Org.nr: 556686-1158 Website: www.eleganti.se Momreg.nr: SE556686115801
BOSON Rapid SARS-CoV-2 Antigen Test (clinical)
Product Description• BOSON clinical test is used for
rapid qualitative detection of SARS-CoV-2 virus antigen in anterior nasal swabs within 7 days of symptom onset.
• Detect the antigen of the virus, indicating the active viral infection.
• Instant results in 15-20 minutes.• Easy to use, no equipment required.• Non-invasive sampling (nasal swab)• Helps with COVID19 early
detection.
Other details:• Sensitivity: 96.77%• Room temperature storage (2-30℃)
Packaging:20 tests/packEach test incl.1 rapid SARS-CoV-2 Antigen test card (sealed foil pouch), 1 sterilized swab, 1 extraction tube, 1 sample extraction buffer, instruction for use, tube holder on back of box
Specifications
Art.nr: CVT0014
Model: 1N40C5-6
Material: Vitro diagnostic reagent
ISO Standard:
EN 13612:2002EN 62366-1:2015
EN ISO13485:2016EN ISO 23640:2015EN ISO 14971:2012
EN ISO 15223-1:2016EN ISO 18113-1/4:2011
Standards: CE approved, EU labs tested, clinical report available
Certification: CE(NB:0123), 98/79/EC IVDD, TUV EC certificate, Declaration of Conformity
EC CertificateEC Design-Examination CertificateDirective 98/79/EC on In Vitro Diagnostic Medical Devices (IVDD), Annex III (6)(Devices for self-testing)No. V9 061317 0006 Rev. 00
Page 1 of 1TÜV SÜD Product Service GmbH is Notified Body with identification no. 0123
TÜV SÜD Product Service GmbH • Certification Body • Ridlerstraße 65 • 80339 Munich • Germany
Manufacturer: Xiamen Boson Biotech Co., Ltd.90-94 Tianfeng RoadJimei North Industrial Park361021 Xiamen, FujianPEOPLE'S REPUBLIC OF CHINA
Product: In Vitro diagnostic devices for self testing
Model(s): Rapid SARS-CoV-2 Antigen Test Card
Parameters: Model Name: Model No.:
Rapid SARS-CoV-2 Antigen Test Card REF 1N40C5-2 Rapid SARS-CoV-2 Antigen Test Card REF 1N40C5-4Rapid SARS-CoV-2 Antigen Test Card REF 1N40C5-6
The Certification Body of TÜV SÜD Product Service GmbH declares that a design examination has been carried out on the respective devices in accordance with IVDD Annex III (6). The design of the devices conforms to the requirements of this Directive. All applicable requirements of the testing and certification regulation of TÜV SÜD Group have to be complied with. For details and certificate validity see: www.tuvsud.com/ps-cert?q=cert:V9 061317 0006 Rev. 00
Report No.: 713210321
Valid from: 2021-04-01Valid until: 2022-05-26
Date, 2021-04-01
Christoph DicksHead of Certification/Notified Body
Declaration of Conformity
Manufacturer Xiamen Boson Biotech CO,. Ltd.90-94 Tianfeng Road, Jimei North Industrial Park,Xiamen, Fujian 361021, P. R. China.
Device/s Rapid SARS-CoV-2 Antigen Test Card
EuropeanRepresentative
Lotus NL B.V.Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands.
Classification Others
Confirmative Assessment Route 98/79/EC IVDD Annex III
We, Xiamen Boson Biotech Co., Ltd. declare that the above mentiond devices conforms to the relevant provisions of the EC Council Directive 98/79 and is in accordance with the Annex III, ISO 13485:2016 Quality Management System, as implemented by the European Union’s Medical Devices Regulations and the Federal and Local Authorities.
Place, Date of Issue Xiamen, 2020-08-04
Signature(Signed By Boson Representative)
Name: Changgong ZhangTitle: General Manager
CIBG Ministry of Public Health,
Welfare and Sport
Page 1 of 2
Lotus NL B.V.
Koningin Julianaplein 10,
1e Verd, 2595AA,
The Hague, Netherlands.
Date: 13 August 2020
Subject: Notification in vitro diagnostics
Dear Mr. Wei,
On August 9, 2020 we received your notification according to article 4 in-vitro diagnostics, under the name Xiamen Boson Biotech Co., Ltd., with the European Representative Lotus NL B.V., put out into the European market the below mentioned products.
This product has been registered as an in-vitro diagnostic with the number:
D-Dimer Test, H.Pylori Antigen Test, H.Pylori Antibody Test, Rotavirus Antigen Test, V.Cholerae O1/O139 Duo Test, Salmonella typhi Antigen Test, Salmonella typhi IgG/IgM Combo Test, Rickettsia IgG/IgM Combo Test, Tuberculosis Test,Cardiac Panel Test
(geen merknaam) (NL-CA002-2020-52870) Rapid SARS-CoV-2 Antigen Test Card, Syphilis Antibody Test, Malaria Antigen Test, Dengue IgG/IgM Combo Test, Dengue NS1 Antigen and IgG/IgM Duo Panel Test, C-reactive Protein Test,HCG Pregnancy Test, LH Test,Troponin I Test,Myoglobin Test,CK-MB Test
(geen merknaam) (NL-CA002-2020-52869)
Herewith you will have fulfilled your obligations under Article 4.
For future correspondence concerning the above-mentioned product we kindly request you to use this number. No rights can be derived from this number; its sole purpose is to simplify the administrative side of the notification.
The registration of the above product as a medical device APPLICABLE PRODUCTS according to the requirements with the European Directive 98/79/EC is subject to possible revisions of the European law concerning the classification of medical devices and to advanced scientific understanding (see art. 10 of the European Directive 98/79/EC).
Notification of medical devices implies that Xiamen Boson Biotech Co., Ltd., has applied the CE conformity marking on the corresponding product before bringing it out into the
CIBG Ministry of Public Health,
Welfare and Sport
Page 2 of 2
EU-member state market. Consequently, Lotus NL B.V. guarantees that the medical device meets the essential requirements as stated in the Guideline and the Decision.
To complete this, we would like to point out that a medical device must comply with the demands of the Decision Medical Devices. This Decision is based upon in-vitro diagnostics 98/79/EC and the legal text requirements for The Netherlands. We especially would like to point out the language requirement as required in The Netherlands, the requirements for keeping at our disposal the technical documentation and the obligation to having a Post Marketing Surveillance and vigilance system.
Finally, I note that with your notification - the administrative notification as manufacturer - and this letter there is no judgment on an opinion on the status or classification of the in vitro diagnostic product for the purposes of this Law and regulations. Where appropriate, IGZ, responsible for monitoring the compliance by or pursuant to the law, can take a position on the status of a product which, according to settled case law ultimately for the national court to determine whether a product falls within the definition of an in vitro diagnostic product.
The Minister for Health and Sport,
on behalf of this,
Head of Pharmaceuticals
Sir. M.J. van de Velde
ssIzI
~ft' CIBG Ministerie van Volksgezondheid, Welzijn en Sport
> Retouradres Postbus 16114 2500 BC Den Haag
Lotus NL B.V. T.a.v. de heer X. Wei Koningin Julianaplein 10 2595 AA 's-Gravenhage
Datum: 13 augustus 2020 Betreft: aanmelding In-vitro diagnostica
Geachte heer Wei,
Op 9 augustus 2020 ontving ik uw notificatie krachtens artikel 4, eerste lid van het Nederlandse Besluit in-vitro diagnostica (BIVD) om onder de bedrijfsnaam Xiamen Boson Biotech Co., Ltd. met Europees gemachtigde Lotus NL B.V. onderstaande producten als in-vitro diagnostica op de Europese markt te brengen.
De producten staan geregistreerd als in-vitro diagnostica onder nummer:
D-Dimer Test, H.Pylori Antigen Test, H.Pylori Antibody Test, Rotavirus Antigen Test, V.Cholerae 01/0139 Duo Test, Salmonella typhi Antigen Test, Salmonella typhi IgG/IgM Combo Test, Rickettsia IgG/IgM Combo Test, Tuberculosis Test,Cardiac Panel Test
(geen merknaam) (NL-CA002-2020-52870) Rapid SARS-CoV-2 Antigen Test Card, Syphilis Antibody Test, Malaria Antigen Test, Dengue IgG/IgM Combo Test, Dengue NS1 Antigen and IgG/IgM Duo Panel Test, C-reactive Protein Test,HCG Pregnancy Test, LH Test,Troponin I Test,Myoglobin Test,CK-MB Test
(geen merknaam) (NL-CA002-2020-52869)
Farmatec
Bezoekadres: Hoftoren Rijnstraat 50 2515 XP Den Haag
T 070 340 6161
htto://hulorniddelenfarmatec.ni
Inlichtingen bij: M. Schmitz - Konte
medische_huipmiddelen© minvws.n1
Ons kenmerk: CIBG-20203899
Bijlagen
Uw aanvraag 9 augustus 2020
Correspondentie uitsluitend richten aan het retouradres met vermelding van de datum en het kenmerk van deze brief.
Hiermee heeft u voldaan aan uw verplichting op grond van artikel 4, BIVD.
In alle verdere correspondentie betreffende bovenvermelde producten verzoek ik u deze nummers te vermelden. Aan deze nummers kunnen geen verdere rechten ontleend worden, ze dienen alleen om de notificatie administratief te vergemakkelijken.
De registratie van in-vitro diagnostica als medisch hulpmiddel op grond van de Classificatiecriteria (Bijlage II) bij Richtlijn 98/79/EG betreffende medische hulpmiddelen voor in-vitro diagnostiek is onderhevig aan mogelijke revisies van Europese regelgeving inzake de classificatie van medische hulpmiddelen en aan voortschrijdend wetenschappelijk inzicht (zie artikel artikel 10, eerste lid van Richtlijn 98/79/EG).
Pagina 1 van 2
Notificatie van in-vitro diagnostische medische hulpmiddelen impliceert dat de fabrikant, Xiamen Boson Biotech Co., Ltd. de CE-conformiteitsmarkering heeft aangebracht op de desbetreffende producten alvorens deze in een EU-lidstaat in de handel te brengen. Zodoende garandeert Lotus NL B.V. dat de in-vitro diagnostica voldoen aan de essentiële eisen zoals opgenomen in bijlage I bij Richtlijn 98/79/EG (en in het daarmee corresponderende onderdeel 1 bij het besluit)
Volledigheidshalve wijzen wij u erop dat een in-vitro diagnosticum moet voldoen aan de eisen uit het BIVD. Het BIVD is gebaseerd op Richtlijn voor in-vitro diagnostiek, 98/79/EG. Met name wijzen wij u op de Nederlandse-taaleis zoals deze in Nederland geldt, de eisen voor het ter beschikking houden van de technische documentatie en de plicht tot het hebben van een Post Marketing Surveillance- en vigilantiesysteem.
Tot slot merk ik op dat met uw notificatie - de administratieve notificatie als fabrikant - en deze brief geen sprake is van een oordeel over de status of kwalificatie van uw product: notificering betekent niet dat daadwerkelijk sprake is van een in-vitro diagnosticum in de zin van de onderhavige wet- en regelgeving. In voorkomende gevallen kan de Inspectie Gezondheidszorg en Jeugd (IGJ), belast met het toezicht op de naleving van het bij of krachtens de wet bepaalde, een standpunt innemen over de status van een product, waarbij het volgens vaste jurisprudentie uiteindelijk aan de nationale rechter is om te bepalen of een product onder de definitie van in-vitro diagnosticum valt.
De Minister voor Medische Zorg en Sport, namens deze,
Afdelingshoofd Farmatec
Dr. M.J. van de Velde
Pagina 2 van 2
Page 11
Authorization Acknowledgement from China Chamber of Commerce for Import & Export of
Medicines & Health Products 中国医药保健品进出口商会白名单
Source 网址: http://www.cccmhpie.org.cn/Pub/6325/178081.shtml
取得国外标准认证或注册的医疗物资企业清单
Name List of Medical Devices and Supplies Companies with Certification/Authorization from other Countries
序号 生产企业 统一社会信用代码 国外注册认证
情况 省份 产品型号
No. Company Uniform Social Credit
Code
Status of
Certification /
Authorization
in Other
Countries
Province Product Model
60
厦门市波
生生物技
术有限公
司
Xiamen
Boson
Biotech
Co., Ltd
91350200705468594R CE 福建
2019-nCoV IgG/IgM Combo Test Card
Rapid SARS-CoV-2 Antigen Test Card
Rapid SARS-CoV-2/Influenza A+B
Antigen Duo Test Card
Anti-SARS-CoV-2 S Protein Antibody
Quantitative Test
SARS-CoV-2 Neutralizing Antibody Test
Card
SARS-CoV-2 Neutralizing Antibody
Quantitative Test
SARS-CoV-2 Antigen Saliva Test Card
Anti-SARS-CoV-2 S Protein Antibody
Test Card
Page 12
Registration Completed in Individual Countries 部分国家注册完成情况
¾ Germany 德国 Source 网址: https://www.bfarm.de/DE/Medizinprodukte/Antigentests/_node.html
¾ France 法国 Source 网址: https://covid-19.sante.gouv.fr/tests
Page 13
¾ The Netherlands 荷兰 Source 网址:
https://www.rijksoverheid.nl/documenten/publicaties/2021/03/10/ontheffingen-ant
igeentesten
Page 14
¾ Italy 意大利 Source 网址:
http://www.salute.gov.it/interrogazioneDispositivi/RicercaDispositiviServlet?action=
ACTION_MASCHERA
Page 15
¾ Belgium 比利时 Source 网址:
https://www.fagg.be/sites/default/files/content/Belgian%20validation_CE_autotest.xl
sx
Lijst van SARS-CoV-2 antigen zelftesten - verkoop in de apotheek
Liste des autotests antigéniques du SARS-CoV-2 - vente en pharmacie
List of SARS-CoV-2 antigen self-tests - sold in pharmacies
versie/version 13.04.2021
Merk op dat de verkoop van deze zelftesten aan particulieren momenteel enkel toegelaten is in de
apotheek. De apotheker informeert bovendien de koper over het gebruik van de zelftest en wijst erop
dat een arts moet gecontacteerd worden in geval van een positief resultaat.
A noter que la vente de ces autotests à des particuliers n'est actuellement autorisée qu'en pharmacie.
Le pharmacien informe également l'acheteur de l'utilisation de l'autotest et rappelle qu'un médecin
doit être contacté en cas de résultat positif.
Note that the sale of these self-tests to private individuals is currently only allowed in pharmacies. The
pharmacist also informs the purchaser about the use of the self-test and points out that a doctor
should be contacted in case of a positive result.
Fabrikant/
Fabricant/
Manufacturer
gemachtigde/représent
ant autorisé/authorised
representative
Naam van de
test/Nom du
test/Name of the
test
Referentie/
Référence/
Reference
Datum
certificaat
Date du
certificat
Certificate
date
Xiamen Boson
Biotech Co., Ltd.
(CH)
Lotus NL B.V. (NL) Rapid SARS-CoV-2
Antigen Test Card 1N40C5-2 1/04/2021
Page 16
¾ Luxemburg 卢森堡 Source 网址: http://legilux.public.lu/eli/etat/leg/amin/2021/04/06/a270/jo
Page 17
¾ Greece 希腊 Source 网址:
https://www.eof.gr/web/guest/home?p_p_id=62_INSTANCE_0eNL&p_p_lifecycle=0&p
_p_state=maximized&p_p_mode=view&_62_INSTANCE_0eNL_struts_action=%2Fjourna
l_articles%2Fview&_62_INSTANCE_0eNL_groupId=12225&_62_INSTANCE_0eNL_articl
eId=6116409&_62_INSTANCE_0eNL_version=1.0
Paul-Ehrlich-Institut Paul-Ehrlich-Str. 51-59 63225 Langen, Germany www.pei.de
17.12.2020
Comparative evaluation of the sensitivities of SARS-CoV-2 antigen rapid tests Aim Comparison of different antigen rapid tests with using identical sample material Material Pools from nasopharyngeal and oropharyngeal swabs. Dry swabs were included in PBS; moist swabs were already included in the transport media of various compositions. Pools are random mixtures obtained from up to 10 samples of comparable CT values diluted 1:10 in negative samples in PBS. The CT values of a pool were determined by means of different PCR assays, and the putative number of RNA copies calculated with the aid of the INSTAND standards. In the case of the PCRs used, a CT value of 25 corresponds to around 106 RNA copies/mL. 18 samples each were analysed with CT<25, 23 samples with CT between 25 and 30, and 9 samples with CT>30. The replication of the virus in cell culture was determined as a possible correlate for infectiousness as another characteristic of the samples. Method The pools were aliquoted, frozen, shipped, and thawed for evaluation of the tests. For each test, 50 µL of the pool were analysed using the components of the test provided, e.g. swabs. Laboratories participating in the comparative evaluation included the Robert Koch-Institut, the Paul-Ehrlich-Institut, the reference laboratory for coronaviruses (Charité), and the Institute for Microbiology of the German Army (Bundeswehr). Summary This comparative evaluation of a large number of SARS-CoV-2 rapid antigen tests (point of care tests; POCT) of different designs and manufacturers with the same sample set allows an overview of the current state of art regarding sensitivity. The results do not allow any conclusions regarding specificity of the tests. Those POCTs which have up to now been included in the evaluation and have been assessed as reflecting the current state of the art are listed in the table below. Other tests, which were assessed as not reflecting the state of the art were deleted from the list of the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM). This comparative evaluation is constantly continued, and the table is amended accordingly. You should be aware that this comparative evaluation can only cover a random sample of the SARS-CoV-2 rapid antigen tests listed by the BfArM, thus eligible for refunding, and that many other products could not (yet) be taken into account, despite the interests on the part of the manufacturers/distributors. Contact Email: sarscov2ivd@pei
Page 2/2
Last updated: 17.12.2020Overview of SARS-CoV-2 Antigen Rapid Tests Assessed as Reflecting the Current State of the Art
Name of Test Manufacturer or Distributor Panbio™COVID-19 Ag Rapid Test Device (NASOPHARYNGEAL)
Abbott Rapid Diagnostics Jena GmbH
RIDA®QUICK SARS-CoV-2 Antigen R-Biopharm AGSARS-CoV-2 Rapid Antigen Test SD BIOSENSOR (Roche Diagnostics
GmbH) NADAL® COVID-19 Ag Schnelltest nal von minden gmbh
STANDARD™ F COVID-19 Ag FIA SD BIOSENSOR STANDARD™ Q COVID-19 Ag Test SD BIOSENSOR BIOSYNEX COVID-19 Ag BSS BIOSYNEX SWISS SA MEDsan® SARS-CoV-2 Antigen Rapid Test MEDsan GmbH
TestNOW® - COVID-19 Antigen Affimedix
NowCheck® COVID-19 Ag Test BIONOTE
Coronavirus Ag Rapid Test Cassette (Swab) Zhejiang Orient Gene Biotech Co.,Ltd Sofia SARS Antigen FIA Quidel Corporation COVID-19 Ag Test Kit Guangdong Wesail Biotech Co., Ltd. CLINITEST® Rapid COVID-19 Antigen Test Siemens Healthineers
ESPLINE® SARS-CoV-2 Fujirebio Inc. (Mast Diagnostica GmbH) BD Veritor™ System for Rapid Detection of SARS-CoV-2
Becton Dickinson
GenBody COVID-19 Ag IVC Pragen Healthcare
LumiraDx SARS-CoV-2 Ag Test LumiraDX Exdia COVID-19-Ag-Test Precision Biosensor Inc. (Axon Lab AG) SARS-CoV-2 Ag Rapid Test (FIA) Wantai (Beijing Wantai Biological Pharmacy
Enterprise Co., Ltd.) SARS-CoV-2 Antigen Schnelltest Xiamen Boson Biotech Co., Ltd
(Medicovid-AG; technomed GmbH; Löwe Medizintechnik)
COVID-19 Antigen Schnelltest (Colloidal Gold) Joinstar Biomedical Technology Co., Ltd (CIV care impuls Vertrieb)
mö-screen Corona Antigen Test Mölab GmbH
Rapid SARS-CoV-2 Antigen Test Card MP Biomedicals Germany GmbH Novel Coronavirus (COVID-19) Antigen Test Kit Hangzhou Laihe Biotech Co., Ltd. (Lissner
Qi GmbH)
RAPID SARS-COV-2 ANTIGEN TEST CARD
FOR THE QUALITATIVE ASSESSMENT OF SARS-COV-2 VIRUS ANTIGEN IN NASAL SWAB, NASOPHARYNGEAL SWAB OR OROPHARYNGEAL SWAB SPECIMENS
Catalog Number: 1N40C5 For In Vitro Diagnostic Use Only
INTENDED USE
Rapid SARS-CoV-2 Antigen Test Card is an immunochromatography based one step in vitro test. It is designed for the rapid qualitative determination of SARS-CoV-2 virus antigen in nasal swabs, nasopharyngeal swabs or oropharyngeal swabs from individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset. Rapid SARS-CoV-2 Antigen Test Card can not be used as the basis to diagnose or exclude SARS-CoV-2 infection. Rapid SARS-CoV-2 Antigen Test Card detects the SARS-CoV-2 nucleocapsid protein (N protein). Theoretically, genetic SARS-CoV-2 variants with non-nucleocapsid protein mutations do not affect the product performance. SUMMARY
The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection, asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases. PRINCIPLE
Rapid SARS-CoV-2 Antigen Test Card is an immunochromatographic lateral flow device that employs the principle of double antibody sandwich method. Colloidal gold conjugated anti-SARS-CoV-2 antibodies are dry-immobilized on the test device. When the specimen is added, it migrates by capillary diffusion through the strip to re-hydrate the gold conjugate complexes. If present at or above the limit of detection, SARS-CoV-2 viral antigens will react with the gold conjugate complexes to form particles, which will continue to migrate along the strip until the Test Zone (T) where they are captured by the immobilized anti-SARS-CoV-2 antibodies to form a visible red line. If there are no SARS-CoV-2 viral antigens in the specimen, no red line will appear in the Test Zone (T). The gold conjugate complexes will continue to migrate alone until being captured by immobilized antibody in the Control Zone (C) to form a red line, which indicates the validity of the test. MATERIALS PROVIDED
1. Rapid SARS-CoV-2 Antigen Test Card 2. Sterilized swab 3. Extraction tube 4. Sample extraction buffer 5. Tube Stand 6. Instructions for use MATERIALS REQUIRED BUT NOT SUPPLIED
Clock or timer, specimen collection container, biohazard waste container. personal protection equipment.
STORAGE
1. Store the test device at 4 to 30oC in the original sealed pouch. Do Not Freeze. 2. Kit contents are stable until the expiration date printed on the outer box based on the proper storage conditions. 3. The test device should remain in its original sealed pouch until ready for use. After opening, the test device should be used immediately. Do not reuse the device. PRECAUTIONS
1. For professional in vitro diagnostic use only. 2. The product is strictly for medical professional use only and not intended for personal use. 3. Do not use the product beyond the expiration date. 4. Do not use the product if the pouch is damaged or the seal is broken. 5. Handle all specimens as potentially infectious. 6. Follow standard Lab procedure and biosafety guidelines for handling and disposal of potentially infectious material. 7. Inadequate or inappropriate specimen collection, storage, and transport may yield inaccurate test results. 8. Specific training or guidance is recommended if operators are not experienced with specimen collection and handling procedures. Wear protective clothing such as laboratory coats, disposable gloves, and eye protection when specimens are collected and evaluated. Pathogenic microorganisms, including hepatitis viruses and Human Immunodeficiency Virus, may be present in clinical specimens. Standard precautions and institutional guidelines should always be followed in handling, storing, and disposing of all specimens and all items contaminated with blood or other body fluids. SPECIMEN COLLECTION
Proper specimen collection, storage, and transport are critical to the performance of this test. Specimens should be tested as soon as possible after collection. The training in specimen collection is highly recommended because of the importance of specimen quality. For optimal test performance, use the swabs supplied in the kit.
Nasopharyngeal swab specimens:
1. Carefully insert the swab into the nostril of the patient, reaching the surface of posterior nasopharynx that presents the most secretion. 2. Swab over the surface of the posterior nasopharynx. Rotate the swab several times. 3. Withdraw the swab from the nasal cavity.
Oropharyngeal swab specimens:
Let the patient's head tilt slightly, mouth open, and make "ah" sounds, exposing the pharyngeal tonsils on both sides. Hold the swab and wipe the pharyngeal tonsils on both sides of the patient with moderate force back and forth for at least 3 times. Avoid touching the tongue, teeth and gums.
Nasal swab specimens:
1. Carefully insert the swab into one nostril of the patient. The swab tip should be inserted no less than 2.5 cm (1 inch) from the edge of the nostril. 2. Roll the swab 3-4 times along the mucosa inside the nostril to ensure that both mucus and cells are collected. Leave the swab in the nostril for several seconds. 3. Using the same swab, repeat this process for the other nostril to ensure that an adequate sample is collected from both nasal cavities. 4. Withdraw the swab from the nasal cavity.
SPECIMEN PREPARATION
1. Add 8 drops (about 0.25 mL) of extraction buffer into the extraction tube. 2. Place the swab with specimen into the extraction tube. Roll the swab three to five (3-5) times. Leave the swab in the extraction
buffer for 1 minute. 3. Pinch the extraction tube with fingers and remove the solution from the swab as much as possible. Dispose of the used swab in accordance with your biohazard waste disposal protocol. 4. Install the nozzle cap onto the sample extraction tube tightly. Use extraction solution as test specimen.
PROCEDURE
1. Bring the kit components to room temperature before testing. 2. Open the pouch and remove the card. Once opened, the test card must be used immediately. Label the test card with patient identity. 3. Invert the extraction tube and add 3 drops (about 75 μL) of test specimen into the specimen well (S) by gently squeezing the extraction tube. The formation of air bubbles in the specimen well (S) must be avoided. 4. Read the results at 15-20 minutes.
Note: Results after 20 minutes may not be accurate.
INTERPRETATION OF RESULTS
Positive:
If two colored bands appear within 15-20 minutes with one colored band in the Control Zone (C) and another in the Test Zone (T), the test result is positive and valid. No matter how faint the colored band is in the Test Zone (T), the result should be considered as positive. A positive result does not rule out co-infections with other pathogens. Negative:
If one colored band appears in the Control Zone (C) and no colored band appears in the Test Zone (T) within 15-20 minutes, the test result is negative and valid. A negative result does not exclude SARS-CoV-2 viral infection and should be confirmed by molecular diagnostic method if COVID-19 disease is suspected. Invalid result:
The test result is invalid if there is no colored band in the Control Zone (C) within 15-20 minutes. Repeat the test with a new test device.
QUALITY CONTROL
1. The control band is an internal reagent and procedural control. It will appear if the test has been performed correctly and the reagents are reactive. 2. Good Laboratory Practice recommends the daily use of control materials to validate the reliability of the device. Control materials which are not provided with this test kit are commercially available.
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PERFORMANCE CHARACTERISTICS
Analytical Sensitivity
The limit of detection (LoD) for the Rapid SARS-CoV-2 Antigen Test Card was established in an analytical sensitivity study performed with one virus strain and one recombinant nucleocapsid protein. The LoD was confirmed in the following table.
No. Item Limit of Detection
1 SARS-CoV-2, Virus 1.3 x102 TCID50/mL 2 SARS-CoV-2, Recombinant nucleocapsid protein 1 ng/mL
Cross Reactivity
The cross reactivity of the Rapid SARS-CoV-2 Antigen Test Card was evaluated with a total of 27 microorganisms. None of the microorganisms tested in the following table gave a positive result.
Microorganisms Concentrations Microorganisms Concentrations Human coronavirus 229E 2.0 x 106 TCID50/mL MERS-coronavirus 1.0 x 105 TCID50/mL Human coronavirus OC43 2.0 x 106 TCID50/mL Chlamydia pneumoniae 2.0 x 106 IFU/mL Human coronavirus NL63 2.0 x 106 TCID50/mL Streptococcus pneumoniae 2.0 x 106 CFU/mL
Parainfluenza virus 1 2.0 x 106 TCID50/mL Streptococcus pyogenes 2.0 x 106 CFU/mL Parainfluenza virus 2 2.0 x 106 TCID50/mL Bordetella pertussis 2.0 x 106 CFU/mL Parainfluenza virus 3 2.0 x 106 TCID50/mL Mycobacterium tuberculosis 2.0 x 106 CFU/mL
Enterovirus EV71 2.0 x 106 TCID50/mL Legionella pneumophila 2.0 x 106 CFU/mL Respiratory syncytial virus 2.0 x 106 TCID50/mL Mycoplasma pneumoniae 2.0 x 106 U/mL
Rhinovirus 2.0 x 106 TCID50/mL Haemophilus influenzae 2.0 x 106 CFU/mL Influenza A virus (H1N1) 2.0 x 106 TCID50/mL Candida albicans 2.0 x 106 CFU/mL Influenza A virus (H3N2) 2.0 x 106 TCID50/mL Staphylococcus aureus 2.0 x 106 CFU/mL
Influenza B virus (Yamagata) 2.0 x 106 TCID50/mL Pseudomonas aeruginosa 2.0 x 106 CFU/mL Influenza B virus (Victoria) 2.0 x 106 TCID50/mL Escherichia coli 2.0 x 106 CFU/mL
Adeno virus 2.0 x 106 TCID50/mL Interference
1. Microorganism Rapid SARS-CoV-2 Antigen Test Card has tested samples with common microorganism. The results showed that these microorganism had no effect on the specificity of the assay up to the listed concentration.
Microorganisms Concentrations Microorganisms Concentrations Human coronavirus 229E 2.0 x 106 TCID50/mL MERS-coronavirus 1.0 x 105 TCID50/mL Human coronavirus OC43 2.0 x 106 TCID50/mL Chlamydia pneumoniae 2.0 x 106 IFU/mL Human coronavirus NL63 2.0 x 106 TCID50/mL Streptococcus pneumoniae 2.0 x 106 CFU/mL
Parainfluenza virus 1 2.0 x 106 TCID50/mL Streptococcus pyogenes 2.0 x 106 CFU/mL Parainfluenza virus 2 2.0 x 106 TCID50/mL Bordetella pertussis 2.0 x 106 CFU/mL Parainfluenza virus 3 2.0 x 106 TCID50/mL Mycobacterium tuberculosis 2.0 x 106 CFU/mL
Enterovirus EV71 2.0 x 106 TCID50/mL Legionella pneumophila 2.0 x 106 CFU/mL Respiratory syncytial virus 2.0 x 106 TCID50/mL Mycoplasma pneumoniae 2.0 x 106 U/mL
Rhinovirus 2.0 x 106 TCID50/mL Haemophilus influenzae 2.0 x 106 CFU/mL Influenza A virus (H1N1) 2.0 x 106 TCID50/mL Candida albicans 2.0 x 106 CFU/mL Influenza A virus (H3N2) 2.0 x 106 TCID50/mL Staphylococcus aureus 2.0 x 106 CFU/mL
Influenza B virus (Yamagata) 2.0 x 106 TCID50/mL Pseudomonas aeruginosa 2.0 x 106 CFU/mL Influenza B virus (Victoria) 2.0 x 106 TCID50/mL Escherichia coli 2.0 x 106 CFU/mL
Adeno virus 2.0 x 106 TCID50/mL
2. Endogenous Substances Rapid SARS-CoV-2 Antigen Test Card has tested samples with common endogenous substances. The results showed that these substances had no effect on the specificity of the assay up to the listed concentration.
Substances Concentrations Substances Concentrations Whole Blood 1% v/v Homeopathic (Alkalol) 10% v/v
Mucin 2% w/v CVS Nasal Drops (Phenylephrine) 15% v/v Tobramycin 0.0004% w/v Afrin (Oxymetazoline) 15% v/v
Ricola (Menthol) 0.15% w/v CVS Nasal Spray (Cromolyn) 15% v/v Chloraseptic (Benzocaine) 0.15% w/v Fluticasone Propionate 5% v/v
Mupirocin 0.25% w/v Zicam 5% w/v Tamiflu (Oseltamivir Phosphate) 0.5% w/v
Accuracy
The accuracy of Rapid SARS-CoV-2 Antigen Test Card was established with 1027 specimens collected from individual symptomatic patients (within 7 days of onset) who were suspected of COVID-19. The following table summarizes the accuracy of the Rapid SARS-CoV-2 Antigen Test Card compared to RT-PCR.
RT-PCR
Positive Negative Total
Rapid SARS-CoV-2 Antigen Test Card
Positive 301 6 307 Negative 12 708 720
Total 313 714 1027
The sensitivity was 96.17% (95%CI: 94.04%~98.29%). The specificity was 99.16% (95%CI: 98.49%~99.83%). The accuracy was 98.25% (95%CI: 97.44%~99.05%). LIMITATIONS
1. The test is limited to the qualitative detection of SARS-CoV-2 viral antigen in nasal swab, nasopharyngeal swab or oropharyngeal swab specimens. The exact concentration of SARS-CoV-2 viral antigen cannot be determined by this assay. 2. Proper specimen collection is critical, and failure to follow the procedure may give inaccurate results. Improper specimen collection, storage or repeated freezing and thawing of specimens can lead to inaccurate results. 3. A negative test result may occur if the level of antigen in a specimen is below the limit of detection of the test. 4. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated. 5. Negative test results do not rule out other potential non-SARS-CoV-2 viral infections. Negative results should be confirmed by molecular diagnosis if COVID-19 disease is suspected. 6. Positive test results do not rule out co-infections with other pathogens. 7. Monoclonal antibodies may fail to detect, or detect with less sensitivity, SARS-CoV-2 viruses that have undergone minor amino acid changes in the target epitope region. 8. The amount of antigen in a sample may decrease as the duration of illness increases. Specimens collected after day 5-7 of illness are more likely to be tested negative compared to a RT-PCR assay. 9. The Rapid SARS-CoV-2 Antigen Test Card can detect both viable and non-viable SARS-CoV-2 material. The Rapid SARS-CoV-2 Antigen Test Card for rapid detection of SARS-CoV-2 performance depends on antigen load and may not correlate with other diagnostic methods performed on the same specimen. 10. The performance of this test has not been evaluated for use in patients without signs and symptoms of respiratory infection and performance may differ in asymptomatic individuals. 11. The kit was validated with the assorted swabs. Use of alternative swabs may result in false negative results. 12. Specimen stability recommendations are based upon stability data from influenza testing and performance may be different with SARS-CoV-2. Users should test specimens as quickly as possible after specimen collection, and within two hours after specimen collection. 13. The validity of Rapid SARS-CoV-2 Antigen Test Card has not been proven for dentification/confirmation of tissue culture isolates and should not be used in this capacity. 14. The sensitivity of nasal swab specimens and oropharyngeal swab specimens might be lower than nasopharyngeal swab specimens. It is recommended to use the nasopharyngeal swab specimens. REFERENCES
1. Wu C, Liu Y, Yang Y, Zhang P, Zhong W, Wang Y, et al. (February 2020). "Analysis of therapeutic targets for SARS-CoV-2 and discovery of potential drugs by computational methods". Acta Pharmaceutica Sinica B. doi:10.1016. EXPLANATION FOR SYMBOLS
In Vitro Diagnostics Use
See Instruction for Use
Expiry Date
Tests per Kit
Keep Dry
Batch Number
Authorized Representative
Keep away from Sunlight
Manufacturer
Do not reuse
Do not use if package is damaged 4°C
30°C
Store between 4 ~ 30°C
CE Mark
Catalogue Number
Warning, please refer to the instruction
Manufacturer:
Xiamen Boson Biotech Co., Ltd. 90-94 Tianfeng Road, Jimei North Industrial Park, Xiamen, Fujian, 361021, P.R.China. Tel: 86-592-3965101 Fax: 86-592-3965155 Email: [email protected] www.bosonbio.com
Authorized
Representative:
Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. Tel: +31644168999 Email: [email protected]
Page 2 of 2 082027 / 210224
English RAPID SARS-COV-2 ANTIGEN TEST CARD
INSTRUCTION GUIDE FOR ANTERIOR NASAL SWAB SPECIMENS For self-testing
1N40C5-2 For 1 Test/Box
1N40C5-4 For 5 Tests/Box
1N40C5-6 For 20 Tests/Box
Please follow the instruction leaflet carefully. INTENDED USE Rapid SARS-CoV-2 Antigen Test Card is an immunochromatography based one step in vitro test. It is designed for the rapid qualitative determination of SARS-CoV-2 virus antigen in anterior nasal swabs from individuals suspected of COVID-19 within the first seven days of symptom onset. Rapid SARS-CoV-2 Antigen Test Card shall not be used as sole basis to diagnose or exclude SARS-CoV-2 infection. Children under 14 years of age should be assisted by an adult. SUMMARY The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection, asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases. MATERIALS PROVIDED
Components For 1 Test/Box For 5 Tests/Box For 20 Tests/Box Rapid SARS-CoV-2 Antigen Test Card (sealed foil pouch) 1 5 20 Sterile swab 1 5 20 Extraction tube 1 5 20 Sample extraction buffer 1 5 20 Instructions for use (this leaflet) 1 1 1 Tube stand 1 (packaging) 1 1
PERFORMANCES (SENSITIVITY AND SPECIFICITY) Rapid SARS-CoV-2-Antigen Test Card was compared to the confirmed clinical diagnosis. The Study involved 156 samples.
Sensitivity 96,77% Specificity 99,20% Accuracy 98,72%
A feasibility study demonstrated that: - 99,10% of non-professionals carried out the test without requiring assistance - 97,87% of the different types of results were interpreted correctly INTERFERENCES None of the following substances at the tested concentration showed any interference with the test.
Whole Blood: 1% Alkalol: 10% Mucin: 2% Phenylephrine: 15% Tobramycin: 0,0004% Oxymetazoline: 15% Menthol: 0,15% Cromolyn: 15% Benzocaine: 0,15% Fluticasone Propionate: 5% Mupirocin: 0,25% Zicam Nasal Spray: 5% Oseltamivir Phosphate: 0,5% sodium chloride: 5% Human Anti-mouse Antibody (HAMA):
60 ng/mL Biotin: 1200 ng/mL IMPORTANT INFORMATION BEFORE THE EXECUTION 1. Read this instruction guide carefully. 2. Do not use the product beyond the expiration date. 3. Do not use the product if the pouch is damaged or the seal is broken. 4. Store the test device at 4 to 30°C in the original sealed pouch. Do Not Freeze. 5. The product should be used at room temperature (15°C to 30°C). If the product has been stored in a cool area (less than 15°C), leave it at normal room
temperature for 30 minutes before using. 6. Handle all specimens as potentially infectious. 7. Inadequate or inappropriate specimen collection, storage, and transport may yield inaccurate test results. 8. Use the swabs included in the test kit to ensure optimal performance of the test. 9. Correct specimen collection is the most important step in the procedure. Make sure to collect enough specimen material (nasal secretion) with the
swab, especially for anterior nasal sampling. 10. Blow the nose several times before collecting specimen. 11. The specimens should be tested as soon as possible after collection. 12. Apply the drops of test specimen only to the specimen well (S). 13. Too many or too few drops of extraction solution can lead to an invalid or incorrect test result. 14. When used as intended, there should not be any contact with the extraction buffer. In case of contact with skin, eyes, mouth or other parts, rinse with
clear water. If an irritation persists, consult a medical professional. 15. Children under 14 years of age should be assisted by an adult. LIMITATIONS 1. The test is to be used exclusively for the qualitative detection of SARS-CoV-2 viral antigen in anterior nasal swab specimens. The exact concentration
of SARS-CoV-2 viral antigen cannot be determined as part of this test. 2. Proper specimen collection is critical. Failure to follow the procedure may result in inaccurate test results. Improper collection, storage, or even freezing
and thawing of the specimen can lead to inaccurate test results. 3. If the viral load of the specimen is below the detection limit of the test, the test may produce a negative result. 4. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test, but should be made by the physician after
evaluation of all clinical and laboratory results. 5. A negative result does not exclude viral infection except for SARS-CoV-2 and should be confirmed by molecular diagnostic methods if COVID-19 is
suspected. 6. A positive result does not exclude coinfection with other pathogens. 7. The SARS-CoV-2 rapid antigen test can detect both viable and non-viable SARS-CoV-2 material. The performance of the SARSCoV-2 rapid test is
dependent on viral load and may not correlate with other diagnostic methods performed on the same specimen. 8. Users should test specimens as soon as possible after specimen collection and within two hours of specimen collection. 9. Sensitivity for nasal or oropharyngeal swabs may be lower than nasopharyngeal swabs. It is recommended to use the nasopharyngeal swab
specimens by healthcare professionals. 10. Monoclonal antibodies may fail to detect, or detect with less sensitivity, SARS-CoV-2 viruses that have undergone minor amino acid changes in the
target epitope region. 11. The amount of antigen in a sample may decrease as the duration of illness increases. Specimens collected after day 5-7 of illness are more likely to be
tested negative compared to a RT-PCR assay. 12. The kit was validated with the assorted swabs. Use of alternative swabs may result in false negative results. 13. The validity of Rapid SARS-CoV-2 Antigen Test Card has not been proven for identification/confirmation of tissue culture isolates and should not be
used in this capacity. 14. Cross-reactivity of the Test Device was evaluated by testing viruses and other microorganisms. The final test concentrations of viruses and other
microorganisms are documented in the Cross-Reactivity-Study. The therein following viruses and other microorganisms except the Human SARS-coronavirus have no effect on the test results of the Test Device. Positive test results do not rule out co-infections with other pathogens. Positive results may occur in cases of infection with SARS-CoV.
PREPARATION z Clear, clean and dry a flat surface. z Check the test kit contents. Make sure that nothing is damaged or broken. z Timer at hand. z Blow your nose several times before collecting specimen. z Wash hands. DISPOSAL The test kit may be disposed of with normal household waste in accordance with the applicable local regulations. PROCEDURE This test is suitable for people of all ages. The recommended operators are aging from 14 to 90. Children under 14 years of age should be tested by an adult. Do not continue the test if the child feels any pain.
1
Rotate the lid of sample extraction buffer bottle. Caution: Open it away from your face and be careful not to spill any of the liquid.
2
Squeeze all extraction buffer out of the bottle into the extraction tube. Caution: Avoid touching the bottle against the tube.
3
Find the swab in the sealed wrapper in front of you. Identify the soft, fabric tip of the swab.
4
Peel open the swab packaging and gently take out the swab. Caution: Never touch the soft, fabric tip of the swab with your hands.
5 Carefully insert swab into one nostril. The swab tip should be inserted no less than 2.5 cm (1 inch) from the edge of the nostril. Roll swab 3-4 times along the mucosa inside the nostril. Leave swab in the nostril for several seconds. Using the same swab, repeat this process for the other nostril. Withdraw swab from the nasal cavity. Caution: This may feel uncomfortable. Do not insert the swab any deeper if you feel strong resistance or pain.
6
Place swab into extraction tube. Roll swab three to five (3-5) times. Leave swab in extraction buffer for 1 minute.
7
Pinch extraction tube with fingers and remove the solution from swab as much as possible.
8
Install the nozzle cap onto the sample extraction tube tightly.
9
Bring the kit components to room temperature before testing. Open the pouch and remove the card. Place the card on a flat and level surface. Caution: Once opened, the test card must be used immediately.
10
Invert the extraction tube and add 3 drops (about 75 μL) of test specimen into the specimen well (S) by gently squeezing the extraction tube. Caution: The formation of air bubbles in the specimen well (S) must be avoided.
11
Read the results at 15-20 minutes. Caution: Results after 20 minutes may not be accurate. The used device may be disposed of with normal household waste in accordance with the applicable local regulations.
INTERPRETATION OF RESULTS
Positive: If two colored bands appear with one colored band in the Control Zone (C) and another in the Test Zone (T) within 15-20 minutes, the test result is positive. Caution: No matter how faint the colored band is in the Test Zone (T), the result should be considered as positive.
Negative: If one colored band appears in the Control Zone (C) and no colored band appears in the Test Zone (T) within 15-20 minutes, the test result is negative.
Invalid: If no color line appears in the control area (C) within 15-20 minutes, the test is invalid. Repeat the test with a new test card.
QUALITY CONTROL The control line is an integrated reagent and is used to control the procedure. The control line appears when the test has been performed correctly and the reagents are reactive. FREQUENTLY ASKED QUESTIONS (FAQ) 1. How does the detection work? The N protein of the SARS-CoV-2 virus reacts with the stripe-like coating of the test line and, if present, results in a color change, i.e. a red line appears. Therefore, if the sample does not contain any viral proteins or antigens, there will be no red test line (T). 2. When should/can I test myself? You can test yourself whether you have symptoms or not. Studies show that earlier testing within the first 4 days of illness typically means a higher viral load, which is easier to detect. Since the test result is a snapshot valid for that point in time, testing should be repeated as recommended by local authorities. 3. What can affect my test result? What should I pay attention to? Be sure to blow your nose multiple times before collecting the specimen. Be sure to visibly collect sample material (nasal secretions). Perform the test immediately after taking the sample. Follow the instructions for use carefully. Apply the drops of extraction solution only to the sample well (S) Too many or too few drops of extraction solution can lead to an invalid or incorrect test result. 4. The test strip is clearly discolored or smudged? What is the reason for this? Please note that the test card should not be used with more than 3 drops of sample, as the liquid absorption of the test strip is naturally limited. If the control line does not appear or the test strip is badly smudged or discolored, making it unreadable, please repeat the test according to the instructions. 5. I have taken the test, but I don’t see a control line (C). What should I do? Your test result is invalid. Observe the answer to question 4 and repeat the test according to the instructions for use. 6. I am unsure about reading the result. What should I do? For the result to be positive, 2 straight horizontal lines must be clearly visible with the full width of the cassette. If you are still unsure about the results, contact the nearest health facility according to the recommendations of your local authorities. 7. My result is positive. What should I do? If your result is positive and the test kit thus clearly indicates the control line as well as the test line, you should contact the nearest medical facility as recommended by your local authorities. Your test result may be double-checked and the authority or facility will explain the appropriate next steps. 8. My result is negative. What should I do? If the test kit only clearly shows the control line, this may mean that you are negative or that the viral load is too low to be detected. If you experience symptoms (headache, fever, migraine, loss of sense of smell or taste, etc.), please consult your primary care physician, or the nearest health care facility as recommended by your local authorities. If you are not sure, you can repeat the test. 9. How can I dispose of the product? The test kit may be disposed of with normal household waste in accordance with the applicable local regulations.
ACCESSORIES:
Accessory Manufacturer EC-Representative CE-Mark
Swab A Jiangsu Changfeng Medical Industry Co., Ltd. Touqiao Town, Guangling District Yangzhou 225109 Jiangsu P.R. China
Llins Service & Consulting GmbH Obere Seegasse 34/2,69124 Heidelberg Germany
acc. 93/42/EEC
Swab B Goodwood Medical Care Ltd. 1-2 Floor, 3-919 Yonzheng Street Jinzhou District Dalian 116100 Liaoning China
CMC Medical Devices & Drugs S.L. C/ Horacio Lengo No18, CP 29006, Màlaga, Spain
acc. 93/42/EEC
Swab C Zhejiang Gongdong Medical Technology Co., Ltd. No. 10 Beiyuan Ave., Huangyan 318020 Taizhou, Zhejiang, P.R.China
Shanghai International Holding Corp. GmbH (Europe) Eiffestrasse 80, 20537 Hamburg, Germany
acc. 93/42/EEC
Swab D Jiangsu Hanheng Medical Technology Co.,Ltd. 16-B4,#1 North Qingyang Road, Tianning District, 213017, Changzhou, Jiangsu, China
Luxus Lebenswelt GmbH Kochstr.1, 47877, Willich, Germany
acc. 93/42/EEC EXPLANATION FOR SYMBOLS
In Vitro Diagnostics Use
See Instructions for Use
Expiry Date
Tests per Kit
Keep dry
Batch Number
Authorized Representative
Keep away from sunlight
Manufacturer
Do not reuse
Do not use if package is damaged
Store between 4- 30 °C
CE Mark Catalogue Number
Warning, please refer to the instruction
H317: Warning! Liquid component may cause an allergic skin reaction.
Manufacturer:
Xiamen Boson Biotech Co., Ltd. 90-94 Tianfeng Road, Jimei North Industrial Park, Xiamen, Fujian, 361021, P.R.China.
Authorized Representative:
Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands.
Version 5.1 Date: April 25th, 2021
Svenska / Swedish SARS-COV-2-ANTIGENSNABBTEST
BRUKSANVISNING FÖR PROV TAGET MED TOPS I NÄSBORREN (FRÄMRE NÄSAN) För självtest
1N40C5-2 För 1 test/kartong
1N40C5-4 För 5 tester/kartong
1N40C5-6 För 20 tester/kartong Följ bruksanvisningen.
ANVÄNDNINGSOMRÅDE SARS-CoV-2-antigensnabbtestet är ett enstegs in vitro självtest som baseras på immunokromatografi. Självtestet har utvecklats för snabb, kvalitativ bestämning av SARS-CoV-2-virusantigen i prov taget med tops i näsborren (främre näsan) på personer med misstänkt COVID-19 inom de sju första dagarna efter uppkomna symptom. SARS-CoV-2-antigensnabbtestet skall inte användas som enda grundval för diagnos eller uteslutning av en SARS-CoV-2-infektion. Barn under 14 år bör få hjälp av en vuxen. SAMMANFATTNING Det nyupptäckta coronaviruset är ett ß-coronavirus. COVID-19 är en smittsam och akut luftvägssjukdom. Människor är generellt mottagliga. För närvarande utgör patienter som infekterats av det nya coronaviruset den största infektionskällan, där även personer utan symtom kan utgöra en infektionskälla. Aktuella epidemiologiska undersökningar pekar på en inkubationstid på 1–14 dagar, för det mesta dock 3–7 dagar. De viktigaste symptomen är bland annat feber, trötthet, förlust av lukt- och/eller smaksinne samt torrhosta. I några fall har även symptom som nästäppa, rinnande näsa, halsont, muskelsmärtor och diarré påvisats. MEDFÖLJANDE MATERIAL
Beståndsdelar För 1 test/kartong För 5 tester/kartong För 20 tester/kartong Testkassett för SARS-CoV-2-antigen (förseglad foliepåse) 1 5 20 Steril topspinne 1 5 20 Provrör 1 5 20 Buffert 1 5 20 Bruksanvisning (denna bilaga) 1 1 1 Provrörshållare 1 (i kartongen) 1 1
PRESTANDA (SENSITIVITET OCH SPECIFICITET) SARS-CoV-2-antigensjälvtestet har i studie jämförts med laboratoriebekräftad klinisk diagnos för SARS-CoV-2 infektion. I studien har 156 prover testats med resultat enligt tabellen nedan.
Sensitivitet 96,77 % Specificitet 99,20 % Noggrannhet 98,72 %
En sannolikhetstudie uppvisade följande resultat: - 99,10 % av icke-professionella användare genomförde testet framgångsrikt på egen hand - 97,87 % av de olika typerna av resultaten tolkades på rätt sätt INTERFERENSER Inga av följande substanser i den testade koncentrationen interfererade med testet.
Helblod: 1 % Alkalol: 10 % Mucin: 2 % Fenylefrin: 15 % Tobramycin: 0,0004 % Oximetazolin: 15 % Mentol: 0,15 % Kromoglicinsyra: 15 % Bensokain: 0,15 % Flutikasonpropionat: 5 % Mupirocin: 0,25 % Zicam nässpray: 5 % Oseltamivirfosfat: 0,5 % Natriumklorid: 5 % Human anti-musantikropp (HAMA): 60 ng/mL Biotin: 1200 ng/mL
VIKTIG INFORMATION INFÖR GENOMFÖRANDET 1. Läs denna bruksanvisning noga. 2. Använd inte produkten efter utgångsdatum. 3. Använd inte produkten om påsen är skadad eller om förseglingen har brutits. 4. Förvara testet i den förseglade originalpåsen i en temperatur på 4–30 °C. Frys inte testet. 5. Produkten ska användas i rumstemperatur (15–30 °C). Om produkten har förvarats i en lägre temperatur (under 15 °C) ska den stå i normal
rumstemperatur i 30 minuter innan den används. 6. Hantera alla prover som eventuellt smittsamma. 7. Om provtagning samt förvaring och transport av proverna utförs felaktigt eller slarvigt kan testresultaten bli otillförlitliga. 8. Använd den topspinne som ingår i testkitet för bästa möjliga genomförande av provtagningen. 9. Rätt genomförd topsning är det viktigaste steget i provtagningen. Se till att du samlar upp tillräckligt mycket provmaterial (nässekret) från
näsborren. 10. Snyt dig flera gånger före provtagningen. 11. Proverna ska undersökas så snart som möjligt efter provtagningen. 12. Droppa testprovet endast i provbrunnen (S). 13. För många eller för få droppar av bufferten kan ge ett ogiltigt eller felaktigt testresultat. 14. Undvik direktkontakt med bufferten när du använder produkten. Om hud, ögon, mun eller annan kroppsdel får buffert på sig, skölj med rent vatten.
Om en irritation kvarstår, kontakta läkare. 15. Barn under 14 år bör få hjälp av en vuxen. BEGRÄNSNINGAR: 1. Testet är endast avsett för kvalitativ påvisning av SARS-CoV-2-virusantigen vid prov taget med topspinne i näsborren (i främre näsan). Den exakta
koncentrationen av SARS-CoV-2-virusantigen kan inte bestämmas med detta test. 2. Det är mycket viktigt att provtagningen sker på rätt sätt. Om anvisningarna inte följs kan testresultaten bli otillförlitliga. Felaktig provtagning,
förvaring eller infrysning och upptining av provet kan leda till otillförlitliga testresultat. 3. Om provets virusbelastning ligger under testets detektionsgräns kan resultatet av provtagningen bli negativt. 4. Som vid alla diagnostiska tester bör en slutgiltig klinisk diagnos inte baseras på resultatet från en enda provtagning. Diagnosen bör i stället ställas
av läkaren efter utvärdering av alla kliniska resultat och laboratoriefynd. 5. Ett negativt resultat utesluter inte en viral infektion med SARS-CoV-2 och bör bekräftas med molekylärdiagnostiska metoder (tex PCR test) vid
misstanke om COVID-19. 6. Ett positivt resultat utesluter inte en samtidig infektion av annan orsak. 7. SARS-CoV-2-antigensnabbtestet kan påvisa såväl livskraftigt som icke-livskraftigt SARS-CoV-2-material. SARSCoV-2-snabbtestets prestanda
beror på virusmängd och korrelerar eventuellt inte med andra diagnosmetoder som använts på samma prov. 8. Vid användning av självtestet skall själva provmaterialet från näsborren, efter extraktion till provröret, snarast möjligt och senast inom två timmar
droppas ner i testkasetten. 9. Om medicinsk fackpersonal använder detta självtest rekommenderas nasofaryngeal topsning eftersom nasofaryngeal topsning anses ha högre
känslighet än topsning i näsborre. 10. SARS-CoV-2-antigensnabbtestet kan vara sämre på att detektera SARS-CoV-2 virus som har förändrad aminosyrasekvens (muterat). 11. Mängden antigen i ett prov kan avta med sjukdomstiden. Prover som tas efter den femte till sjunde sjukdomsdagen har större sannolikhet att visa
ett negativt resultat jämfört med en RT-PCR-analys. 12. Kitet har validerats med de medföljande topspinnarna. Om andra topspinnar används kan följden bli falska negativa resultat. 13. SARS-CoV-2-antigensnabbtestet har inte verifierats för identifiering av virus i vävnadskulturisolat och skall inte användas i detta syfte. 14. Testkassettens korsreaktivitet har utvärderats genom testning av virus och andra mikroorganismer. De slutgiltiga testkoncentrationerna av virus
och andra mikroorganismer finns dokumenterade i en Cross-Reactivity-studie. De virus och andra mikroorganismer som anges där har, med undantag för SARS-CoV-1, ingen inverkan på testkassettens testresultat. Positiva testresultat utesluter inte samtidig infektion av annan orsak. Positiva resultat kan uppträda i fall med en infektion med det närbesläktade viruset SARS-CoV-1.
TESTPROCEDUR: z Rengör och torka av en plan, fri yta. z Kontrollera testkitets innehåll z Säkerställ att inga delar är skadade eller trasiga. z Håll ett tidur redo. z Snyt dig flera gånger före provtagningen. z Tvätta händerna. AVFALLSHANTERING Testkitet kan slängas i det normala hushållsavfallet i enlighet med gällande, lokala föreskrifter. FÖRFARANDE:
1
Öppna buffertlösningen. VARNING: Öppna den bortvänd från ansiktet och var försiktig så att ingen vätska spills ut.
2
För över all buffertlösningen till provröret. VARNING: Se till att de båda behållarna inte vidrör varandra.
3
Leta fram den separata, förseglade förpackningen med topspinnen. Se var den mjuka textilspetsen på topspinnen är placerad.
4
Öppna förpackningen och ta försiktigt ut topspinnen. VARNING: Undvik att vidröra topspinnens mjuka textilspets med händerna.
5 För varsamt in topspinnen i ena näsborren. Topspinnens spets ska föras in minst 2,5 cm från näsborrens kant. Vrid topspinnen längs slemhinnan i näsborren så att både slem och celler samlas in. Vrid topspinnen tre till fyra (3–4) gånger. Lämna topspinnen i näsborren några sekunder. Upprepa samma förfarande med samma topspinne i den andra näsborren. VARNING: Detta kan upplevas som obehagligt. För inte topspinnen längre in om du känner ett starkt motstånd eller smärta.
6
Placera topspinnen med provet i provröret. Vrid nu topspinnen tre till fem (3–5) gånger. Lämna topspinnen i bufferten i en minut.
7
Tryck ihop provröret med fingrarna och avlägsna så mycket av lösningen som möjligt från topspinnen samtidigt som du drar ut topspinnen. Släng sedan topspinnen.
8
Sätt på locket på provröret.
9
Se till att kitets delar har rumstemperatur innan testet genomförs. Öppna påsen och ta ut testkassetten. Lägg testkassetten på en jämn och plan yta. VARNING: När testkassetten har öppnats måste den användas omedelbart.
10
Vänd på provröret och droppa ned tre droppar (75 μl) av provet i provbrunnen (S) genom att lätt trycka ihop provröret. VARNING: Se till att det inte bildas luftbubblor i provbrunnen (S).
11
Resultatet visas efter 15–20 minuter. Varning: Efter mer än 20 minuter kan resultatet bli felaktigt. Det förbrukade kitet kan slängas i det normala hushållsavfallet i enlighet med gällande, lokala föreskrifter.
TOLKNING AV TESTRESULTAT
Positivt: Om det inom 15–20 minuter framträder två färglinjer – en färglinje i kontrollområdet (C) och en färglinje i testområdet (T) – är testresultatet giltigt och positivt. Resultatet ska anses vara positivt, oavsett hur svag färglinjen är i testområdet (T). Ett positivt resultat utesluter inte samtidig infektion av annan orsak.
Negativt: Om det inom 15–20 minuter framträder en färglinje i kontrollområdet (C), men inte i testområdet (T), är testresultatet giltigt och negativt. Ett negativt resultat utesluter inte en virusinfektion med SARS-CoV-2 och bör bekräftas med molekylärdiagnostiska metoder (tex PCR) vid misstanke om COVID-19.
Ogiltigt: Om det inom 15–20 minuter inte framträder någon färglinje i kontrollområdet (C) är testresultatet ogiltigt. Gör om testet med en ny testkassett.
KVALITETSKONTROLL Kontrollinjen är en integrerad reagens med funktionen att kontrollera förfarandet. Kontrollinjen framträder när testet genomförts på rätt sätt och då reagenserna är reaktiva. FRÅGOR OCH SVAR (FAQ) 1. Hur fungerar detekteringen? SARS-CoV-2-virusets N-protein reagerar med testlinjens beläggning och orsakar en färgskiftning som gör att en röd linje framträder. Om provet inte innehåller virusprotein resp. antigener uppstår ingen röd testlinje (T). 2. När bör/kan jag testa mig själv? Du kan testa dig själv oavsett om du har symptom eller inte. Studier har visat att tidiga tester under de fyra första sjukdomsdagarna innebär en högre virusbelastning som är enklare att detektera. Eftersom testresultatet är en giltig ögonblicksbild från denna tidpunkt bör testerna upprepas enligt de lokala myndigheternas rekommendationer. 3. Vad kan påverka mitt testresultat? Vad bör jag tänka på? Snyt dig noga för provtagningen. Se till att du samlar in synligt provmaterial (nässekret). Genomför testet direkt efter provtagningen. Följ bruksanvisningen noga. Droppa bufferten endast i provbrunnen (S). För många eller för få droppar av bufferten kan ge ett ogiltigt eller felaktigt testresultat. 4. Testremsan är tydligt missfärgad eller suddig. Vad beror det på? Tänk på att testkassetten inte får användas med mer än tre droppar av provet, eftersom testremsans vätskeupptagning har en naturlig begränsning. Om kontrollinjen inte framträder eller om testremsan är mycket suddig eller missfärgad, och därmed oläslig, ska du göra om testet enligt anvisningarna. 5. Jag har gjort testet, men ser ingen kontrollinje (C). Vad ska jag göra? Ditt testresultat är ogiltigt. Se svaret på fråga 4 och gör om testet enligt bruksanvisningen. 6. Jag är osäker på hur jag ska läsa av resultatet. Vad ska jag göra? För att resultatet ska anses vara positivt måste två raka, vågräta linjer över kassettens hela bredd vara tydligt synliga. Om du fortfarande är osäker på resultaten ska du vända dig till närmaste vårdinrättning enligt de lokala myndigheternas rekommendationer. 7. Mitt resultat är positivt. Vad ska jag göra? Om ditt resultat är positivt, vilket innebär att testkitet tydligt visar både kontrollinjen och testlinjen, ska du vända dig till närmaste vårdinrättning enligt de lokala myndigheternas rekommendationer. Ditt testresultat dubbelkontrolleras eventuellt och myndigheten eller vårdinrättningen förklarar vilka steg som sedan följer. 8. Mitt resultat är negativt. Vad ska jag göra? Om testkitet endast visar en tydlig kontrollinje kan det betyda att du är negativ eller att virusbelastningen är för låg för att detekteras. Om du upplever symptom (huvudvärk, feber, migrän, förlust av lukt- eller smaksinne osv.) ska du rådgöra med din läkare eller närmaste vårdinrättning enligt de lokala myndigheternas rekommendationer. Om du inte är säker kan du göra om testet. 9. Hur ska jag avfallshantera testkitet? Testkitet kan slängas i det normala hushållsavfallet i enlighet med gällande, lokala föreskrifter. TILLBEHÖR: Tillbehör Tillverkare Auktoriserad representant inom EU CE-märkning
Topspinne A Jiangsu Changfeng Medical Industry Co., Ltd. Touqiao Town, Guangling District Yangzhou 225109 Jiangsu P.R. China
Llins Service & Consulting GmbH Obere Seegasse 34/2,69124 Heidelberg Germany
enligt 93/42/EEG
Topspinne B Goodwood Medical Care Ltd. 1-2 Floor, 3-919 Yonzheng Street Jinzhou District Dalian 116100 Liaoning China
CMC Medical Devices & Drugs S.L. C/ Horacio Lengo No18, CP 29006, Màlaga, Spain
enligt 93/42/EEG
Topspinne C Zhejiang Gongdong Medical Technology Co., Ltd. No. 10 Beiyuan Ave., Huangyan 318020 Taizhou, Zhejiang, P.R.China
Shanghai International Holding Corp. GmbH (Europe) Eiffestrasse 80, 20537 Hamburg, Germany
enligt 93/42/EEG
Topspinne D Jiangsu Hanheng Medical Technology Co.,Ltd. 16-B4,#1 North Qingyang Road, Tianning District, 213017, Changzhou, Jiangsu, China
Luxus Lebenswelt GmbH Kochstr.1, 47877, Willich, Germany
enligt 93/42/EEG FÖRKLARING AV SYMBOLER PÅ FÖRPACKNINGEN:
In vitro-diagnostiktest
Bruksanvisning
Utgångsdatum
Tester per kit (innehåll)
Förvaras torrt
Partinummer
Auktoriserad representant
Förvaras skyddad mot solljus
Tillverkare
Får inte återanvändas (engångsprodukt)
Får inte användas om förpackningen är
skadad
Förvaras i 4–30 °C
CE-märkning
Artikelnummer
Obs, se bruksanvisningen
H317: Varning! Flytande komponenter (buffert) kan orsaka allergiska hudreaktioner.
Tillverkare:
Xiamen Boson Biotech Co., Ltd. 90-94 Tianfeng Road, Jimei North Industrial Park, Xiamen, Fujian, 361021, P.R.China.
Auktoriserad representant:
Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands.
Version 5.1 Datum: den 25 april 2021 Norsk / Norwegian
SARS-COV-2-ANTIGENS HURTIGPRØVE INSTRUKSJONER FOR BRUK FOR PRØVER MED TOPPER I DYSEN (FRONT NESE)
For selvtest
1N40C5-2 For 1 test/kartong
1N40C5-4 For 5 tester/kartong
1N40C5-6 For 20 tester/kartong Følg bruksanvisningen. BRUKSOMRÅDE SARS-CoV-2-antigen-hurtigprøve er en et-trinn in-vitro selvtest basert på immunokromatografi. Selvtesten er utviklet for rask, kvalitativ bestemmelse av SARS-CoV-2-virusantigen i prøver tatt i nesebor (nese foran) på personer med mistanke om COVID-19 i løpet av de første syv dagene etter symptomdebut. SARS-CoV-2-antigen-hurtigprøve skal ikke brukes som eneste grunnlag for diagnostisering eller ekskludering av en SARS-CoV-2-infeksjon. Barn under 14 år bør assisteres av en voksen. SAMMENDRAG Det nylige oppdagede koronaviruset er et ß-koronavirus. COVID-19 er en smittsom og akutt luftveissykdom. Folk er generelt mottakelige. Pasienter smittet med det nye koronaviruset er den største infeksjonskilden, der selv personer uten symptomer kan være en kilde til infeksjon. Nåværende epidemiologiske studier indikerer en inkubasjonsperiode på 1–14 dager, men hovedsakelig 3–7 dager. De viktigste symptomene inkluderer feber, tretthet, tap av luktesans og / eller smak og tørr hoste. I noen tilfeller er det også rapportert om symptomer som tetthet i nese, rennende nese, ondt i halsen, muskelsmerter og diaré. INKLUDERT MATERIAL
Bestandsdeler For 1 test/kartong For 5 tester/kartong For 20 tester/kartong Testpatron for SARS-CoV-2 antigen (forseglet foliepose) 1 5 20 Steril vattpinne 1 5 20 Prøverør 1 5 20 Buffer 1 5 20 Bruksanvisning (dette tillegget) 1 1 1 Prøverørholder 1 (i kartongen) 1 1
YTELSE (SENSITIVITET OG SPESIFISITET) SARS-CoV-2-antigen-hurtigprøve har blitt sammenlignet i en studie med en laboratoriebekreftet klinisk diagnose av SARS-CoV-2-infeksjon. I studien ble 156 prøver testet med resultatene i henhold til tabellen nedenfor.
Følsomhet 96,77 % Spesifisitet 99,20 % Nøyaktighet 98,72 %
En sannsynlighetsstudie viste følgende resultater: - 99,10% av ikke-profesjonelle brukere fullførte testen på egenhånd - 97,87% av de forskjellige resultatene ble tolket riktig INTERFERENS Ingen av følgende stoffer i den testede konsentrasjonen forstyrret testen.
Fullblod: 1 % Alkalol: 10 % Mucin: 2 % Fenylefrin: 15 % Tobramycin: 0,0004 % Oksimetazolin: 15 % Mentol: 0,15 % Kromoglicinsyre: 15 % Bensokain: 0,15 % Flutikasonpropionat: 5 % Mupirocin: 0,25 % Zicam nesespray: 5 % Oseltamivir fosfat: 0,5 % Natriumklorid: 5 % Humant anti-musantistoff (HAMA):
60 ng/ml Biotin: 1200 ng/ml VIKTIG INFORMASJON FOR GJENNOMFØRING 1. Les denne håndboken nøye. 2. Ikke bruk produktet etter utløpsdatoen. 3. Ikke bruk produktet hvis posen er skadet eller hvis forseglingen er ødelagt. 4. Oppbevar testen i den forseglede originale posen ved en temperatur på 4-30 ° C. Ikke frys testen. 5. Produktet skal brukes ved romtemperatur (15-30 ° C). Hvis produktet har blitt oppbevart ved en lavere temperatur (under 15 ° C), bør det stå i
normal romtemperatur i 30 minutter før bruk. 6. Behandle alle prøvene som om de var smittsomme. 7. Hvis prøvetaking og lagring og transport av prøvene utføres feil eller uforsiktig, kan testresultatene bli upålitelige. 8. Bruk vattpinnen som er inkludert i testsettet for best mulig ytelse av prøvetakingen. 9. Riktig utført pålegg er det viktigste trinnet i prøvetaking. Forsikre deg om at du samler nok prøvemateriale (nesesekresjoner) fra neseboret. 10. Blås ut snørr av nesebor flere ganger før prøvetaking. 11. Prøvene må undersøkes så snart som mulig etter prøvetaking. 12. Slipp testprøven bare ned i prøvebrønnen (S). 13. For mange eller for få dråper av bufferen kan gi et ugyldig eller feil testresultat. 14. Unngå direkte kontakt med bufferen når du bruker produktet. Hvis hud, øyne, munn eller annen kroppsdel får buffer på den, skyll med rent vann.
Rådfør deg med lege hvis irritasjonen vedvarer. 15. Barn under 14 år bør assisteres av en voksen. BEGRENSNINGER: 1. Testen er kun beregnet for kvalitativ påvisning av SARS-CoV-2-virusantigen når den samples med en topp pinne i neseboret (foran nesen). Den
nøyaktige konsentrasjonen av SARS-CoV-2-virusantigen kan ikke bestemmes med denne testen. 2. Det er veldig viktig at prøvetakingen skjer riktig. Unnlatelse av å følge instruksjonene kan føre til upålitelige testresultater. Feil prøvetaking, lagring
eller frysing og tining av prøven kan føre til upålitelige testresultater. 3. Hvis prøvens virusbelastning er under testens deteksjonsgrense, kan prøvetakingsresultatet være negativt. 4. Som med alle diagnostiske tester, bør en endelig klinisk diagnose ikke baseres på resultatene av en enkelt prøvetaking. Diagnosen bør i stedet
stilles av legen etter evaluering av alle kliniske resultater og laboratoriefunn. 5. Et negativt resultat utelukker ikke en virusinfeksjon med SARS-CoV-2 og skal bekreftes ved hjelp av molekylære diagnostiske metoder (f.eks.
PCR-test) hvis det er mistanke om COVID-19. 6. Et positivt resultat utelukker ikke en samtidig infeksjon av en annen årsak. 7. SARS-CoV-2-antigen-hurtigprøve kan oppdage både levedyktig og ikke-levedyktig SARS-CoV-2-materiale. Ytelsen til SARS-CoV-2-hurtigprøve
avhenger av virusmengden og kan ikke korrelere med andre diagnostiske metoder som brukes på samme prøve. 8. Når du bruker selvtesten, må prøvematerialet fra neseboret, etter ekstraksjon til prøverøret, slippes ned i testkassetten så snart som mulig og
senest innen to timer. 9. Hvis helsepersonell bruker denne selvtesten, anbefales nasopharyngeal topping fordi nasopharyngeal topping anses å ha høyere følsomhet enn
nasal topping. 10. SARS-CoV-2-antigen-hurtigprøve kan være dårligere til å oppdage SARS-CoV-2-virus som har endret aminosyresekvensen (mutert). 11. Mengden antigen i en prøve kan reduseres med sykdomsvarighet. Prøver tatt etter den femte til syvende sykdomsdagen viser mer sannsynlig et
negativt resultat sammenlignet med en RT-PCR-analyse. 12. Kittet er validert med de medfølgende toppspinnerne. Hvis andre toppspinnere brukes, kan resultatet være falske negative resultater. 13. SARS-CoV-2-antigen-hurtigprøveen er ikke verifisert for identifisering av virus i vevskulturer og skal ikke brukes til dette formålet. 14. Testkassettens kryssreaktivitet er evaluert ved å teste for virus og andre mikroorganismer. De endelige testkonsentrasjonene av virus og andre
mikroorganismer er dokumentert i en kryssreaktivitetsstudie. Virusene og andre mikroorganismer som er oppført der, med unntak av SARS-CoV-1, har ingen effekt på testresultatene til testpatronen. Positive testresultater utelukker ikke samtidig infeksjon av annen grunn. Positive resultater kan oppstå i tilfeller av infeksjon med nært beslektet, men hos mennesker utryddet virus SARS-CoV-1.
TEST PROSEDYRE: z Rengjør og tørk av en flat, fri overflate. z Sjekk innholdet i testsettet z Forsikre deg om at ingen deler er skadet eller ødelagt. z Hold tidtakeren klar. z Blås snørr ut av nesa forsiktig flere ganger før prøvetaking. z Vask hendene dine. AVFALLSHÅNDTERING Testpakken kan kastes sammen med vanlig husholdningsavfall i samsvar med lokale forskrifter. FREMGANGSMÅTE:
1
Åpne bufferløsningen. ADVARSEL: Åpne den vekk fra ansiktet, og vær forsiktig så du ikke søler væske.
2
Overfør all bufferløsningen til prøverøret. ADVARSEL: Forsikre deg om at de to beholderne ikke berører hverandre.
3
Finn den separate, forseglede pakken med vattpinnen. Se hvor den myke tekstilspissen på den øverste spinneren er plassert.
4
Åpne pakken og fjern den øverste tappen forsiktig. ADVARSEL: Unngå å berøre den myke stoffspissen på toppnålen med hendene.
5 Sett den vattpinnen forsiktig inn i et nesebor. Spissen av vattpinnen skal føres inn minst 2,5 cm fra kanten av neseboret. Vri den øverste pinnen langs slimhinnen i neseboret, slik at både slim og celler blir samlet. Snu vattpinnen tre til fire (3-4) ganger. La den øverste pinnen ligge i neseboret i noen sekunder. Gjenta samme prosedyre med samme vattpinne i det andre neseboret. ADVARSEL: Dette kan oppfattes som ubehagelig. Ikke skyv vattpinnen lenger inn hvis du føler sterk motstand eller smerte.
6
Plasser vattpinnen med prøven i prøverøret. Snu vattpinnen tre til fem (3-5) ganger. La toppstaven ligge i bufferen i ett minutt.
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