INSTRUCTION MANUALThe SARS CoV-2 Antigen Rapid Test is a lateral flow immunoassay for rapid qualitative detection of the N-protein antigen of SARS CoV-2 in swab specimens from both symptomatic and asymptomatic COVID- 19 infected individuals.

SUMMARY AND EXPLANATIONSARS-CoV-2, also known as Covid 19 virus, causes an acute respiratory infectious disease in humans who are generally susceptible. The main source of infection is currently people infected with the virus, even those who have an asymptomatic course. According to recent epidemiological studies, the incubation period varies between 1 to 14 days, but mostly between 3 to 7 days. Typical symptoms at manifestation include fever, fatigue and dry cough. Among others, rhinorrhea, sore throat, myalgias & diarrhea symptoms may occur in rare cases.

PRINCIPLE OF THE TESTQualitative detection of SARS CoV-2 antigens in human throat and nasopharyngeal swabs, sputum, and bronchoalveolar lavage fluid is performed using double antibody sandwich and colloidal gold immunochromatography. Functionally, two highly specific and highly sensitive SARS- CoV- 2 N- antigen monoclonal antibodies are used. Monoclonal antibody I functions as a capture antibody for the NC membrane. Antibody II is a colloidal gold-labeled antibody used primarily for quality control. If SARS-CoV-2 virus is present in the sample during the test, complex formation occurs between monoclonal antibody I and SARS-CoV-2 N antigen. The gold-labeled monoclonal antibody II is used for chromatography. If there is a SARS-CoV-2 antigen complex with the monoclonal antibody I in the T region, the gold-labeled monoclonal antibody II binds to this complex and a purple stripe is formed in the T region. After the gold-labeled monoclonal antibody II has crossed the T-region, it binds to secondary antibodies in the C-region and a purple stripe is formed. The violet stripe in the control region (C) serves as a standard for the qualitative evaluation of the chromatographic process. The presence or absence of the virus has no influence on the reaction in the C region.

UNIBIOSCIENCE SARS-COV/COV2 AG RAPID TEST CE IVD TEST KIT (Colloidal Gold)

COVID-19 ANTIGEN RAPID TEST

REAGENTS AND MATERIALSContents:■ Operating instructions (1)The test kit contains: ■ Test cassette *Individually packed in foil pouch (25) ■ Reagent tube sealed with a cap *Filled with extraction reagent (1000 μL ) (25)■ Screw cap with dropper function (with stopper) (25) ■ Sterile swabs (25)

MATERIALS NOT SUPPLIED IN THE KIT ■ Timer or clock

WARNINGS AND PRECAUTIONS

Section I■ Please read the instruction manual carefully before use. Professionally trained personnel should handle and perform strictly according to the instructions. ■ This product is a single-use in vitro diagnostic product, please use it within the validity period. ■ Do not use the aluminum foil bag if it is damaged. Please use the contents as soon as possible after opening. ■ Temperature has a strong influence on the test results. High temperatures in the test environment should be avoided. Store the test kit at the lowest possible temperature and use it at room temperature to prevent possible moisture absorption.

Section II■ Clinical performance was evaluated with frozen specimens. Test performance may vary with fresh specimens. Tests are not intended for multiple use. Sample stability recommendations are based on stability data from influenza testing and may differ for SARS- CoV- 2. It is recommended that specimens be used as soon as possible, preferably within the first hour of specimen collection. ■ The contents of this kit are to be used only for the qualitative detection of SARS CoV-2 antigens from throat and nasopharyngeal swab specimens. ■ Please use the swab and reagent solution provided in this kit when collecting specimens. Do not mix test cassettes and the reagent. The non-appearance of a line in the quality control area (C) or test area (T) is an error indication. In this case, please test again.

Section III■ Test performance may vary in asymptomatic individuals. ■ Positive and negative predictive values are strongly dependent on prevalence rates. In a high-prevalence setting, the positive predictive value increases-that is, it is more likely that individuals who test positive are truly antigen-positive-than when the test is used in a low-prevalence population. When a test is used in a population where prevalence is low, the positive predictive value decreases because there are more false positives. The negative predictive value is also influenced by prevalence. In a high prevalence setting, the negative predictive value decreases, while it increases in a low prevalence setting. ■ SARS CoV- 2- antigen rapid test results should be considered together with epidemiologic data, clinical history, and other clinically relevant data. ■ A false-negative test result may occur if the concentration of viral antigen in a specimen is below the detection limit of the test or if the specimen was improperly collected or transported. Therefore, a negative result does not exclude the possibility of SARS- CoV-2 infection.

■ If symptoms persist, a negative test result should be reviewed and confirmed with an approved molecular RT-PCR test or clinical treatment should be initiated. ■ The validity of the SARS-CoV-2 antigen rapid test has not been tested for purposes of identification/confirmation of tissue culture isolates and should not be used with this intent. ■ Negative test results are not intended to rule out other non-SARS- CoV 2, viral, or bacterial infections. ■ Monoclonal antibodies may not identify, or may identify with less sensitivity, SARS- CoV 2- viruses that have taken up a minor amino acid and have changes in the target epitope region.

Section IV■ Observe safety measures during the test procedure, such as wearing protective clothing and gloves. Used swabs, test cassettes, extraction, tubes, etc. should be disposed of properly in the laboratory. ■ Ensure cleanliness. Contamination, i.e. potential sources of infection, should be minimized. Testing should be performed in accordance with laboratory safety management regulations.

Waste disposal must be in accordance with ASN 180103*.

KIT STORAGE AND STABILITYStore the kit at room temperature, 2°C to 30°C (35.5°F to 86°F), away from direct sunlight. The contents of the kit are stable until the expiration date printed on the outside of the package.

Protect from moisture and humidity. DO NOT FREEZE.

SAMPLE COLLECTION AND PREPARATION 1. the applicable specimen types of this test reagent: upper respiratory specimens2. For the specific method of specimen collection, RKI refers to "Laboratory biosafety guidance related to coronavirus disease (COVID-19)" of WHO. 3. After specimen collection, the test must be completed on the same day.

TEST PROCEDURECollection of the Sample■ Prior to sample collection, the patient should not have eaten for at least 30 minutes. Remove the cap of the reagent tube and place the tube on a smooth and horizontal surface. To collect a nasopharyngeal swab, tilt the patient's head slightly backward. Then, for the nasopharyngeal swab, gently insert the swab into the nasopharynx via the nasal cavity. Ensure that the swab is inserted horizontally until resistance is reached on the pharyngeal wall. Leave the swab there for a few seconds, then pull it out in a rotating motion. The tip of the swab should be wet.

Sample collection ■ Insert the swab into the reagent tube filled with the reagent solution and stir at least 10 times to dissolve the sample in the solution as much as possible. Bend the swab at the designated point and leave the swab portion in the reagent tube. Then close the reagent tube with the screw cap and leave the sample for 1-3 minutes. Do not open the aluminum foil pouch of the test cassette while taking the sample. Any humid ambient air that may be present could cause the test strip to malfunction in the event of prolonged exposure.

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Results display■ Now remove the test cassette from the aluminum foil pouch and place it on a flat and dry surface. Now squeeze out 2 drops (45-75 μL) of the sample material into the sample well (S) of the test cassette. Then close the screw cap with the stopper fixed on the side so that no sample solution escapes from the reagent tube.

2.Interference ■ No interference for whole blood, mouthwash, phenylephrine,acetylsalicylic acid, beclomethasone, benzocaine, flunisolide, guaiacolglyc-eryl ether, menthol, oxymetazoline, tobramycin, zanamivir, oseltamivir phosphate, mucus.

3.Clinical validation ■ For the evaluation of diagnostic performance:COVID-19 positive samples from 120 individuals and COVID-19 negative samples from 192 individuals were tested for the presence of SARS-CoV-2 N antigen as part of validation by Rabi laboratories in Denver, CO 80207 USA. In addition, COVID-19 positive samples from 430 individuals and COVID-19 negative samples from 1290 individuals were tested for the presence of the SARS-CoV-2 N antigen as part of further validation by Medlifelab, Düzce Istanbul.

Method PCR Total Results Results Positive Negative

Positive 116 2 118 Negative 4 190 194

Total Result 120 192 312

Sensitivity: 96.66% (116/120)Specificity: 98.96% (190/192)

Method PCR Total Results Results Positive Negative

Positive Negative

Total Result

SensitivitySpecificity

419 9 42811 1281 1292

430 1290 1720

: 97,44% (419/430): 99,30% (1281/1290)

(95%CI 95.47% - 98.72%)(95%CI 98.68% - 99.68%)

(95%CI 91.69% - 99.08%)(95%CI 96.29% - 99.87%)

REFERENCEOn the True Number of COVID-19 Infections: Effect of Sensitivity, Specificity and Number of Tests on Prevalence Ratio Estimation.Altman E, Mounir I, Najid FZ, Perlaza SM.Int J Environ Res Public Health. 2020 Jul 24;17(15):5328. doi: 10.3390/i-jerph17155328. PMID: 32722110 Free PMC article.

Detecting the Coronavirus (COVID-19).Pokhrel P, Hu C, Mao H.ACS Sens. 2020 Aug 28;5(8):2283-2296. doi: 10.1021/acssensors.0c01153. Epub 2020 Jul 17.PMID: 32627534 Free PMC article.

INTERPRETATION OF THE RESULTSPositive (+): Two red lines appear. One is in the test area (T) and the other is in the quality control area (C). Negative (-): Only one red line appears in the quality control zone (C) and no line appears in the test area (T). Any appearance of the line in the test area (T) after the test time of maximum 15 min has no diagnostic relevance. Invalid: No red line appears in the quality control area (C). This indicates that the application went wrong or the test case is damaged.

LIMITATIONS The SARS-CoV-2 Antigen Rapid Test is designed for the primary detection of SARS-CoV-2 N antigen and is intended for use by professionals only. It is not suitable for home testing.

PERFORMANCE CHARACTERISTICS1. Analytical sensitivity/cross-reactivity.■ Limit of detection (LoD): 2.87 x 103TCID50/mL (heat-inactivated culture fluid). ■ Cross-reactivity: Cross-reactivity with SARS-CoV-1 is present,but no cross-reactivity with MERS coronavirus, human corona virus (NL63), human coronavirus (229E), human coronavirus(0C43), Human adenovirus type 1, Human adenovirus type 3, Human adenovirus type 8, Human adenovirus type 18, Human adenovirus type23, Human adenovi-rus type 7, Human adenovirus type 5, Human adenovirus type 11, Influenza A H1N1 WS/33, Influenza A H1N1 PDM-09,Influenza B Taiwan/2/62, Human para-influenza virus type 1, Human para-in-fluenza virus type 2, Human para-influenza virus type 3, Human para-influen-za virus type 4, Human rhinovirus type 1, Human rhinovi-rus type 14, Human rhinovirus type 42, Human metapneumovirus, Respiratory syncytial virus-A, Respiratory syncytial virus-B.

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SARSCoV-2

S

T

C

Wait 15 minutes to see the result

SA

RS

CoV

-2S

T C

Squeeze 2 drops (45-75 μL) of the sample material into the sample well (S) of the test cassette.

Kinking of the swab stick

Close the screw cap with the small stopper so that no sample solution escapes from the reagent tube.

Close the reagent tube with the screw cap. Leave on for at least 1 minute.

Minimum1 Minute

Stir at least 10 timesUncap the reagent tube

Make sure that the screw cap is screwed tightly. T

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Positive Negative

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Invalid

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Use only the cotton swab from the package

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ISO 15223 Symbols

This product fulfils the requirements of the Directive 98/79/EC on in vitro diagnostic medical device

Read instructions for use

Use by

Do not re- use

Do not use if package is damaged

Temperature limit

Keep away from sunlight

Contains sufficient for 25 tests

Batch code

In vitro diagnostic medical

Manufacturer

Date of manufacture

For Use by Qualified Personnel Only

Biohazade

Protect from moisture

25

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