rapid sars-cov-2 antigen test card information zur

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1 2 3 4 082137 / 210225

RAPID SARS-COV-2 ANTIGEN TEST CARD

INSTRUCTION GUIDE FOR ANTERIOR NASAL SWAB SPECIMENS For private use/home use/self-testing

Temporarily approved for self-testing according to §11 MPG in Germany until 24.05.2021 (BfArM

GZ: 5640-S-007/21) without completed conformity assessment procedure.

1N40C5-2 For 1 Test/Box 1N40C5-4 For 5 Tests/Box

1N40C5 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. 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

Sterilized 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

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. 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 oroparyngeal 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 dentification/confirmation of tissue culture isolates and should not be used in this capacity. PREPARATION Clear, clean and dry a flat surface. Check the test kit contents. Make sure that nothing is damaged or broken. Timer at hand. Blow your nose several times before collecting specimen. 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. Dispose of the used device according to your local regulations and biohazard waste disposal protocol.

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.

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 4°C

30°C

Store between 4- 30 °C

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. Authorized Representative:

Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands.

Distributor: Technomed Service, Planung, Handel mit medizinischen, techhnischen Geräten und Anlagen Gesellschaft m.b.H.. Stattegger Straße 31B, A-8045 Graz - Austria

Support Hotline Email: [email protected] Web: www.dein-corona-selbsttest.de

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See Instructions

for Use

Expiry Date

Tests per Kit

Keep dry

Batch Number



Manufacturer

Do not reuse


30°C


Catalogue Number


Manufacturer:







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See Instructions

for Use

Expiry Date

Tests per Kit

Keep dry

Batch Number



Manufacturer

Do not reuse


30°C


Catalogue Number


Manufacturer:







1

2

3

4

08

2137

/ 2

1022

5

RA

PID

SA

RS-

CO

V-2

AN

TIG

EN T

EST

CA

RD

INST

RUCT

ION

GUI

DE F

OR

ANTE

RIO

R NA

SAL

SWAB

SPE

CIM

ENS

For p

rivat

e us

e/ho

me

use/

self-

test

ing

Te

mpo

raril

y ap

prov

ed fo

r sel

f-tes

ting

acco

rdin

g to

§11

MPG

in G

erm

any

until

24.

05.2

021

(BfA

rM

GZ:

564

0-S-

007/

21) w

ithou

t com

plet

ed c

onfo

rmity

ass

essm

ent p

roce

dure

.

1N

40C5

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For 1

Tes

t/Box

1N40

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Fo

r 5 T

ests

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Fo

r 20

Test

s/Bo

x

Pl

ease

follo

w th

e in

stru

ctio

n le

afle

t car

eful

ly.

INTE

NDED

USE

R

apid

SAR

S-C

oV-2

Ant

igen

Tes

t Car

d is

an

imm

unoc

hrom

atog

raph

y ba

sed

one

step

in v

itro

test

. It i

s de

sign

ed f

or t

he r

apid

qua

litat

ive

dete

rmin

atio

n of

SAR

S-C

oV-2

viru

s an

tigen

in a

nter

ior

nasa

l sw

abs

from

in

divi

dual

s su

spec

ted

of

CO

VID

-19

with

in

the

first

se

ven

days

of

sy

mpt

om

onse

t. R

apid

SA

RS-

CoV

-2 A

ntig

en T

est C

ard

shal

l not

be

used

as

sole

bas

is to

dia

gnos

e or

exc

lude

SAR

S-C

oV-2

in

fect

ion.

SU

MM

ARY

The

nove

l cor

onav

iruse

s be

long

to t

he β

gen

us.

CO

VID

-19

is a

n ac

ute

resp

irato

ry in

fect

ious

dis

ease

. Pe

ople

are

gen

eral

ly s

usce

ptib

le. C

urre

ntly

, the

pat

ient

s in

fect

ed b

y th

e no

vel c

oron

aviru

s ar

e th

e m

ain

sour

ce o

f inf

ectio

n, a

sym

ptom

atic

infe

cted

peo

ple

can

also

be

an in

fect

ious

sou

rce.

Bas

ed o

n th

e cu

rrent

ep

idem

iolo

gica

l in

vest

igat

ion,

the

inc

ubat

ion

perio

d is

1 t

o 14

day

s, m

ostly

3 t

o 7

days

. Th

e m

ain

man

ifest

atio

ns in

clud

e fe

ver,

fatig

ue a

nd d

ry c

ough

. Nas

al c

onge

stio

n, ru

nny

nose

, sor

e th

roat

, mya

lgia

an

d di

arrh

ea a

re fo

und

in a

few

cas

es.

MAT

ERIA

LS P

ROVI

DED

Com

pone

nts

For 1

Tes

t/Box

Fo

r 5 T

ests

/Box

Fo

r 20

Test

s/Bo

x R

apid

SAR

S-C

oV-2

Ant

igen

Tes

t Car

d (s

eale

d fo

il po

uch)

1

5 20

Ster

ilized

sw

ab

1 5

20

Extra

ctio

n tu

be

1 5

20

Sam

ple

extra

ctio

n bu

ffer

1 5

20

Inst

ruct

ions

for u

se (t

his

leaf

let)

1 1

1 Tu

be s

tand

1

(pac

kagi

ng)

1 1

IMPO

RTAN

T IN

FORM

ATIO

N BE

FORE

THE

EXE

CUTI

ON

1. R

ead

this

inst

ruct

ion

guid

e ca

refu

lly.

2. D

o no

t use

the

prod

uct b

eyon

d th

e ex

pira

tion

date

. 3.

Do

not u

se th

e pr

oduc

t if t

he p

ouch

is d

amag

ed o

r the

sea

l is

brok

en.

4. S

tore

the

test

dev

ice

at 4

to 3

0°C

in th

e or

igin

al s

eale

d po

uch.

Do

Not

Fre

eze.

5.

The

pro

duct

sho

uld

be u

sed

at ro

om te

mpe

ratu

re (1

5°C

to 3

0°C

). If

the

prod

uct h

as b

een

stor

ed in

a

cool

are

a (le

ss th

an 1

5°C

), le

ave

it at

nor

mal

room

tem

pera

ture

for 3

0 m

inut

es b

efor

e us

ing.

6.

Han

dle

all s

peci

men

s as

pot

entia

lly in

fect

ious

. 7.

Ina

dequ

ate

or i

napp

ropr

iate

spe

cim

en c

olle

ctio

n, s

tora

ge,

and

trans

port

may

yie

ld i

nacc

urat

e te

st

resu

lts.

8. U

se th

e sw

abs

incl

uded

in th

e te

st k

it to

ens

ure

optim

al p

erfo

rman

ce o

f the

test

. 9.

Cor

rect

spe

cim

en c

olle

ctio

n is

the

mos

t im

porta

nt s

tep

in th

e pr

oced

ure.

Mak

e su

re to

col

lect

eno

ugh

spec

imen

mat

eria

l (na

sal s

ecre

tion)

with

the

swab

, esp

ecia

lly fo

r ant

erio

r nas

al s

ampl

ing.

10

. Blo

w th

e no

se s

ever

al ti

mes

bef

ore

colle

ctin

g sp

ecim

en.

11. T

he s

peci

men

s sh

ould

be

test

ed a

s so

on a

s po

ssib

le a

fter c

olle

ctio

n.

12. A

pply

the

drop

s of

test

spe

cim

en o

nly

to th

e sp

ecim

en w

ell (

S).

13. T

oo m

any

or to

o fe

w d

rops

of e

xtra

ctio

n so

lutio

n ca

n le

ad to

an

inva

lid o

r inc

orre

ct te

st re

sult.

14

. Chi

ldre

n un

der 1

4 ye

ars

of a

ge s

houl

d be

ass

iste

d by

an

adul

t. LI

MIT

ATIO

NS

1. T

he te

st is

to b

e us

ed e

xclu

sive

ly fo

r the

qua

litat

ive

dete

ctio

n of

SAR

S-C

oV-2

vira

l ant

igen

in a

nter

ior

nasa

l sw

ab s

peci

men

s. T

he e

xact

con

cent

ratio

n of

SAR

S-C

oV-2

vira

l ant

igen

can

not b

e de

term

ined

as

part

of th

is te

st.

2.

Pro

per

spec

imen

col

lect

ion

is c

ritic

al.

Failu

re t

o fo

llow

the

pro

cedu

re m

ay r

esul

t in

inac

cura

te t

est

resu

lts. I

mpr

oper

col

lect

ion,

sto

rage

, or e

ven

freez

ing

and

thaw

ing

of th

e sp

ecim

en c

an le

ad to

inac

cura

te

test

resu

lts.

3. If

the

vira

l loa

d of

the

spec

imen

is b

elow

the

dete

ctio

n lim

it of

the

test

, the

test

may

pro

duce

a n

egat

ive

resu

lt.

4. A

s w

ith a

ll di

agno

stic

test

s, a

def

initi

ve c

linic

al d

iagn

osis

sho

uld

not b

e ba

sed

on th

e re

sult

of a

sin

gle

test

, but

sho

uld

be m

ade

by th

e ph

ysic

ian

afte

r eva

luat

ion

of a

ll cl

inic

al a

nd la

bora

tory

resu

lts.

5. A

neg

ativ

e re

sult

does

not

exc

lude

vira

l inf

ectio

n ex

cept

for S

ARS

-CoV

-2 a

nd s

houl

d be

con

firm

ed b

y m

olec

ular

dia

gnos

tic m

etho

ds if

CO

VID

-19

is s

uspe

cted

.

6. A

pos

itive

resu

lt do

es n

ot e

xclu

de c

oinf

ectio

n w

ith o

ther

pat

hoge

ns.

7.

The

SAR

S-C

oV-2

rapi

d an

tigen

test

can

det

ect b

oth

viab

le a

nd n

on-v

iabl

e SA

RS-

CoV

-2 m

ater

ial.

The

perfo

rman

ce o

f the

SAR

SCoV

-2 r

apid

test

is d

epen

dent

on

vira

l loa

d an

d m

ay n

ot c

orre

late

with

oth

er

diag

nost

ic m

etho

ds p

erfo

rmed

on

the

sam

e sp

ecim

en.

8. U

sers

sho

uld

test

spe

cim

ens

as s

oon

as p

ossi

ble

afte

r sp

ecim

en c

olle

ctio

n an

d w

ithin

two

hour

s of

sp

ecim

en c

olle

ctio

n.

9. S

ensi

tivity

for

nas

al o

r or

opar

ynge

al s

wab

s m

ay b

e lo

wer

tha

n na

soph

aryn

geal

sw

abs.

It

is

reco

mm

ende

d to

use

the

naso

phar

ynge

al s

wab

spe

cim

ens

by h

ealth

care

pro

fess

iona

ls.

10.

Mon

oclo

nal a

ntib

odie

s m

ay fa

il to

det

ect,

or d

etec

t w

ith le

ss s

ensi

tivity

, SA

RS-

CoV

-2 v

iruse

s th

at

have

und

ergo

ne m

inor

am

ino

acid

cha

nges

in th

e ta

rget

epi

tope

regi

on.

11. T

he a

mou

nt o

f ant

igen

in a

sam

ple

may

dec

reas

e as

the

dura

tion

of il

lnes

s in

crea

ses.

Spe

cim

ens

colle

cted

afte

r day

5-7

of i

llnes

s ar

e m

ore

likel

y to

be

test

ed n

egat

ive

com

pare

d to

a R

T-PC

R a

ssay

. 12

. The

kit

was

val

idat

ed w

ith th

e as

sorte

d sw

abs.

Use

of a

ltern

ativ

e sw

abs

may

resu

lt in

fals

e ne

gativ

e re

sults

. 13

. Th

e va

lidity

of

R

apid

SA

RS-

CoV

-2

Antig

en

Test

C

ard

has

not

been

pr

oven

fo

r de

ntifi

catio

n/co

nfirm

atio

n of

tiss

ue c

ultu

re is

olat

es a

nd s

houl

d no

t be

used

in th

is c

apac

ity.

PREP

ARAT

ION

Cle

ar, c

lean

and

dry

a fl

at s

urfa

ce.

C

heck

the

test

kit

cont

ents

. Mak

e su

re th

at n

othi

ng is

dam

aged

or b

roke

n.

Tim

er a

t han

d.

Blow

you

r nos

e se

vera

l tim

es b

efor

e co

llect

ing

spec

imen

.

W

ash

hand

s.

DISP

OSA

L Th

e te

st k

it m

ay b

e di

spos

ed o

f with

nor

mal

hou

seho

ld w

aste

in a

ccor

danc

e w

ith t

he a

pplic

able

loca

l re

gula

tions

. PR

OC

EDUR

E Th

is te

st is

sui

tabl

e fo

r peo

ple

of a

ll ag

es. T

he re

com

men

ded

oper

ator

s ar

e ag

ing

from

14

to 9

0. C

hild

ren

unde

r 14

year

s of

age

sho

uld

be te

sted

by

an a

dult.

Do

not c

ontin

ue th

e te

st if

the

child

feel

s an

y pa

in.

1

Rot

ate

the

lid o

f sam

ple

extra

ctio

n bu

ffer b

ottle

. Ca

utio

n: O

pen

it aw

ay fr

om y

our f

ace

and

be c

aref

ul

not t

o sp

ill an

y of

the

liqui

d.

2

Sque

eze

all e

xtra

ctio

n bu

ffer o

ut o

f the

bot

tle in

to th

e ex

tract

ion

tube

. Ca

utio

n: A

void

touc

hing

the

bottl

e ag

ains

t the

tube

.

3

Find

the

swab

in th

e se

aled

wra

pper

in fr

ont o

f you

. Id

entif

y th

e so

ft, fa

bric

tip

of th

e sw

ab.

4

Peel

ope

n th

e sw

ab p

acka

ging

and

gen

tly ta

ke o

ut

the

swab

. Ca

utio

n: N

ever

touc

h th

e so

ft, fa

bric

tip

of th

e sw

ab

with

you

r han

ds.

5

Car

eful

ly in

sert

swab

into

one

nos

tril.

The

swab

tip

shou

ld b

e in

serte

d no

less

than

2.5

cm

(1 in

ch) f

rom

th

e ed

ge o

f the

nos

tril.

Rol

l sw

ab 3

-4 ti

mes

alo

ng th

e m

ucos

a in

side

the

nost

ril. L

eave

sw

ab in

the

nost

ril fo

r se

vera

l sec

onds

. Usi

ng th

e sa

me

swab

, rep

eat t

his

proc

ess

for t

he o

ther

nos

tril.

With

draw

sw

ab fr

om th

e na

sal c

avity

. Ca

utio

n: T

his

may

feel

unc

omfo

rtabl

e. D

o no

t ins

ert

the

swab

any

dee

per i

f you

feel

stro

ng re

sist

ance

or

pain

.

6

Plac

e sw

ab in

to e

xtra

ctio

n tu

be. R

oll s

wab

thre

e to

five

(3

-5) t

imes

. Lea

ve s

wab

in e

xtra

ctio

n bu

ffer f

or 1

m

inut

e.

7

Pinc

h ex

tract

ion

tube

with

fing

ers

and

rem

ove

the

solu

tion

from

sw

ab a

s m

uch

as p

ossi

ble.

8

Inst

all t

he n

ozzl

e ca

p on

to th

e sa

mpl

e ex

tract

ion

tube

tig

htly

.

9

Brin

g th

e ki

t com

pone

nts

to ro

om te

mpe

ratu

re b

efor

e te

stin

g. O

pen

the

pouc

h an

d re

mov

e th

e ca

rd. P

lace

th

e ca

rd o

n a

flat a

nd le

vel s

urfa

ce.

Cau

tion:

Onc

e op

ened

, the

test

car

d m

ust b

e us

ed

imm

edia

tely

.

10

Inve

rt th

e ex

tract

ion

tube

and

add

3 d

rops

(abo

ut 7

5 μL

) of t

est s

peci

men

into

the

spec

imen

wel

l (S)

by

gent

ly s

quee

zing

the

extra

ctio

n tu

be.

Cau

tion:

Th

e fo

rmat

ion

of

air

bubb

les

in

the

spec

imen

wel

l (S)

mus

t be

avoi

ded.

11

Rea

d th

e re

sults

at 1

5-20

min

utes

. C

autio

n: R

esul

ts a

fter

20 m

inut

es m

ay n

ot b

e ac

cura

te.

Dis

pose

of t

he u

sed

devi

ce a

ccor

ding

to y

our l

ocal

re

gula

tions

and

bio

haza

rd w

aste

dis

posa

l pro

toco

l. IN

TERP

RET

ATIO

N O

F RE

SULT

S

Posi

tive:

If

two

colo

red

band

s ap

pear

with

one

col

ored

ban

d in

the

Con

trol Z

one

(C)

and

anot

her i

n th

e Te

st Z

one

(T) w

ithin

15-

20 m

inut

es, t

he te

st re

sult

is

posi

tive.

C

autio

n: N

o m

atte

r how

fain

t the

col

ored

ban

d is

in th

e Te

st Z

one

(T),

the

resu

lt sh

ould

be

cons

ider

ed a

s po

sitiv

e.

Neg

ativ

e:

If on

e co

lore

d ba

nd a

ppea

rs in

the

Con

trol Z

one

(C) a

nd n

o co

lore

d ba

nd

appe

ars

in th

e Te

st Z

one

(T) w

ithin

15-

20 m

inut

es, t

he te

st re

sult

is

nega

tive.

Inva

lid:

If no

col

or li

ne a

ppea

rs in

the

cont

rol a

rea

(C) w

ithin

15-

20 m

inut

es, t

he te

st

is in

valid

. Rep

eat t

he te

st w

ith a

new

test

car

d.

QU

ALI

TY C

ONT

RO

L Th

e co

ntro

l lin

e is

an

inte

grat

ed re

agen

t and

is u

sed

to c

ontro

l the

pro

cedu

re. T

he c

ontro

l lin

e ap

pear

s w

hen

the

test

has

bee

n pe

rform

ed c

orre

ctly

and

the

reag

ents

are

reac

tive.

FR

EQU

ENTL

Y A

SKED

QU

ESTI

ON

S (F

AQ

) 1.

H

ow d

oes

the

dete

ctio

n w

ork?

Th

e N

pro

tein

of t

he S

ARS-

CoV

-2 v

irus

reac

ts w

ith t

he s

tripe

-like

coa

ting

of t

he t

est

line

and,

if

pres

ent,

resu

lts in

a c

olor

cha

nge,

i.e.

a re

d lin

e ap

pear

s. T

here

fore

, if t

he s

ampl

e do

es n

ot c

onta

in

any

vira

l pro

tein

s or

ant

igen

s, th

ere

will

be n

o re

d te

st li

ne (T

).

2.

Whe

n sh

ould

/can

I te

st m

ysel

f?

You

can

test

you

rsel

f whe

ther

you

hav

e sy

mpt

oms

or n

ot. S

tudi

es s

how

that

ear

lier t

estin

g w

ithin

th

e fir

st 4

day

s of

illn

ess

typi

cally

mea

ns a

hig

her v

iral l

oad,

whi

ch is

eas

ier t

o de

tect

. Sin

ce th

e te

st

resu

lt is

a s

naps

hot v

alid

for t

hat p

oint

in ti

me,

test

ing

shou

ld b

e re

peat

ed a

s re

com

men

ded

by lo

cal

auth

oriti

es.

3.

W

hat c

an a

ffect

my

test

resu

lt? W

hat s

houl

d I p

ay a

ttent

ion

to?

Be s

ure

to b

low

you

r nos

e m

ultip

le ti

mes

bef

ore

colle

ctin

g th

e sp

ecim

en.

Be s

ure

to v

isib

ly c

olle

ct s

ampl

e m

ater

ial (

nasa

l sec

retio

ns).

Perfo

rm th

e te

st im

med

iate

ly a

fter t

akin

g th

e sa

mpl

e.

Follo

w th

e in

stru

ctio

ns fo

r use

car

eful

ly.

Appl

y th

e dr

ops

of e

xtra

ctio

n so

lutio

n on

ly to

the

sam

ple

wel

l (S)

To

o m

any

or to

o fe

w d

rops

of e

xtra

ctio

n so

lutio

n ca

n le

ad to

an

inva

lid o

r inc

orre

ct te

st re

sult.

4.

The

test

str

ip is

cle

arly

dis

colo

red

or s

mud

ged?

Wha

t is

the

reas

on fo

r thi

s?

Plea

se n

ote

that

the

test

car

d sh

ould

not

be

used

with

mor

e th

an 3

dro

ps o

f sam

ple,

as

the

liqui

d ab

sorp

tion

of th

e te

st s

trip

is n

atur

ally

lim

ited.

If th

e co

ntro

l lin

e do

es n

ot a

ppea

r or t

he te

st s

trip

is

badl

y sm

udge

d or

dis

colo

red,

mak

ing

it un

read

able

, pl

ease

rep

eat

the

test

acc

ordi

ng t

o th

e in

stru

ctio

ns.

5.

I h

ave

take

n th

e te

st, b

ut I

don’

t see

a c

ontro

l lin

e (C

). W

hat s

houl

d I d

o?

Your

test

res

ult i

s in

valid

. Obs

erve

the

answ

er to

que

stio

n 4

and

repe

at th

e te

st a

ccor

ding

to th

e in

stru

ctio

ns fo

r use

.

6.

I am

uns

ure

abou

t rea

ding

the

resu

lt. W

hat s

houl

d I d

o?

For t

he re

sult

to b

e po

sitiv

e, 2

stra

ight

hor

izon

tal l

ines

mus

t be

clea

rly v

isib

le w

ith th

e fu

ll w

idth

of

the

cass

ette

. If y

ou a

re s

till u

nsur

e ab

out t

he re

sults

, con

tact

the

near

est h

ealth

faci

lity

acco

rdin

g to

th

e re

com

men

datio

ns o

f you

r loc

al a

utho

ritie

s.

7.

M

y re

sult

is p

ositi

ve. W

hat s

houl

d I d

o?

If yo

ur re

sult

is p

ositi

ve a

nd th

e te

st k

it th

us c

lear

ly in

dica

tes

the

cont

rol l

ine

as w

ell a

s th

e te

st li

ne,

you

shou

ld c

onta

ct th

e ne

ares

t med

ical

faci

lity

as re

com

men

ded

by y

our l

ocal

aut

horit

ies.

You

r tes

t re

sult

may

be

doub

le-c

heck

ed a

nd th

e au

thor

ity o

r fac

ility

will

expl

ain

the

appr

opria

te n

ext s

teps

.

8.

My

resu

lt is

neg

ativ

e. W

hat s

houl

d I d

o?

If th

e te

st k

it on

ly c

lear

ly s

how

s th

e co

ntro

l lin

e, th

is m

ay m

ean

that

you

are

neg

ativ

e or

that

the

vira

l lo

ad is

too

low

to

be d

etec

ted.

If

you

expe

rienc

e sy

mpt

oms

(hea

dach

e, f

ever

, m

igra

ine,

loss

of

sens

e of

sm

ell o

r tas

te, e

tc.),

ple

ase

cons

ult y

our p

rimar

y ca

re p

hysi

cian

, or t

he n

eare

st h

ealth

car

e fa

cilit

y as

reco

mm

ende

d by

you

r loc

al a

utho

ritie

s.

If yo

u ar

e no

t sur

e, y

ou c

an re

peat

the

test

. 9.

Ho

w c

an I

disp

ose

of th

e pr

oduc

t?

The

test

kit

may

be

disp

osed

of w

ith n

orm

al h

ouse

hold

was

te in

acc

orda

nce

with

the

appl

icab

le

loca

l reg

ulat

ions

.

EXPL

ANAT

ION

FOR

SYM

BOLS

In V

itro

Dia

gnos

tics

Use

See

Inst

ruct

ions

fo

r Use

Expi

ry D

ate

Test

s pe

r Kit

Keep

dry

Batc

h N

umbe

r

Auth

oriz

ed

Rep

rese

ntat

ive

Keep

aw

ay

from

sun

light

Man

ufac

ture

r

Do

not r

euse

Do

not u

se if

pa

ckag

e is

da

mag

ed

4°C

30°C

Stor

e be

twee

n 4-

30

°C

C

atal

ogue

N

umbe

r

War

ning

, ple

ase

refe

r to

the

inst

ruct

ion

Man

ufac

ture

r:

Xiam

en B

oson

Bio

tech

Co.

, Ltd

.

90-9

4 Ti

anfe

ng R

oad,

Jim

ei N

orth

Indu

stria

l Par

k,

Xiam

en, F

ujia

n, 3

6102

1, P

.R.C

hina

.

A

utho

rized

R

epre

sent

ativ

e:

Lotu

s N

L B.

V.

Koni

ngin

Jul

iana

plei

n 10

, 1e

Verd

, 259

5AA,

Th

e H

ague

, Net

herla

nds.

Dis

trib

utor

: Te

chno

med

S

ervi

ce,

Plan

ung,

H

ande

l m

it m

ediz

inis

chen

, te

chhn

isch

en

Ger

äten

und

Anl

agen

Ges

ells

chaf

t m.b

.H..

Stat

tegg

er S

traße

31B

, A-8

045

Gra

z - A

ustri

a

Su

ppor

t Hot

line

Emai

l: su

ppor

t@de

in-c

oron

a-se

lbst

test

.de

Web

: ww

w.d

ein-

coro

na-s

elbs

ttest

.de

1 2 3 4 082137 / 210225












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See Instructions

for Use

Expiry Date

Tests per Kit

Keep dry

Batch Number



Manufacturer

Do not reuse


30°C


Catalogue Number


Manufacturer:







1 2 3 4 082137 / 210225












2


3


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6


7


8


9


10


11




















See Instructions

for Use

Expiry Date

Tests per Kit

Keep dry

Batch Number



Manufacturer

Do not reuse


30°C


Catalogue Number


Manufacturer:







1 2 3 4 082137 / 210225












2


3


4



6


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8


9


10


11




















See Instructions

for Use

Expiry Date

Tests per Kit

Keep dry

Batch Number



Manufacturer

Do not reuse


30°C


Catalogue Number


Manufacturer:







Quelle: Beipackzettel zu den Corona-Schnelltests des Herstellers Xiamen Boson Biotech Co., Ltd.

NiedersächsischesKultusministerium

Information zur Anwendung der SelbsttestsXiamen Boson Biotech – Rapid SARS-CoV-2 Antigen Test

Anleitung Schnäuzen Sie vor der Probenentnahme mehrmals die Nase und waschen Sie sich anschließend die Hände.Extraktionsröhrchen in den Röhrchenständer der Verpackung drücken.

1. Öffnen Sie die Extraktionslösung. VORSICHT: Öffnen Sie es vom Gesicht weg und achten Sie darauf, dass Sie nichts von der Flüssigkeit verschütten.

2. Drücken Sie den gesamten Inhalt der Extraktionslösung in das Extraktionsröhrchen. VORSICHT: Vermeiden Sie den Kontakt der beiden Behälter. Achten Sie darauf, dass der Behälter nicht umfällt.

3. Finden Sie den Tupfer in der versiegelten Verpackung vor sich. Identifi zieren Sie die weiche, textile Spitze des Tupfers, die nicht mit den Händen berührt werden darf.

4. Ziehen Sie die Tupferverpackung auf und nehmen Sie den Tupfer vorsichtig heraus. VORSICHT: Versuchen Sie, die weiche, textile Spitze des Tupfers nicht mit den Händen zu berühren.

5. Führen Sie den Tupfer vorsichtig in ein Nasenloch ein. Die Tupferspitze sollte bis zu 2,5 cm tief vom Rand des Nasenlochs eingeführt werden. Drehen Sie entlang der Schleimhaut im Nasenloch, um sicherzustellen, dass sowohl Schleim als auch Zellen gesammelt werden. Drehen Sie den Tupfer 3-4 Mal. Belassen Sie den Abstrichtupfer einige Sekunden im Nasenloch. Wiederholen Sie den Vorgang mit demselben Tupfer im anderen Nasenloch. VORSICHT: Dies kann sich unangenehm anfühlen. Führen Sie den Tupfer nicht tiefer ein, wenn Sie starken Widerstand oder Schmerzen spüren.

6. Führen Sie den Abstrichtupfer mit der Probe in das Extraktionsröhrchen ein. Drehen Sie den Tupfer nun drei bis fünf (3-5) mal. Belassen Sie den Abstrich 1 Minute im Extraktionspuffer.

Stand 16.03.2021

Seite 2Quelle: Beipackzettel zu den Corona-Schnelltests des Herstellers Xiamen Boson Biotech Co., Ltd.

1 2 3 4 082137 / 210225












2


3


4



6


7


8


9


10


11




















See Instructions

for Use

Expiry Date

Tests per Kit

Keep dry

Batch Number



Manufacturer

Do not reuse


30°C


Catalogue Number


Manufacturer:







1 2 3 4 082137 / 210225












2


3


4



6


7


8


9


10


11




















See Instructions

for Use

Expiry Date

Tests per Kit

Keep dry

Batch Number



Manufacturer

Do not reuse


30°C


Catalogue Number


Manufacturer:







1 2 3 4 082137 / 210225












2


3


4



6


7


8


9


10


11




















See Instructions

for Use

Expiry Date

Tests per Kit

Keep dry

Batch Number



Manufacturer

Do not reuse


30°C


Catalogue Number


Manufacturer:







1 2 3 4 082137 / 210225












2


3


4



6


7


8


9


10


11




















See Instructions

for Use

Expiry Date

Tests per Kit

Keep dry

Batch Number



Manufacturer

Do not reuse


30°C


Catalogue Number


Manufacturer:







1 2 3 4 082137 / 210225












2


3


4



6


7


8


9


10


11




















See Instructions

for Use

Expiry Date

Tests per Kit

Keep dry

Batch Number



Manufacturer

Do not reuse


30°C


Catalogue Number


Manufacturer:







1 2 3 4 082137 / 210225












2


3


4



6


7


8


9


10


11




















See Instructions

for Use

Expiry Date

Tests per Kit

Keep dry

Batch Number



Manufacturer

Do not reuse


30°C


Catalogue Number


Manufacturer:







1 2 3 4 082137 / 210225












2


3


4



6


7


8


9


10


11




















See Instructions

for Use

Expiry Date

Tests per Kit

Keep dry

Batch Number



Manufacturer

Do not reuse


30°C


Catalogue Number


Manufacturer:







1 2 3 4 082137 / 210225












2


3


4



6


7


8


9


10


11




















See Instructions

for Use

Expiry Date

Tests per Kit

Keep dry

Batch Number



Manufacturer

Do not reuse


30°C


Catalogue Number


Manufacturer:







NiedersächsischesKultusministeriumNiedersächsischesKultusministerium

7. Drücken Sie das Extraktionsröhrchen mit den Fingern zusammen und entfernen danach so gut wie möglich die Lösung vom Abstrichtupfer, während Sie den Abstrichtupfer herausziehen und auf ein Einwegtuch legen.

8. Setzen Sie die Abdeckkappe mit Tropfaufsatz auf das Extraktionsröhrchen.

9. Öffnen Sie den Beutel und entnehmen Sie die Testkassette. Legen Sie die Testkassette auf eine fl ache und ebene Oberfl äche. VORSICHT: Nach dem Öffnen muss die Testkassette sofort verwendet werden.

10. Drehen Sie das Extraktionsröhrchen um und geben Sie 3 Tropfen (75 µl) der Testprobe auf die Probenvertiefung (S), indem Sie das Extraktionsröhrchen leicht andrücken. VORSICHT: Die Bildung von Luftblasen in der Probenvertiefung (S) ist zu vermeiden.

11. Das Ergebnis wird nach 15-20 Minuten angezeigt. VORSICHT: Nach über 20 Minuten kann das Ergebnis verfälschen.

Deutung der Testergebnisse

Positiv: Wenn innerhalb von 15-20 Minuten zwei Farblinien – eine Farblinie im Kontrollbereich (C) und eine Farblinie im Testbereich (T) – erscheinen, so ist der Test gültig und positiv. Das Ergebnis ist als positiv zu werten, egal wie schwach die Farblinie im Testbereich (T) zu sehen ist. Ein positives Ergebnis schließt eine gleichzeitige Infektion mit anderen Krankheitserregern nicht aus.

Negativ: Wenn innerhalb von 15-20 Minuten eine Farblinie im Kontrollbereich (C) erscheint, jedoch im Testbereich (T) keine Farblinie zu sehen ist, so ist der Test gültig und negativ. Ein negatives Ergebnis schließt eine virale Infektion mit SARS-CoV-2 nicht aus und sollte bei Verdacht von COVID-19 durch molekulardiagnostische Methoden bestätigt werden.

Ungültig: Wenn innerhalb von 15-20 Minuten keine Farblinie im Kontrollbereich (C) erscheint, so ist der Test ungültig. Wiederholen Sie den Test mit einer neuen Testkassette.

Seite 3

Erste-Hilfe-Maßnahmen Das Test-Kit und die Flüssigkeit enthalten chemisch reaktive Stoffe, die beim Verschütten oder Verspritzen Beeinträchtigungen der Gesundheit hervorrufen können.

Nach Hautkontakt Waschen Sie die Haut mit Wasser ab – sofern Irritationen oder Unwohlsein auftreten, konsultieren Sie einen Arzt/eine Ärztin.

Nach Augenkontakt Bei Berührung mit den Augen sofort gründlich mit viel Wasser spülen. Kontaktlinsen entfernen. Unverletztes Auge schützen. Auge weit geöffnet halten beim Spülen. Bei anhaltender Augenreizung einen Facharzt aufsuchen.

Bei Schlucken / Einnehmen Waschen Sie den Mund mit Wasser aus – sofern Irritationen oder Unwohlsein auftreten, konsultieren Sie einen Arzt/eine Ärztin.

Erste-Hilfe-Maßnahmen

Quelle: Beipackzettel zu den Corona-Schnelltests des Herstellers Xiamen Boson Biotech Co., Ltd.

NiedersächsischesKultusministeriumNiedersächsischesKultusministerium

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