Novel Coronavirus (COVID-19) Antigen Detection Kit
(Latex Immunochromatography )
For use with saliva specimen
For in vitro Diagnostic Use Only
For Covid-19 self-testing
Instruction for Use
【Product name】
Novel Coronavirus (COVID-19) Antigen Detection Kit (Latex Immunochromatography)
【Size】
1 test (GK820101), 5 tests (GK820105).
【Intended use】
This product is intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2. This self-test is for home use with self-collected saliva specimen directly from individuals who are suspected of Covid-19 during the beginning of the onset of symptoms.
Persons who test positive with this self-test should self-isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary and for public health reporting.
Negative results should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient management may be performed. Negative results do not rule out Covid-19 and should not be used as the sole basis for treatment or patient management decisions.
【Principle of test】
This kit uses latex immunochromatography and double antibody sandwich immunoassay to detect the novel coronavirus (COVID-19) antigen in human saliva specimen. Drip the sample to the designated area of the test card. By the chromatography effect, a reaction complex is formed when the novel coronavirus (COVID-19) antigen in the sample reacts with the latex microspheres labelled novel coronavirus (COVID-19) antibody on the binding pad. It moves forward along the nitrocellulose membrane. The detection line (T) shows red, should the complex be captured by the novel coronavirus (COVID-19) antibody immobilized on the nitrocellulose membrane detection line (T). Detection line (T) is not showing red colour when there is no binding occurs, should there is no novel coronavirus (COVID-19) antigen in the sample. The quality control line (C) should be displayed in red regardless of whether the test substance is contained in the tested sample. Otherwise, the test is considered as invalid.
【Main components】
- The main components of the test card: the test card is composed of a test strip shell and a test strip.
- The main components on the test strip are:
- Binding pad: contains latex microspheres labelled novel coronavirus (COVID 19) antibody.
- Nitrocellulose membrane: novel coronavirus (COVID-19) antibody and goat anti-mouse IgG antibody is fixed in the detection area and the quality control area, respectively.
- Sample pad
- Absorbent paper
- PVC bottom plate
No. | Items | 1 Test pack | 5 Tests pack |
1 | Test card（for one test） | 1 | 5 |
2 | Instruction for use | 1 | 1 |
3 | Sample extraction tube and dripper | 1 set | 5 sets |
4 | Sample extraction buffer | 1 | 5 |
5 | Swab | 1 | 5 |
6 | Saliva collector | 1 | 5 |
7 | Biohazard bag | 1 | 5 |
【Storage conditions & period of validity& lot number】
- The kit should be stored at 2℃~30℃ with 18 months validity.
- Avoid moisture, heat, and excessive force during storage.
- Lot number：
【Sample requirement】
Saliva specimen collection (see Figure 1)
①Do not eat, drink, smoke or chew gum within 30 minutes before specimen collection. Carefully open the kit and remove the funnel and collection tube. Spit the saliva through the funnel into the collection tube until about one-third of the tube. In order to enrich the saliva in the mouth, press the tip of the tongue against the top of the mouth;
②Keep the collection tube upright, and unscrew the funnel from the collection tube;
③Dip the swab into the collection tube and roll it until the swab is covered with a large amount of saliva.
Figure 1
【Test methods】
Please read this instruction carefully before use. Samples, reagents, and other required equipment should be used after
been rested to room temperature, In the environment of 60% or greater humidity, the kit should be used immediately
after opening the aluminium foil, otherwise use within one hour once package been opened.
1. Specimen extraction (see Figure 2)
(1). Add 1 Vial (350μL) sample extraction buffer to the extraction tube.
(2). Put the swab had collected specimen into the extraction tube, hold and press the swab head against the wall of tube with force while rotating the swab for about 10 times to release the antigen into the extraction solution from the swab head.
(3). Put the swab had collected specimen into the extraction tube, hold and press the swab head against the wall of tube with force while rotating the swab for about 10 times to release the antigen into the extraction solution from the swab head.
(4). Install the extraction tube cover to the extraction tube. The retained extract was taken for testing.
Figure 2
2. Testing procedures (see Figure 3)
(1). Open the aluminium foil bag and take out the test card lay flat.
(2). Drip 80μL (about 2~3 drops) of the processed sample extract to the sample hole of the test card.
(3). Read and interpret the test result at 15minutes, the test result should not be read and interpreted after 20 minutes.
Figure 3
【Interpretation of test results】 (see Figure 4)
Positive: There are one clear red bar on each of the test line (T) and the quality control line (C), which indicates the novel
coronavirus (COVID-19) antigen test is positive.
Negative: Only one clear red bar on the quality control line (C), which indicates the novel coronavirus (COVID-19) antigen
test is negative.
Invalid: There is no red bar on the quality control line (C), and the test is invalid regardless of whether there is a red bar on
the detection line (T).
Note: The colour saturation of the displayed results is related to the concentration of the tested substance in the extracted
sample. Regardless of the colour saturation, the result should be interpretated according to whether the red bar(s) is
displayed. This reagent contains a quality control process. A red bar must be presented on quality control line (C) to confirm the test result is valid.
If the test result is positive:
- There is a suspicion of COVID-19
- Contact your doctor / general practitioner or the local health department immediately
- Comply with the local guidelines for self-isolation
- Carry out a PCR confirmation test
In case of a negative test result:
- Continue to comply to all applicable rules regarding contact with others and -protective measures.
- Even with a test an infection may occur
- If suspected , repeat the test after 1-2 days as the COVID-19 infection cannot me accurately detected at all stages of infection
In the case of an invalid test result:
- Possibly caused by an incorrect test execution
- Repetition of the test
- If the test results are still invalid, contact a doctor or a COVID-19 test center.
Figure 4
【Limitations of inspection methods】
1. The accuracy of the test is great affected by the sample collection process. Improper sample collection and sample
storage, stale sample or repeated freezing and thawing of samples will affect the test results.
2. The test card only provides qualitative detection of the COVID-19 antigen in the sample. Should you need to test the
specific content of a certain index, please use relevant instruments.
3. Analysis of potential factors that cause the false negative results:
i. Improper sample collection, operation and processing, and low virus titre in the sample may lead to false negative
results.
ii. Various gene mutations may cause changes in antigenic determinants, resulting in false negative results. This type of
situation is more likely to occur with monoclonal antibody reagents.
【Product performance index】
1. Positive coincidence rate: 5 copies of the novel coronavirus (COVID-19) recombinant antigen reference material (P1~P5)
are tested, and the results should all be positive.
2. Negative coincidence rate: 5 copies of the novel coronavirus (COVID-19) recombinant antigen reference materials
(N1~N5) are tested, and the results should all be negative.
3. Minimum detection limit: 3 copies of the novel coronavirus (COVID-19) recombinant antigen reference material (L1~L3) should be tested. L1 should be negative, L2 and L3 should be positive.
4. Repeatability: Repeat the detection of the novel coronavirus (COVID-19) recombinant antigen reference (R) 10 times,
and the results should all be positive.
【Precautions】
1. This kit is for in vitro diagnostic use only.
2. The test card, sample extraction tube and dripper, swab and saliva collector are all disposable and cannot be reused.
3. Please check the integrity and expiry date of the kit package before use. The kit been stored in fridge should be restored
to ambient temperature prior opening the package. Kit with damaged package and/or the kit has passed expiry date
cannot be used.
- The components in the kits of different batch numbers are not interchangeable.
5. After the test card is taken out of the aluminium foil bag, the test should be carried out as soon as possible to avoid
leaving it in the air for prolonged time, which may contract moisture.
6. The optimal detection temperature is 15℃ ~ 30℃, with 40% ~ 60% relative humidity.
7. The desiccant in the aluminium foil bag is not edible.
8. Should no red bar show on the quality control line(C), the test deemed to be invalid.
9. Use a spray of household bleach (bleach) or a spray of 70% - 75% alcohol for kill germs used tools components.
10. Put all used tools into the biohazard bag and seal it well.
11. Wash hand with soap and water until clean.
【Approval Date and Revision Date of the Instruction for use】
Approval Date: 15 July 2020
Revision Date: 14 Dec 2021
Date of Issue: 14 Dec 2021
【Conditional Approval Letter Reference Number】
【Index of CE Symbols】
Zhejiang GENE SCIENCE Co., Ltd.
Address: No.2 workshop, pharmaceutical industrial park, No.11 Shengxing Road, Shangyu Economic and Technological Development zone, Hangzhou Bay, Shaoxing, Zhejiang,China.312300
Email:support@gene-science.com
Tel: 86-575-82963126
Post code: 312300
Authorised Representative in Malaysia:
Worldwide Business Ventures Sdn Bhd (1046832-X),
B1-16-3A, Soho Suite @ KLCC, 20,
Jalan Perak, 50450 Kuala Lumpur, Malaysia