_{^{SARS-CoV-2 (COVID-19) World’s Fastest Antigen Detection / Test Kit (Colloidal Gold)}} ​

 

【PRODUCT NAME】

  SARS-CoV-2 (COVID-19) Antigen Rapid Test Kit(Colloidal Gold)

 

 

【SPECIFICATION】

  1 test/kit;20 tests/kit; 25 tests/kit; 50 tests/kit.

 

 

【INTENDED USE】

This kit is intended to be used for the qualitative detection of SARS-CoV-2 antigen in human respiratory

specimens, sputum and other samples. This kit uses cellulose membrane immunochromatography technology.

Antigen detection is used for auxiliary diagnosis or epidemiological investigation of human infection

with SARS-CoV-2.

 

【PRINCIPLE】

The kit adopts cellulose membrane immunochromatography technology and applies the principle of

membrane chromatography double antibody sandwich method to detect the SARS-CoV-2 antigens in human

samples. The product consists of sample well and detection area on the Detection Strip. The Detection strip

contains coated anti-SARS-CoV-2 monoclonal antibody, colloidal gold particles labeled with anti-SARS-CoV-2

monoclonal antibody, and goat anti-mouse polyclonal antibody. When SARS-CoV-2 antigens are present

in the sample, the SARS-CoV-2 antigens will combine with the colloidal gold-labeled anti-SARS-CoV-2

monoclonal antibody, it will be captured by the coated anti-SARS-CoV-2 monoclonal antibody.

When the viral antigen crosses the T region of detection line, it will be captured by the coated anti-coronavirus

monoclonal antibody, which will gather and develop color in the detection area. Conversely, if SARS-CoV-2

antigens are not present in the sample or the antigen titer is below the limit of detection, there will be no color

band appearance on the detection line and the result will be negative. Regardless of whether the sample

contains antigens of the SARS-CoV-2, a color band should appear on the quality control region (C region)line

of the detection area. The quality control band is the standard for judging whether the inspection process is

normal and it also serves as the internal control standard for the Detection Strip.

 

【KIT COMPONENTS】

 

 

The materials and instruments necessary for the test but not provided are as follows:

Lancet;

Absorbent paper or similar material;

Timer;

Micro pipette corresponding to the range;

Laboratory safety protection equipment such as disposable gloves, etc.

 

【STORAGE CONDITIONS AND SHELF LIFE】

Stored at 2°C ~ 30°C, and kept away from direct sunlight.

The validity period is 12 months.

After the aluminum foil bag is opened, the Detection Strip should be used within 1 hour.

The Sample Diluent Buffer should be capped immediately after usage.

Usage after the date of expiration is not recommended.

Date of manufacture & expiration are indicated on the label and package.

 

【SAMPLE REQUIREMENTS】

Sample type: nasal swabs, throat swabs, deep cough sputum, respiratory tract extracts, bronchial lavage fluid,

alveolar lavage fluid, etc.

Sample collection: the collection and testing of patient samples must be performed in accordance with the

“Guidelines on Laboratory Testing Techniques for COVID-19 Caused by SARS-CoV-2” (The 4th edition)

released by the National Health Commission.

Sample processing :

1. Take 500 µL (deep cough sputum, respiratory tract extract, bronchial lavage fluid, alveolar lavage fluid)

from sample to be tested, mix it with 500 µL of sample diluent solution (1:1), and then take 100 µL into the

sample well for testing ;

 

2. Samples such as nasal swabs or throat swabs are directly put into 500 µL sample diluent solution, mixed

thoroughly, and then about 100 µL the supernatant is taken for testing.

 

Sample storage: the samples should be processed for testing in time after collection; if not, they should be

stored in accordance with the requirements of the “Guidelines on Laboratory Testing Techniques for

COVID-19 Caused by SARS-CoV-2” (The 4th edition) released by the National Health Commission.

 

Sample safety: all samples should be treated as potentially infectious materials and subject to the relevant

standards and guidelines.

 

【EXPERIMENT WORKFLOW】

Please read the instruction for use carefully before using this kit. All reagents should be incubated at room

temperature (10-30°C) for 30 minutes prior to use. The test should be carried out at room temperature and the

operation procedure is described below:

 

1. Open the sealed bag and remove the Detection Strip. Mark the sample ID on the test strip and lay the strip

flat on the table.

 

2. Specimen collection

 

    1). Carefully insert the swab into the nostril of the patient, reaching the surface of posterior nasopharynx,

          that presents the most secretion under visual inspection.

    2). Swab over the surface of the posterior nasopharynx. Rotate the swab several times.

    3). Withdraw the swab from the nasal cavity.

 

 

3.Sample preparation

 

    1).  Insert the sample diluent tube into the pipe rack, make sure that the tube is standing firm and reaches

          the bottom of the pipe rack.

    2). Open the purple cap of the sample diluent tube. Insert the swab into the diluent tube which contains

          0.5 mL of the diluent buffer. Roll the swab at least 6 times while pressing the head against the bottom

          and side of the diluent tube.

    3). Leave the swab in the diluent tube for 1 minute.

    4). Squeeze the tube several times with fingers from outside of the tube to immerse the swab. Remove

          the swab,close the cap. The diluent solution will be used as test sample.

    5). Open the small cap on the top of the sample dilution tube. Add 3-4 drops (~100 μL) of the sample

          diluent buffer immediately to the sample well.

    6). Allow the strip to develop for 10-15 minutes at room temperature. A visible band can be read by

          naked eyes.

 

 

【RESULTS ANALYSIS】

The interpretation of visual interpretation results (as shown below):

 

1. The results can be read directly by naked eyes as shown in the figures below: Positive result: a visible band

can be seen in both line C and line T.

2. Negative result: A visible band can be seen in line C only.

   

 

3. Invalid result: A visible band cannot be seen in line C, and the test must be repeated using a new strip.

    

 

 

【CUT-OFF VALUE】

1. Determination of the cut-off value, the product is a qualitative detection kit of antigens to the SARS-CoV-2.

When the quality control line (C line) and the test line (T line) are formed, regardless of a weak T line, as long

as it is visible to the normal naked eyes, the test result should be judged as positive.

2. The test for the normal population should be negative. Positive test results indicate that an individual may

have been exposed to SARS-CoV-2, and should be combined with clinical symptoms and other diagnostic

results for further confirmation.

 

【INTERPRETATION OF TEST RESULTS】

1. Common mistakes that may lead to false positive or negative results include: the kit is used after its

expiration; the kit has been improperly stored; the operating temperature is too low (<4°C) or too high

(>30°C); the procedures outlined in this protocol were not strictly adhered to.

2. Any final clinical interpretation should consider a combination of test results, clinical symptoms, and other

indicators.

 

【LIMITATIONS OF INSPECTION METHODS】

1. If the patient has clinical symptoms but the test result is negative , it is recommended to use PCR method for

confirmation and the doctor will make a comprehensive judgment to confirm the diagnosis. The negative

result cannot be the only evidence to rule out the SARS-CoV-2 infection.

2. The product can only be used for clinical diagnosis and on-site screening of the SARS-CoV-2. The positive

results of all Detection Strips must be confirmed by a qualified laboratory. Positive result of antigen

detection should be combined with other clinical features to ensure accurate diagnosis.

3. In order to ensure the accuracy of the SARS-CoV-2 antigens detection, high temperature and humidity must

be avoided.

 

【PERFORMANCE CHARACTERISTICS】

1. Coincidence rate of negative reference: test 15 SARS-CoV-2 antigen negative references with the kit.

Coincidence rate of 15 negative references should be 100%.

2. Coincidence rate of positive reference: test 5 SARS-CoV-2 antigen positive references with the kit.

Coincidence rate of 5 positive references should be 100%.

3. Limit of detection (LOD): test 3 LOD references with the kit. S1 can be positive or negative and S2~S3

should be positive.

4. Reproducibility: test 2 repeatable references R1 and R2 for 10 times with the kit, the results should be all

negative for R1 and positive for R2.

5. Inter-run variability: test 2 repeatable references R1 and R2 for 10 times with 3 batches of kits, the results

should be consistently and all negative for R1 and positive for R2.

 

【PRECAUTIONS】

1. This product is a disposable in vitro diagnostic reagent. Do not reuse. Do not use this kit if it is expired.

2. In order to obtain the correct test results, the test should be operated strictly according to the Instruction

    for Use.

3. The Detection Strips and Sample Diluent Buffer should be brought up to room temperature before use.

4. All test samples and waste should be treated as infectious and disposed of in accordance with local

    regulations.

5. The kit should be stored at 4-30℃.Do not freeze, avoid heavy pressure during storage and keep away

    from moisture, light and heat.

6. When transporting at room temperature, light handling, light loading and unloading, avoiding heavy

    pressure, waterproofing and high temperature resistance must be observed during transportation.

7. It is recommended to use fresh samples instead of repeated freeze-thaw samples. Pay attention to

    safety measures during operation, such as wearing protective clothing and gloves.

8. Desiccant is contained in the aluminum foil bag. Do not ingest.

 

【INDEX OF SYMBOL】

 

【AUTHORIZED REPRESENTATIVE】

 

Lotus NL B.V.

Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands.