A blue Antigen Fast Test Kit 5 boxes packing

【PRODUCT NAME】

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

【SPECIFICATION】

25 tests/kit,5 boxes into a big box.

【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.

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.

【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.

【INDEX OF SYMBOL】

【AUTHORIZED REPRESENTATIVE】

Lotus NL B.V.

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