OEM Antigen Rapid Test Home Kit
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【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.
|
Components
|
1T | 20T | 25T | 50T |
| 1. SARS-CoV-2 test card | 1 PIECE | 20 PIECES | 25 PIECES | 50 PIECES |
| 2. Disposable sampling tube(with sample diluent buffer) | 1 PIECE | 20 PIECES | 25 PIECES | 50 PIECES |
| 3. Disposable sampler | 1 PIECE | 20 PIECES | 25 PIECES | 50 PIECES |
| 4. Instructions | 1 COPY | 1 COPY | 1 COPY | 1 COPY |
Note: The components in the kits of different batch numbers are not interchangeable.
The materials and instruments necessary for the test but not provided are as follows:
Lancet;
Absorbent paper or similar material;
Timer;
Micropipette corresponding to the range;
Laboratory safety protection equipment such as disposable gloves, etc.
【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.
【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.
【EXPORTER】
Magnus Internationa Limited
F12, New City Internationa Mansion A, 234 Huapao Ave.
Liuyang, Hunan Province 410300 China
Contact: Goodwell@gmail.com
【AUTHORIZED REPRESENTATIVE】
Lotus NL B.V.
Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands.
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