The 15-mins ideal diagnostic test for COVID-19---with US FDA and TGA certificate

-Sample: serum/plasma/whole blood

-Accurate and reliable results: Positive coincidence rate is 93.8%, Negative coincidence rate is 96.0%

-Easy to operate

-Affordable for different health systems

INTENDED USE
The Cellex qSARS-CoV-2 IgG/IgM Cassette Rapid Test is a lateral flow immunoassay for the qualitative detection of 2019 novel coronavirus (SARS-CoV-2) in serum、plasma or whole blood specimens. It is intended to be used as a screening test and aid in the diagnosis of SARS-CoV-2 viral infections. Any reactive specimen with the Cellex qSARS-CoV-2 IgG/IgM Cassette Rapid Test must be confirmed with alternative testing method(s).
For in vitro diagnostic use only. For professional use only.
SUMMARY AND EXPLANATION OF THE TEST
Coronaviruses (CoV) are a large family of viruses that cause illness ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV). SARS-CoV-2 is a new strain that has not been previously identified in humans. Coronaviruses are zoonotic, meaning they are transmitted between animals and people. Detailed investigations found that SARS-CoV was transmitted from civet cats to humans and MERS-CoV from dromedary camels to humans. Several known coronaviruses are circulating in animals that have not yet infected humans.
2019 Novel Coronavirus (SARS-CoV-2) is a virus (more specifically, a coronavirus) identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. Patients with SARS-CoV-2 have reportedly had mild to severe respiratory illness with symptoms of: fever, cough, shortness of breath. The rapid test has become an urgent need for screening patients.
The qSARS-CoV-2 IgG/IgM Rapid Test is intended to meet all requirements for yielding rapid, easily read, qualitative results for the main purpose of SARS-CoV-2 infection diagnosis.
TEST PRINCIPLE
The Cellex qSARS-CoV-2 IgG/IgM Cassette Rapid Test is a lateral flow chromatographic immunoassay which can detect antibodies against the SARS-CoV-2 virus. The test cassette consists of: 1) a burgundy colored conjugate pad containing SARS-CoV-2 recombinant antigens conjugated with colloidal gold (SARS-CoV-2 conjugates) and rabbit IgG-gold conjugates,2) a nitrocellulose membrane strip containing anti human IgG, M band is coated with anti human IgM, and the C band is pre-coated with goat anti rabbit IgG.
When an adequate volume of test specimen is dispensed into the sample well of the test cassette, the specimen migrates by capillary action along the cassette. IgG anti-SARS-CoV-2 virus, if present in the specimen, will bind to the SARS-CoV-2 conjugates. The immunocomplex is then captured by the anti human IgG band, forming a burgundy colored G band, indicating a SARS-CoV-2 virus IgG positive test result suggesting a secondary CoV infection or previous CoV infection.
IgM anti-SARS-CoV-2 virus, if present in the specimen, will bind to the SARS-CoV-2 conjugates. The immunocomplex is then captured by the anti human IgM band, forming a burgundy colored M band, indicating a SARS-CoV-2 virus IgM positive test result suggesting a fresh primary infection.
If both G band and M band are visible, the test result suggests late primary or early secondary SARS-CoV-2 infection. Absence of both test bands (G and M) suggests a negative result.
The test contains an internal control (C band) which should exhibit a burgundy colored band of goat anti rabbit IgG/rabbit IgG-gold conjugate immunocomplex regardless of the color development on any of the test bands(G and M). Otherwise, the test result is invalid and the specimen must be retested with another device.
REAGENTS AND MATERIALS
Reagents and Materials Provided
1. 25 test cassettes
2. 1 bottle of sample buffer
3. 25 Capillary tubes
4. Leaflet with instruction for use
Composition and Concentration
Conjugate pad Monoclonal Anti-SARS-CoV-2 antigen conjugated on the membrane
G line Anti human IgG
M line Anti human IgM
C line Goat anti rabbit IgG
Sample Buffer 0.01M PBS; PH 7.4
Material Required But Not Provided
1. Transfer Pipette Set
2. Timer
3. Specimen Collection Containers

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