Cellex SARS-CoV-2 IgG/IgM Cassette Rapid Test

The Cellex SARS-CoV-2 IgG/IgM Cassette Rapid Test is a lateral flow immunoassay for qualitative detection of antibodies to 2019 novel coronavirus (SARS-CoV-2) in serum, plasma, or whole blood specimens. It is intended to be used as an aid in the diagnosis of SARS-CoV-2 viral infections. Any reactive specimen with the Cellex SARS-CoV-2 IgG/IgM Cassette Rapid Test must be confirmed with alternative testing method(s). For prescription use only. For in vitro diagnostic use only. For emergency use with authorization use only.

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 infected humans yet.

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 reported with SARS-CoV-2 viral infections had mild to severe respiratory illness with symptoms of: fever, cough, shortness of breath. There is an urgent need for rapid tests to manage the ongoing pandemic. The SARS-CoV-2 IgG/IgM Rapid Test is intended for rapid and qualitative detection of antibodies indicative of SARS-CoV-2 infection and used as an aid for diagnosis of SARS-CoV-2 infection.

The Cellex SARS-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 an IgG line (G Line) coated with anti-human IgG, an IgM line (M Line) coated with anti-human IgM, and the C line (C Line) 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. The anti-SARS-CoV-2 virus IgG, if present in the specimen, will bind to the SARS-CoV-2 conjugates. The immunocomplex is then captured by the anti-human IgG line, forming a burgundy colored G line, indicating a SARS-CoV-2 virus IgG positive test result suggesting a secondary infection or previous 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 line, forming a burgundy colored M line, indicating a SARS-CoV-2 virus IgM positive test result suggesting a fresh primary infection.

If both G line and M line 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 line) 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 again.

There are three kit sizes. Their kit component configurations are provided below:

1) Transfer Pipette Set

2) Timer

3) Specimen Collection Containers

1. Store the sample diluent at 4-30℃. The buffer is stable up to 30 months.

2. Store Cellex SARS-CoV-2 IgG/IgM Cassette Rapid Test at 4-30℃; shelf life is up to 30 months.

3. If stored at 2℃-8℃, ensure that the test device is brought to 15℃-30℃ before opening.

4. Do not freeze the kit or store the kit over 30℃.

Step 1: For fresh sample, begin with Step 2. For frozen samples, bring the specimens and test components to room temperature, mix the specimen well prior to assay once thawed.

Step 2: When ready to test, open the pouch at the notch and remove device. Place the test device on a clean, flat surface.

Step 3: Label the device with specimen ID number.

Step 4: Using a transfer pipette, transfer serum, plasma or whole blood not to exceed the specimen line. The volume of the specimen is around 10μL. For better precision, transfer specimen by a pipette capable of delivering 10μL of volume. Holding the transfer pipette vertically, dispense the entire specimen into the center of the sample well (S well) making sure that there are no air bubbles. Then add 2 drops (about 70-100 μL) of Sample Diluent immediately into the sample well (S well).

Step 5: Set up a timer

Step 6: Read the result in 15-20 minutes. Don’t read result after 20 minutes. To avoid confusion, discard the test device after interpreting the result.

While we believe this kit is to be an effective indicator of infection we cannot guarantee 100% accuracy so the patient should still be advised to follow government guidelines for those exhibiting symptoms and those who aren’t regarding hygiene, self-isolation and other measures even if the test is negative.

• Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
• Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
• Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
• This kit is for Professional-Use-Only.