COVID-19 rapid test kit
available for African countries (TGA approved)
The COVID-19 IgG/IgM Rapid Test is a lateral flow immunoassay for the detection of anti-SARS-CoV-2 IgG and IgM antibodies in human serum, plasma or whole blood. It is intended to be used by healthcare professionals as an aid in the diagnosis of infection with SARS-CoV-2 coronavirus.
Any interpretation or use of this preliminary test result must also rely on other clinical findings as well as on the professional judgment of healthcare providers. Alternative test method(s) should be considered to confirm the test result obtained by this device.
The COVID-19 IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay. The test strip in the cassette consists of: 1) a colored conjugate pad containing SARS-CoV-2 recombinant antigens conjugated with colloidal gold (SARS-CoV-2 conjugates) and a control antibody conjugated with colloidal gold, 2) a nitrocellulose membrane strip containing two test lines (G and M lines) and a control line (C line). The G line is pre-coated with antibodies for the detection of anti-SARS-CoV-2 IgG, the M line is pre-coated with antibodies for the detection of anti-SARS-CoV-2 IgM, and the C line is pre-coated with a control line antibody.
When an adequate volume of specimen is dispensed into the sample well of the test cassette, the specimen migrates by capillary action along the cassette strip. Anti-SARS-CoV-2 IgG, if present in the specimen, will bind to the SARS-CoV-2 conjugates. The immunocomplex is then captured by the pre-coated anti-human IgG, forming a colored G line, indicating an anti- SARSCoV- 2 IgG positive test result, suggesting a recent infection or a past infection. Anti-SARS-CoV- 2 IgM, if present in the specimen, will bind to the SARS-CoV-2 conjugates. The immunocomplex is then captured by the pre-coated anti-human IgM, forming a colored M line, indicating an anti-
SARS-CoV-2 IgM positive test result and suggesting an acute SARS- CoV-2 infection. An IgM and IgG double positive result suggests a late acute infection. Absence of any of the test lines (G or M) suggests a negative result. Each test contains an internal control (C line) which should exhibit a colored line of the control antibodies regardless of color development on any of the test lines. If the C line does not develop, the test result is invalid, and the specimen must be retested with another device.
- CE Conformity
- ISO 13485 QMS
- TGA Approved
- SAHPRA conformity
- SA Free sales certificate
15 -20 days depending on country of delivery and time of payment
Reagents and Materials provided
- Individually sealed foil pouches containing:
a. One cassette device
b. One desiccant
- Plastic droppers
- Detection buffer (REF SB-R0180, 3 mL/bottle)
- Instructions for Use
- Shipments are fully traceable
- We are customer focused and understand urgent orders
- We are adaptable in these ever changing times
- We are constantly in contact with operational cargo ships during the COVID-19 crisis