LifeSADX CoV-2 IgT
Intended for qualitative detection of total antibodies (IgA, IgG, IgM) to SARS-CoV-2 in human capillary blood, serum, and anticoagulated venous blood (heparin, EDTA). The LifeSADX CoV-2 IgT is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.
This SARS-CoV-2 lateral flow assay detects total antibodies (IgA/IgG/IgM) against SARS-CoV-2 in human blood and serum. SARS-CoV-2 antibodies in the specimen bind to SARS-CoV-2 antigen-coated gold nanoparticles (AuNP) forming AuNP-complexes. As these AuNP-complexes flow across the test membrane, they are captured at the test line, forming a visible red line. When no SARS-CoV-2 antibodies are present in the specimen, no test line will form. Any unbound AuNP-complexes migrate to the control line (C), where they are captured to form a visible red line, indicating the reaction is complete.
Total samples: n=425
Specificity (n=276): >99%
Specificity on HIV positives (n=40): 100%
Sensitivity: (0-7 days, n=33): 93.9% [85.8, 100]
(8-14 days, n=74): 100% [98, 100]
(≥15 days, n=42): 100% [98, 100]
Overall PPA: >95%
Data consistency: Kappa = 0.979
Matrix agreement: 100% between fingerstick, venous blood and serum.
Cross-reactivity: The study population (n=276) had a high prevalence of vaccination against, and/or infection with influenza A, influenza B, HCV, HBV, H. influenzae, 229E,
NL63, OC43, HKU1, ANA, ARSV, and a notably high prevalence of HIV. Assuming an infection rate of other corona viruses of 15% in the population, a minimum of 40 false positive were expected, but only 2 false positives were noted. The LifeSADX CoV-2 IgT assay appears to be highly specific to SARS-CoV-2.
Procedure for using VENOUS BLOOD:
Bring the blood sample to room temperature before testing (18°C to 28°C / 64.4°F to 82.4°F).
Remove the cassette from the aluminum foil pouch and place it on a flat and dry surface.
Use a micropipette and add 20ul anticoagulated blood (di-potassium EDTA or sodium heparin) to the sample (S) well. Add two (2) drops of buffer to the (S) well, and start timer. Record results at 10 minutes.
Note: Treat all used tests, test components, and gloves as potentially highly infectious, and discard as biomedical waste.
This test has not been reviewed by the FDA.
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.
Not for the screening of donated blood.
Not for self-testing or home use.
All results must be interpreted together with a clinical examination and confirmed with standard laboratory methods.
The test cannot be used to monitor medication or disease progression.
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