Test-it CoV-2 IgM/IgG Test Kit

A lateral Flow Immunoassay

intended for qualitative detection of specific IgM and IgG antibodies to SARS-CoV-2 in human capillary blood, serum, and anticoagulated venous blood (heparin, EDTA). The Test-it CoV-2 IgM/IgG Test Kit is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.

Principle

This SARS-CoV-2 lateral flow assay consists of disease specific IgM and IgG test components. 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 anti-human IgM and/or anti-human IgG test lines, forming visible red lines.
When no SARS-CoV-2 IgM or IgG antibodies are present in the specimen, no IgM or IgG test lines are visible. 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.

Stability

The test met all requirements regarding linearity, repeatability, negative reference agreement, specificity and sensitivity of the test kit, 10 days after annealing at 37 degrees Celsius.

Instructions for Use:

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 5μl 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.

Procedure for using SERUM:

Bring serum 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 5ul serum 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.

Kit Components:

  • 25 test casettes
  • 25 pipettes
  • 25 safety lancets
  • 3 bottles running buffer
  • 1 IFU (instructions for use)

Test Limitations:

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 prsent infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43 or 229E.
Not for the screening of donated blood.
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.


For more Information and pricing please contact: info@lifesadx.com