EcoTest® COVID-19 Rapid Diagnostic Antibody Test Kit, FDA EUA Authorized, CE Approved, 20/Box
EcoTest® COVID-19 Rapid Diagnostic Antibody Test Kit, FDA EUA Authorized, CE Approved, 20/Box
The COVID-19 IgG/IgM Rapid Test Device is an in vitro immunoassay for detecting anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG in human whole blood, serum, or plasma in a direct and qualitative manner.
EcoTest® COVID-19 Rapid Diagnostic Antibody Test Kit, FDA EUA Authorized, CE Approved, 20/Box
The COVID-19 IgG/IgM Rapid Test Device is an in vitro immunoassay for detecting anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG in human whole blood, serum, or plasma in a direct and qualitative manner.
Designed to detect people who have developed an adaptive immune response to SARS-CoV-2, indicating that they have been infected with the virus recently or previously.
In minutes, you’ll have results.
Through a fingerstick, the virus is detected in whole blood.
For lab use, venous whole blood, plasma, or serum can be employed.
Performance at a 95% confidence level.
At about 5% of the cost of a PCR test, this method is cost-effective.
Through visual interpretation of color development, the COVID-19 IgG/IgM Rapid Test Device detects anti-SARS-CoV-2 IgG/IgM antibodies. Specific antibodies in human whole blood, serum, or plasma are detected using anti-human IgG and anti-human IgM.
Specific IgM and/or IgG antibodies will bind to the SARS-CoV-2 antigens conjugated to colored particles on the conjugation pad when the specimen is put to the sample well.
Anti-human IgM and/or anti-human IgG antibodies immobilized on the test region will capture the complex as it migrates along the strip by capillary action and interacts with reagents on the membrane (s).
The internal control zone captures any extra colored particles. A positive result for the specific IgG and/or IgM antibodies is shown by the appearance of a red band(s) on the test region(s), whereas its absence indicates a negative result. A procedural control, a crimson band in the control region (C), indicates that membrane wicking is working.
Antibodies can be detected 5 to 7 days after symptoms first appear.
TEST PROCEDURE
RESULTS INTERPRETATION
NEGATIVE
The coloured line in the control line region (C) changes from blue to red. No line appears in the test line regions M or G.
The result is Negative.IgM POSITIVE
The coloured line in the control line region (C) changes from blue to red, and a coloured line appears in test line region M.
The result is anti-COVID-19 IgM Positive.IgG POSITIVE
The coloured line in the control line region (C) changes from blue to red, and a coloured line appears in test line region G.
The result is anti-COVID-19 IgG Positive.
IgG and IgM POSITIVE
The coloured line in the control line region (C) changes from blue to red, and two coloured lines appear in test line regions M and G.
The result is anti-COVID-19 IgM and IgG Positive.INVALID
Control line is still completely or partially blue, and fails to completely change from blue to red. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new cassette. If the problem persists, discontinue using the kit immediately and contact your distributor.
CLINICAL DATA
This product is FDA EUA Authorized, CE Approved, Health Canada Approved
Product Non-Refundable, Non-Returnable
Contents: (20) Sealed Test Devices, (20) Assay Buffer, (20) Extraction Vials and Caps, (20) Specimen Collection Swabs, (1) Positive and (1) Negative Control Swabs , (1) Instructions for Use
