The COVID-19 IgG/IgM Rapid Antibody Test has emerged as a critical part of the arsenal for delivering a swift diagnosis and discovery of Antibodies - with results in 15 minutes or less. Deploy these tests in a variety of locations such as physicians' offices, urgent care clinics and other point-of-care locations.

Because of its portability and speed, rapid IVD testing has been crucial in battling COVID-19 across the globe.

Features and Benefits

  • Qualitative detection of IgG and IgM antibodies that bind to COVID-19 causing virus
  • Simple and easy to use
  • Healthcare providers can administer tests at the point-of care or laboratories
  • Pre-EUA Cleared
  • Results delivered within minutes

TEST PROCEDURE

step1 - Add 1 drop of whole blood
step2 - Place 2-3 drops of buffer
step3 - Read result in 5-10 minutes, no later than 15 minutes

Interpretation of Results

POSITIVE:

  • IgM Positive (a): Colored line near lgM+C = Patient
    has Covid19 and is in the early phase
  • IgG and IgM Positive (b): Colored line near
    lgG+lgM+C = Patient has Covid19 and is in
    the advanced phase
  • IgG Positive (c): Colored line near IgG+C = Patient
    had Covid19 and now has IgG antibodies
IgM Positive IgG and IgM Positive IgG Positive

NEGATIVE:

Colored line near C appears and no other colored line appears

negative

INVALID:

1. No line appears
or
2. Unreadable

invalid

Performance Characteristics:

  • The COVID-19 lgG/lgM Rapid Test has been evaluated with the 800 samples (of 708 cases) obtained from patients exhibiting pneumonia or respiratory synptoms
  • The results were compared to clinical diagnosis of COVID-19
  • Among the 800 samples, a total of 40 samples from 19 cases with incompleted information or repeated tests are excluded
  • As a result, 760 samples from 689 cases were included in the statistics
COVID-19 Antibody (lgM/lgG) Combined Test Kit Clinical Case
CONFIRMED EXCLUDED TOTAL
Positive 280 39 319
Negative 6 435 441
Total 266 474 760
Results
Sensitivity..................97.90%
Specificity..................91.77%
Overall........................94.08%

Package Includes

25 test per kit

Each kit includes 25 cassettes, 25 pipettes, 2 buffer solutions

Product code - COVTEST