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
  • EUA Cleared
  • Results delivered within minutes

TEST PROCEDURE

step1 - Add 1 drop of whole blood
step2 - Place 2 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 M+C = Patient has Covid19 and is in the early phase
  • IgG and IgM Positive (b): Colored line near G+M+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:

  • Developer: Healgen
  • Test: COVID-19 IgG/IgM Rapid Test Cassette
  • Technology: Lateral Flow
  • Target: Spike
ANTIBODY PERFORMANCE MEASURE ESTIMATE OF PERFORMANCE 95% CONFIDENCE INTERVAL
IgM Sensitivity 100% (30/30) (88.7%; 100%)
IgM Specificity 100% (80/80) (95.4%; 100%)
IgG Sensitivity 96.7% (29/30) (83.3%; 99.4%)
IgG Specificity 97.5% (78/80) (91.3%; 99.3%)
Combined Specificity 100% (30/30) (88.7%; 100%)
Combined Specificity 97.5% (78/80) (91.3%; 99.3%)
Combined PPV at prevalence = 5% 67.8% (35.0%; 88.4%)
Combined NPV at prevalence = 5% 100% (99.4%; 100%)

Package Includes

25 test per kit

Each kit includes 25 cassettes, 25 pipettes, 1 buffer solution

Product code - COVTEST2