Healgen Rapid Antibodies Test for COVID-19

• Clinical Evaluation
  • Positive Percent Agreement (PPA): IgG 96.7%; IgM 86.7%; Overall 96.7%
  • Negative  Percent Agreement (NPA): IgG 98.0%; IgM 99.0%; Overall 97.0%
• Clinical Agreement with Characterized Samples
  • Sensitivity: IgG 96.7%; IgM 100%; Combined 100%​
  • Specificity: IgG 97.5%; IgM 100%; Combined 97.5%​
• Specimen: Whole Blood, Serum, Plasma
• Time to Results: 10 minutes
• Shelf Life: 24 months from the date of manufacture
• Quantity: 25 Tests/Kit

Covid-19 Fact Sheets

Instructions for Use:

1. Remove the test cassette from the sealed foil pouch and use it as soon as possible.

2. Lay device on flat surface and add specimen (see specific instructions for each specimen type below):

a. For Serum or Plasma Specimen: With the plastic dropper provided, draw serum/plasma specimen to exceed the specimen line, as shown in the diagram below. Hold the dropper vertically and transfer drawn serum/plasma specimen into the sample well (S). Immediately add 2 drops (about 80 μL) of sample buffer to the buffer well (B) ensuring that buffer vial tip does not touch the sample. Avoid air bubbles.

b. For Whole Blood Specimen: Hold the plastic dropper vertically and transfer 1 drop of whole blood (about 10 μL) to the sample well (S) of the test device. Immediately add 2 drops (about 80 μL) of sample buffer to the buffer well (B) ensuring that buffer vial tip does not touch the sample. Avoid air bubbles.

3. Wait for the control line (C) to change from blue to a red color. If, after 2 minutes, the sample has not moved across the test window or if blood is still present in the sample well (S), add 1 additional drop of sample buffer to the buffer well (B).

4. The results should be read in 10 minutes. Do not interpret the result after 15 minutes.

Healgen COVID 19 Antibody Test Instruction Video