DE Medical Technology Jiangsu Co.,Ltd

IVD Infections disease diagnostic HIV Rapid test Kit HIV 1/2 Ab home rapid test kit CE Marked

Intended Use of HIV Test Device

Hiv testing equipment is based on the principle of sandwich immunoassay for a qualitative detection of antibody to human immunodeficiency virus HIV in human blood.

Principle

The product is made of gene recombinant human immunodeficiency virus Ⅰ type, Ⅱ type (HIV1 + 2) mixed antigen (p24, gp120, gp41, gp36) and HIV antibodies in nitrocellulose membrane wrapped as a testing lines and qc line, the other with gold particles mark restructuring HIV 1 + 2 antigen (p24, gp120, gp41, gp36), the application of immune chromatography with double antigen detection method principle human serum or plasma of HIV 1 + 2 antibodies.

Products List

Procedure and Result Reading of HIV Rapid Test Device

Before the test pls read the instruction manual.Keep the test strip and the specimen back to room temperature to 20-30 °C. If not ready, do not tear foil bag, kits without the package shall be used within 1 hour (20%-90% humidity)

1. Remove the strip from the foil bag.

2. Use the dropper, drip one drop (25ul) specimen to the stirp.

3. And meanwhile add two drops (80ul-100ul) Sample Diluent into the strip.

4. Wait for 15-20 minutes and read results. Over 20 min, the result is invalid.

Interpretation of results?

Positive: Two red band appears in the test area (T), another in the control area(C).

Negative: Only control line (C) a red band appears in the detection zone (T) without the red band appears.

Invalid: Quality control area (C) does not appear red band, indicating that the operator error or reagent failure.