HEALGEN HIV 1/2 One Step Rapid Test Cassette

Product Name

HEALGEN HIV 1/2 Human

Immunodefficiency Virus Rapid

Test

Purpose

for the qualitative detection of antibodies to HIV-1 and/or HIV- 2 in whole blood, serum or plasma.

Remove the test device from the foil pouch and use it as soon as

possible. Best results will be obtained if the assay is performed within

one hour.

2. Place the test device on a clean and level surface. For Serum or Plasma

Specimens: Hold the dropper vertically and transfer 1 drop of serum or

plasma (approximately 30 μL) to the specimen well (S) of the test

device, then add 1 drop of buffer (approximately 40 μL) and start the

timer. See illustration below. For Venipuncture Whole Blood

Specimens: Hold the dropper vertically and transfer 2 drops of

venipuncture whole blood (approximately 50μL) to the specimen well

(S) of the test device, then add 1 drop of buffer (approximately 40 μL)

and start the timer. See illustration below. For Fingerstick Whole Blood

Specimens: Allow 2 hanging drops of fingerstick whole blood

(approximately 50 μL) to fall into the center of the specimen well (S) on

the test device, then add 1 drop of buffer (approximately 40 μL) and

start the timer. See illustration below.

3. Wait for the red line(s) to appear. The result should be read in 15

minutes. Do not interpret the result after 15 minutes.

Sensitivity &

Specificity

Sensitivity 99.5 %

Specificity 99.8%

Accuracy results are based on the

evaluation of the National HIV

Reference Laboratory, Clinical

Pathology FKUI-RSCM :

Sensitivity 98.64 %

Specificity 99.43%

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