may appear, which do not interfere with the test results. Presence of a band at the test region(s) even if low in intensity or formation is a positive result.

 

Sample Collection

1. Retroscreen-HIV uses human serum/plasma as

specimen.

2. No special preparation of the patient is necessary

prior to specimen collection by approved

techniques.

3. Preferably use fresh sample. However, specimen

may be stored refrigerated (2–8°C) for short duration.

For long storage, freeze at –20°C or below.

4. If serum is to be used as speciemen, allow blood to

clot completely. Centrifuge to obtain clear serum.

5. Repeated freezing and thawing of the specimen

should be avoided.

6. Do not heat inactivate before use.

7. Do not use turbid, lipemic and hemolyzed serum/

plasma.

8. Do not use hemolyzed, clotted or contaminated

specimens.

9. Specimen containing precipitates or particulate

matter must be centrifuged and the clear supernatant

only used for testing.

10. Refrigerated specimens must be brought to room

temperature prior to testing.

Precautions

1. For in vitro diagnostic use only. Not for medicinal

use.

2. Bring all reagents and specimen to room temperature

before use.

3. Do not use beyond expiration date.

4. Read the instructions carefully before performing

the test.

Serology/Immunology 673

5. Handle all specimens as if potentially infectious.

6. Do not pipette any material by mouth.

7. Do not eat, drink or smoke in the area where testing

is done.

8. Use protective clothing and wear gloves when

handling samples.

9. Use absorbent sheet to cover the working area.

10. Immediately clean up any spills with sodium

hypochlorite.

11. Dispose off all the reagents and material used as if

they contain infectious agent.

12. Do not mix components of one lot with another.

13. If desiccant color at the point of opening the pouch

has turned from blue to pink, another test device

must be run.

Test Procedure

1. Bring the sealed aluminium foil pouch of RetroscreenHIV device to room temperature.

2. Open a foil pouch by tearing along the “notch”.

3. Remove the testing device and the specimen dropper.

Once opened, the device must be used immediately.

4. Label the device with specimen identity.

5. Place the testing device on a flat horizontal surface.

6. Carefully dispense one drop (25 µL) of serum/

plasma into the specimen well “S” using the sample

dropper provided.

7. Add two drops of sample running buffer into the

same well “S”.

8. Observe the development of visible colored band at

test regions (HIV-1 and HIV-2).

9. Positive results may be onserved within 15 minutes.

10. The test should be considered invalid if the control

band (CTNL) does not appear. The test is also invalid

if neither the control nor the test bands appear.

Repeat the test with a new Retroscreen-HIV device.

Limitations

1. Retroscreen-HIV alone cannot be used to diagnose

HIV infection even if the sample is repeatedly or has

high intensity of bands.

2. A negative result with Retroscreen-HIV does not

preclude the possibility of exposure to or infection

with HIV.

3. The membrane is laminated with an adhesive tape to

prevent surface evaporation. Air pockets or patches

may appear, which do not interfere with the test

results. Presence of a band at the test region(s) even

if low in intensity or formation is a positive result.

4. The deliberate slow reaction kinetics of RetroscreenHIV is designed to maximize and enhance reaction

time between sample capture and tracer elements to

improve test sensitivity.

5. Most positive results develop within 15 minutes.

However, certain sera sample may take a longer time

to flow. Therefore, negatives should be confirmed

only at 30 minutes. Do not read results after 30

minutes.