1. Ready to use individually pouched, flow through test
devices striped with HIV-1 specific purified synthetic
peptides at test region ‘1’ and HIV-2 specific purified
synthetic peptides at test region ‘2’ and a blue dyed
protein A based control band at region ‘C’ along with
a specimen dropper and dessicant.
2. Dropper bottle with ready to use wash buffer solution.
3. Dropper bottle with ready to use protein A conjugated
the duration of the shelf-life as indicated on the kit/kit
1. In vitro diagnostic test. Not for medicinal use.
2. Read package insert carefully before performing the
3. Do not use beyond expiry date.
4. Flow through device, wash buffer and protein A
conjugate of the same lot are optimized as a system.
It is important that the kit components of the same
lot are used for achieving accurate and reproducible
results. Do not intermix reagents from different lots.
5. The sequence of addition of reagents should be
followed meticulously for achieving accurate results.
6. Handle all specimens as potentially infectious.
7. Follow standard biosafety guidelines for personal
protection, handling and disposal of potentially
8. After use, the kit components must be returned to the
recommended storage temperature immediately.
Specimen Collection and Preparations
1. No prior preparation of the patient is required before
sample collection by approved techniques.
2. Fresh serum/plasma is preferable. Serum/plasma may
be stored at 2 to 8° C upto 24 hours in case of delay in
testing. For long-term storage, freeze the specimen at
3. Repeated freezing and thawing of the specimen should
4. Do not use hemolyzed, clotted, contaminated,
5. Specimen containing precipitates or particulate matter
must be centrifuged and the clear supernatant only
6. Do not heat -inactivate the specimen.
7. Frozen samples for retrospective studies must be
centrifuged at 3000 rpm for 15 minutes and the clear
supernatant must be used for tests.
1. Bring all reagents and specimen to room temperature
(25–30°C) before use. Tighten the Wash Buffer solution
and Protein A Gold Conjugate dropper bottle caps in
a clockwise direction to pierce the respective dropper
bottle nozzles. The addition of specimen/ reagents
must be done at the center of the reaction port, holding
the sample dropper/dropper bottles in a vertical
position. Ensure the drops are free falling. Use a new
sample dropper for each specimen to avoid cross
2. Tear open the foil pouches and retrieve the required
number of Retroquick-HIV membrane test devices
3. Add two drops of wash buffer into the reaction port of
the device and allow to soak through completely.
4. Using the sample dropper provided, add one drop of
the serum/plasma specimen into the reaction port.
Allow to soak through completely.
5. Add three drops of wash buffer to the reaction port
and allow to soak through completely.
6. Add two drops of protein A gold conjugate to the
reaction port and allow to soak through completely.
7. Add two drops of wash buffer and allow the wash
buffer to soak through completely.
8. Read and record the results immediately.
Appearance of only one control band corresponding to control
In addition to the control band ‘C’, appearance of reactive band
at test region ‘1’: Specimen positive for Antibodies to HIV 1.
In addition to the control band ‘C’, appearance of reactive
band at test region ‘2’: Specimen positive for Antibodies to HIV 2.
In addition to the control band ‘C’, appearance of reactive
bands at test region ‘1’ and test region ‘2’ Specimen positive for
Antibodies to HIV 1 and HIV 2.
The test should be considered invalid if neither the test
No comments:
Post a Comment
اكتب تعليق حول الموضوع