CONTENT (EACH UNIT)
Ø A HIV 1+2 Whole Blood Test
Ø A lancet
Ø A dropper
Ø A alcohol pad
Ø A desiccant
NOTE: A instruction note will be attached together
MANUFACTURER
Product is manufactured by one of the leading one of the leading rapid diagnostics test device manufacturer located at Malaysia which established since 1996 and they have their own in house R&D department for continuous research and develop new product and improvement. The factory is an ISO 13485:2012 / AC2012 certified company and compliance to GMP QSR & CE regulations
NAME AND INTENDED USE
The Fourth Generation AHP™ Rapid HIV 1 & 2 Test is a single-use immunochromatographic assay for the detection of antibodies to Human Immunodeficiency Virus Types 1 (HIV-1) and Type 2 (HIV-2) in fingerstick whole blood, venous whole blood, and serum or plasma specimens. The AHP™ Rapid HIV 1 & 2 test is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and HIV-2.
STORAGE
The AHP™ Rapid HIV 1 & 2 Test should be stored in its unopened pouch at 8 to 30°C (46 to 86°F). Do not freeze. Do not open the pouch until you are ready to perform a test. When stored as indicated, test devices are stable until the expiration date marked on the pouch. Unopened AHP™ Rapid HIV 1 & 2 Tests should be stored in a dry area at 15 - 30°C. Keep the test cartridges in sealed packages until use. If tests are stored at refrigerated temperatures, allow all test components and specimens to equilibrate to room temperature (15-30°C) for 30-60 minutes prior to opening the packages.
SPECIMEN COLLECTION
Prior to specimen collection, provide test subjects with Subject Information Notice and pre-test counseling according to CDC Guidelines for Rapid HIV Testing.
The AHP™ Rapid HIV 1 & 2 Test is performed on fingerstick whole blood, venous whole blood, serum or plasma specimens.
Fingerstick Whole Blood:
1. Clean the area to be lanced with an alcohol swab.
2. Squeeze the end of the fingertip and pierce it with sterile lancet.
3. Wipe away the first drop of blood with sterile gauze or cotton.
4. Use micropipette to obtain about 70 ul fresh blood.
5. Add about 30 to 50 ul of blood into sample well, wait one minute until all blood is completely absorbed.
6. Observe the result in 10 to 30 minutes.
INTERPRETATION OF TEST RESULTS
When the AHP™ Rapid HIV 1/2 test is properly performed, the appropriate pink/purple lines will become visible. These are:
1. The CONTROL LINE - which appears closer to the top ofthe test strip, indicates that specimen was adequately applied, and there was proper hydration and migration of reagents. The control line will become visible within 5 minutes after starting the test regardless of the HIV antibody status of the specimen.
2. The TEST LINE - which appears closer to the bottom ofthe test strip (below the control line) indicates the presence of HIV-specific antibodies. The test line will become visible within 5 minutes after starting a valid test when HIV specific antibodies are present at detectable levels in the specimen.
NONREACTIVE (diagram 1):
One pink/purple line in the CONTROL area, with no line in the TEST area indicates a NONREACTIVE Test Result. A NONREACTIVE Test Result means that HIV-1 and HIV-2 antibodies were not detected in the specimen. The Test Result is interpreted as NEGATIVE for HIV-1 and HIV-2 antibodies. However, this does not exclude possible infection with HIV. Follow CDC guidelines to inform the test subject of the Test Result and its interpretation.7
REACTIVE (diagram 2):
Two pink/purple lines, one in the TEST area and one in the CONTROL area indicate a REACTIVE Test Result. The line in the TEST area may look different from the line in the CONTROL area. Intensities of the Test and Control Lines may vary. Test Result with visible lines in both TEST and CONTROL areas, regardless of intensity, is considered REACTIVE. A REACTIVE Test Result means that HIV-1 and/or HIV-2 antibodies have been detected in the specimen. The Test Result is interpreted as Preliminary POSITIVE for HIV-1 and/or HIV-2 antibodies. Follow CDC guidelines to inform the test subject of the Test Result and its interpretation. 7,
INVALID (diagram 3):
A pink/purple line should always appear in the CONTROL area, whether or not a line appears in the TEST area. If there is no distinct pink/purple line visible in the CONTROL area (see diagrams 3), then the test is INVALID. An INVALID test cannot be interpreted. It is recommended that the INVALID test be repeated with a new device.
SENSITIVITY
The sensitivity and specificity study was evaluated using a total of 100 test kits. The tests were carried out by the Infectious Disease Research Centre (IDRC) at the Institute of Medical Research, Malaysia. Stored frozen sera were provided by the National Aids Reference Laboratory in the Institute of Medical Research. A total of well characterized sera consisting of 50 sera from HIV 1 negative individuals and 50 from true HIV 1 positive individuals were tested using Allen Healthcare’s Rapid HIV 1 & 2 Test.
The AHP™ Rapid HIV 1 & 2 test has correctly identified all the HIV 1 Ab positive sera and HIV 1 Ab negative sera. This gives the test an overall sensitivity of 100% (50/50) and specificity of 100% (50/50). The result obtained from this evaluation also indicate that the kit produce an estimated value of 100% for both PPV and NPV.
LIMITATIONS OF THE PROCEDURE
1. The AHP™ Rapid HIV 1/2 test must be used in accordance with the instructions in this Product Insert to obtain accurate results.
2. The AHP™ Rapid HIV 1/2 test must be used with capillary (fingerstick) or venous whole blood, serum or plasma only. Use of other types of specimens or testing of venipuncture whole blood specimens collected using a tube containing an anticoagulant other than citrate, heparin or EDTA may not yield accurate results. For serum samples, collect blood without anticoagulant.
3. Reading Nonreactive Test Results earlier than 5 minutes or any Test Result later than 30 minutes may yield erroneous results.
4. Do not open the sealed foil pouch until just prior to use.
5. Do not use Kit contents beyond labeled expiration date.
6. For the collection of the fingerstick whole blood specimen, ensure that finger is completely dry before performing fingerstick.
7. Read results in a well-lit area.
8. A Reactive Test Result using the AHP™ Rapid HIV 1/2 test suggests the presence of antibodies to HIV-1 and/or HIV-2 in the specimen. The AHP™ Rapid HIV 1/2 assay is intended as an aid in the diagnosis of infection with HIV-1/2. AIDS and AIDS-related conditions are clinical syndromes and their diagnosis can only be established clinically.
9. For a Reactive Test Result, the intensity of the test line does not necessarily correlate with the titer of antibody in the specimen.
10. A person who has antibodies to HIV-1 or HIV-2 is presumed to be infected with the virus, except that a person who has participated in an HIV vaccine study may develop antibodies to the vaccine and may or may not be infected with HIV.
11. A Nonreactive Test Result does not preclude the possibility of exposure to HIV or infection with HIV. An antibody response to recent exposure may take several months to reach detectable levels.
12. This assay has not been evaluated for newborn screening, cord blood specimens, or individuals less than 13 years of age.