FAMKA STD-HIV Antibody Rapid Test Instruction Manual
- June 5, 2024
- FAMKA
Table of Contents
FAMKA STD-HIV Antibody Rapid Test
INTENDED USE
The HIV 1/2/0 Antibody Rapid Test is an indirect lateral flow chromatographic
immunoassay for the simultaneous detection and differentiation of lgG anti-
HIV-1,anti-HIV-2, and anti-HIV-O antibodies in human serum, plasma, or whole
blood. It is intended to be used as a screening test and as an aid in the
diagnosis of infection with HIV. Any reactive specimen with the HIV -1/2/0
Antibody Rapid Test must be confirmed with alternative testing methods
PRINCIPLE
The HIV 1/2/0 Antibody Rapid Test is an indirect lateral flow chromatographic
immunoassay. The test cassette consists of 1) a burgundy-colored conjugate pad
containing mouse monoclonal anti-human lgG antibody conjugated with colloid
gold (Human LG Conjugates), 2) a nitrocellulose membrane strip containing two
test bands (T1 and T2 bands) and a control band (C band). The T1 band is pre-
coated with recombinant HIV-1 antigen GP 120 / gp41 and HIV-2 antigen gp36 for
the detection of antibodies to HIV-1 and HIV-2, and the T2 band is pre-coated
with HIV-O antigen gp120/gp41 for the detection of antibodies to HIV-O and the
C band are pre-coated with goat anti-mouse lgG antibody. When an adequate
volume of the test specimen is dispensed into the ·sample well of the test
cassette, the specimen migrates by capillary action across the cassette. lgG
anti-HIV-1 antibodies or lgG anti-HIV-2 antibodies if present in the sample
migrate through the conjugate pad where they bind to the Human lgG
conjugates. The immunocomplex is then captured on the membrane by the pre-
coated HIV-1 or HIV-2 antigen, forming a burgundy colored band on the T1
region, indicating a positive test result. The absence of this band in the
test region suggests an HIV -1 and/or HIV-2 antibody negative result. lgG anti
-HIV-O antibodies if present in the sample migrate through the conjugate pad
where they bind to the Human LG Conjugates. The immunocomplex is then captured
on the membrane by the pre-coated HIV-O antigen, forming a burgundy-colored
band on the T2 region, indicating a positive test result.
The absence of this band in the test region suggests an HIV -0 antibody
negative result. The test contains an internal control (C band) which should
exhibit a burgundy colored band of the immunocomplex of goat anti-mouse lgG/
mouse anti-human lgG conjugates regardless of the presence of any colored T
bands. Otherwise, the test result is invalid and the specimen must be retested
with another device.
COMPONENTS
MATERIALS PROVIDED
- HIV 1/2/0 Antibody Rapid Test (Colloidal Gold)
- Pipette
- Buffer
- Lancet
- Alcohol Wipe
- Package Insert
MAT ERIA LS WAS NOT PROVIDED BUT REQUIRED Timer
PRECAUTIONS
- For professional in vitro diagnostic use only.
- Do not use it after the expiration date indicated on the package.
- Do not use the test if the foil pouch is damaged.
- Do not reuse tests.
- Avoid cross-contamination of specimens by using a new specimen container for each specimen obtained.
- Read the entire procedure carefully prior to testing.
- Do not interchange or mix reagents from different lots.
- Humidity and temperature can adversely affect results.
- All patient samples should be treated as if capable of transmitting diseases.
- Used Testing materials should be discarded according to local regulations.
STORAGE AND STABILITY
- The kit should be stored at 2-30 °C until the expiry date is printed on the sealed pouch.
- The test must remain in the sealed pouch until use.
- Do not freeze.
Cares should be taken to protect components in this kit from contamination. Do
not use it if there is evidence of
microbial contamination or precipitation. Biological contamination of
dispensing equipment, containers, or reagents
can lead to false results.
SPECIMENS COLLECTION
Consider any materials of human origin as infectious and handle them using standard biosafety procedures.
Plasma
- Collect blood specimen into a lavender, blue, or green top collection tube (containing EDTA, citrate, or heparin, respectively in Vacutainer by vein
- puncture.
- Separate the plasma by centrifugation.
- Carefully withdraw the plasma into the new pre-labeled tube.
Serum
- Collect blood specimen into a red-top collection tube containing no anticoagulants in Vacutainer by venipuncture.
- Allow the blood to clot.
- Separate the serum by centrifugation.
- Carefully withdraw serum into a new pre-labeled tube. Test specimens as soon as possible after collecting. Store specimens at 2C-8C if not tested
- immediately. Store specimens at 2C – 8C for up to 5 days. The specimens should be frozen at -20C for longer storage.
- Avoid multiple freeze-thaw cycles. Prior to testing, bring frozen specimens to room temperature slowly and mix gently. Specimens containing visible particulate matter should be clarified by centrifugation before testing. Do not use samples demonstrating gross lipemia, gross hemolysis, or turbidity in order to avoid interference with result interpretation.
Whole blood
- Drops of whole blood can be obtained by either a fingertip puncture or a vein puncture. Do not use any hemolyzed blood for testing.
- Whole blood specimens should be stored in refrigeration if not tested immediately. The specimens must be tested within 24hours of collection.
ASSAY PROCEDURE
- Bring the specimens and test components to room temperature if refrigerated or frozen. Mix the specimen well prior to assay once thawed.
- When ready to test, open the pouch at the notch and remove the device. Place the test device on a clean, flat surface.
- Be sure to label the device with the specimen’s ID Number.
For Whole Blood Test
- Dispense 1 drop (about 30μL) of the specimen into the sample well,
- Then add 2 drops (about 60μL) of buffer immediately For serum or plasma test
- Dispense 1 drop (about 30μL) of the specimen into the sample well,
- Then add 2 drops (about 760-70 μL) of buffer immediately
Set up a timer.
• Results can be read in 20 minutes. Positive results can be visible in as
short as 1 minute.
• Don’t read results after 20 minutes. To avoid confusion, discard the test
device after interpreting the result.
INTERPRETATION OF RESULTS
NEGATIVE RESULT:
- If only the C band is present, the absence of any burgundy color in both T bands (T1 and T2) indicates that no HIV antibodies are detected in the specimen.
POSITIVE RESULT:
-
In addition to the presence of the C band, if the T1 band is developed, the test indicates the presence of antibodies to HIV-1 or HIV-2 in the specimen.
-
The result is HIV-1/HIV-2 positive.
-
In addition to the presence of the C band, if the T2 band is developed, the test indicates the presence of antibodies to HIV-O in the specimen. The
-
the result is HIV-O positive.
-
In addition to the presence of the C band, if both T1 and T2 bands are developed, the test
-
indicates the present antibodies to HIV 1/2 and HIV 0. The rest result is HIV positive. To differentiate
-
the type of virus infection, dilute the specimen at 1:100 dilution with the buffer provided, re-run
-
the test. Interpret the result as illustrated above (also See Limitations of Test 5.).
-
Samples with positive results should be confirmed with alternative testing method(s) and clinical findings
-
before a positive determination is made.
INVALID RESULT: -
If no C band is developed, the assay is invalid regardless of any burgundy color in the T bands as indicated below. Repeat the assay with a new device.
LIMITATIONS
-
The Assay Procedure and the Test Result Interpretation must be followed closely when testing the presence of antibodies to HIV in serum or plasma from individual subjects. Failure to follow the procedure may give inaccurate results.
-
The HIV 1/2/0 Antibody Rapid Test is limited to the qualitative detection of antibodies to HIV-1/2 or HIV-O in human
serum, plasma, or whole blood. The intensity of the test band does not have a linear correlation with the antibody titer in the specimen. -
A negative result for an individual subject indicates the absence of detectable HIV-1/2 or HIV-O antibodies. However, a negative test result does not preclude the possibility of exposure to or infection with HIV-1 /2 or HIV-O.
-
a negative result can occur if the quantity of the HIV-1 /2 or HIV-O antibodies present in the specimen is below the detection limits of the assay or the antibodies that are detected are not present during the stage of disease in which a sample is collected.
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As illustrated in INTERPRETATION OF ASSAY RESULT-2.3, all the three positive bands (T1, T2, and C) may develop when tested with samples containing a high titer of HIV-1/2 antibodies. To differentiate the cross-reactivity: dilute the test specimen with buffer at 1: 100 dilution, then re-test the diluted specimen with a new test device. Only T1 band and C will appear if it is an HIV-1/2Ab response. If T1, T2, and C bands all appear, the test indicates the exposure of both HIV-1 /2 and HIV-O.
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Some specimens containing unusually high titer of heterophile antibodies or rheumatoid factor may affect expected results.
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The results obtained with this test should only be interpreted in conjunction with other diagnostic procedures and clinical findings.