INTENDED USE

The HIV-1/2 Rapid Screen Test (RST) is a qualitative test for the detection of antibodies to Human Immunodeficiency Virus type 1 and 2(HIV-1/2) in human serum/plasma and whole blood. It is considered as an initial screening test for HIV-1/2 antibodies. All positive specimens must be confirmed with Western Blot or other qualified EIA.

 

PRECAUTION

1. For in vitro diagnostic uses only.
2. All patient samples should be treated as if capable of transmitting diseases.
3. Do not use test kit beyond expiration date.
4. Icteric, lipemic, hemolysed, heat treated and contaminated sera may cause erroneous results.

 

SUMMARY AND EXPLANATION OF THE TEST

It has been shown that the acquired immunodeficiency syndrome (AIDS) is caused by viruses transmitted by sexual contact, transfusion, use of contaminated blood products and sharing contaminated needles. HIV-1 and HIV-2 viruses have been isolated from patients with AIDS and AIDS-related complex (ARC), high-risk persons for AIDS. HIV-1 and HIV-2 viruses delete T helper cells, a subpopulation of T cells for body defense, thus causing AIDS patients susceptible to opportunistic infections and developing malignant tumors. The incidence of specific antibodies to HIV-1/2 is high in AIDS, ARC and persons with high risk for AIDS. The HIV-1/2 Rapid Screen Test is designed to detect antibodies to HIV-1/2 in AIDS patients, ARC or high risk persons and identify any potential donors carrying these antibodies in serum specimens.

 

PRINCIPLE

HIV-1/2 RST is a chromatographic immunoassay (CIA) for the detection of antibodies to HIV-1/2 in human serum/plasma and whole blood. HIV-1/2 specific antigens are precoated onto membrane as a capture reagent on the test region. During the test, specimen is allowed to react with the colloidal gold particles, which have been labeled with HIV-1/2 specific antigens. Antibodies to HIV-1/2, if present, a red colored band will develop on the membrane in proportion to the amount of HIV-1/2 antibodies present in the specimen. Absence of this red colored band in the test region suggests a negative result. To serve as a procedural control, red colored band in the control region will always appear regardless the presence of antibodies to HIV-1/2.

 

MATERIALS SUPPLIED

1. One pouched cassette with desiccant.

2. Blood diluents in a dropper bottle, stored at 4-30°C.

3. One piece of operating instruction.

MATERIALS NOT PROVIDED BUT REQUIRED

1. Specimen collection container, either plastic or class.
2. Timer.
3. Disposable gloves.

 

SPECIMENS COLLECTION AND STORAGE

Fingers stick Specimens (Whole Blood)

1. Clean the area to be lanced with an alcohol swab.
2. Squeeze the end of the fingertip and pierce it with a sterile lancet.
3. Wipe away the first drop of blood with sterile gauze or cotton.
4. Use micropipette to obtain about 100ul fresh blood.

 

Plasma

1. Have a certified phlebotomist collect whole blood into a purple, blue or green top collection tube (containing EDTA, citrate or heparin, respectively) by veinpuncture.
2. Separate the plasma by centrifugation.
3. Carefully withdraw the plasma for testing, or label and store it at 2-8°C for up to two weeks. Plasma may be frozen at -20°C for up to one year.

 

Serum

1. Have a certified phlebotomist collect whole blood into a red top collection tube (containing no anticoagulants) by veinpuncture.
2. Allow the blood to clot.
3. Separate the serum by centrifugation.

1. Carefully withdraw the serum for testing or label and store it at 2-8°C for up to two weeks. Serum may be frozen at -20°C for up to one year.

 

ASSAY PROCEDURE

Add 1 drop (1 drop = 35µl) of sample (whole blood/serum/plasma) into the sample well. After all samples completely absorbed, add 1 drop of diluent. Observe the result in 5-15 minutes.

 

QUALITY CONTROL

An internal procedural control is included in the test. red line will appears in the control region (C).

 

INTERPRETATION OF RESULTS

 

Negative: No apparent band in the test region (T), only one red band appears in the control region (C). This indicates that no HIV1/2 antibodies have been detected.

 

Positive: In addition to the band in the control region (C), other one red band will appear in the test region (T). This indicates that the specimen contains HIV1/2 antibodies.

 

Invalid: If no band appears in the control region(C), regardless of the presence or absence of line in the test region (T). It indicates a possible error in performing the test. The test should be repeated using a new device.

 

PERFORMANCE CHARACTERISTICS

 

Clinical Study

27689 HIV diagnostic samples were tested with the HIV-1/2 Rapid Screen Test. The results are summarized in the table below.

 

 

 

 

Diagnostic Sample type	Number of sample tested	HIV-1/2 Rapid Screen Test
		negative	Positive
Positive	651	0	651
Negative	27038	27013	25

Sensitivity=100%; Specificity=99.91%; Total accuracy=99.91%

 

Possible Interferences

The table below shows the results of the HIV-1/2 Rapid Screen Test on a variety of samples containing possibly interfering substances.

 

Sample type	Number of sample tested	HIV-1/2 Rapid Screen Test
		negative	Positive
Clinical specimens	200	200	0
Pregnant woman	200	200	0
Related infection(*)	100	98	2
Rheumatoid Factor positive	7	7	0
Multipara	1	1	0
Anti-Ecol positive	2	2	0

(*)The results were negative for samples containing HBsAg(15),anti-HCV(12),anti-HTLV(14),anti-VZV(4) and anti-EBV(4).1 of the 20 anti-CMV samples and 1 of the 15 anti-HAV samples were found false positive.

 

Precision

Intra-assay

In the study, 30 replicate assays were performed with one positive and one negative specimen. Correct negative and positive results were registered in 100% of the assays.

 

Inter-assay

The study involved the same specimens containing one positive and one negative. The samples were analyzed in 30 independent assays with HIV-1/2 Rapid Screen Test. originating from three different lots at different times during two months. Again, expected negative and positive results were registered in 100% of the assays.

 

STORAGE AND STABILITY

Store HIV-1/2 Rapid Screen Test at temperature ranges 4-30 °C in the sealed pouch. Refer to the expiration date for stability. Do not freeze.

 

LIMITATION

1. The test is to be used for the qualitative detection of antibodies to HIV.

1. A negative result does not rule out infection by HIV because the antibodies to HIV may be absent or may not be present in sufficient quality to be detected at early stage of infection.
2. A positive result, even a weak positive, must be verified with a confirmation test.
3. As with all diagnostic tests, the result must be correlated with clinical findings. If the test result is negative and suspicion still exists, additional follow-up testing using other clinical methods is recommended.

 

 

 

 

 

 

 

 

 

INDEX OF SYMBOLS

Do not re-use manufacture

For In-Vitro Diagnostic use only

Stored at Room Temperature

Attention: See instruction for use

Authorized Representative in the European Company

Use by (Expiration date) Lot number

 

REFERENCE

1. Centers for Disease control: Provisional Public Health Service inter-agency recommendations for screening donated blood and plasma for antibody to the virus causing acquired immunodeficiency syndrome. Morbidity and Mortality Weekly Rep 34: 5-7, 1985.

2. Coffin J, Haase A, Levy JA, et al: What to call the AIDS virus? Nature 321: 10, 1986

3. Popovic, M., et al: Detection isolation and continuous production of Cytopathic Retroviruses (HTLV.Ⅲ) from patients with AIDS and pre-AIDS. Science 1984; 224:497

4. Carison, J. R. et al: AIDS serology testing in low and high risk groups.JAMA1985; 253:3405

5. Centers for Disease contro,Update on Acquired Immune Deficiency Syndrome(AIDS)MMWR 1982; 31:507

6. Gallo, RC, et al: Frequent detection and isolation of Cytopathic Retroviruses (HTLV.Ⅲ) from patients with AIDS and a risk for AIDS.Science.1984; 224:500

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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Span Biotech Ltd. is a research based company for rapid tests, with strong support from National Key Laboratory of Technology Projects of 10^th and 11^th Five-Year Plan and Faculty of Life Sciences of HuBei University. SpanBio also housed a R&D team that is developing gene recombination, cell cultivation and protein purification techniques. SpanBio pays strict attention on rapid tests for human being, animal diseases and food safety detection. It provides a number of customized services to professional distributors and partnering affiliates with excellent quality, competitive prices and super service.

 

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