Anti-HIV Triline Cassette Performance Characteristics

No standards for performance have yet been established for HIV rapid assays. The
Serum/Whole Blood Test HIV-1 / HIV-2 test has been tested against a commercially available HIV
EXPLANATION OF THE TEST panel with a commercially available ELISA HIV assay. All samples in the HIV
HIV-1 has been isolated from patients with AIDS and AIDS panel detected as positive by the ELISA assay were also detected by IND
related complex, and from healthy persons with high potential risk HIV-1/HIV-2 as positive. No cross reactivity or interference was detected from
of developing AIDS. Patients with HI V-2 are found primarily in other antigens, lipemic, or icteric samples.
parts of West Africa. HIV-1 and HIV-2 are similar in their Clinical Trials:
morphology, cell tropism, host interaction and generic structure. To establish the sensitivity and specificity of IND Diagnostics Anti-HIV(1+2) Whole
Blood/Serum/Plasma test kit, 505 clinic samples were studied. Another commercially
Serological studies have determined that HIV-1 and HIV-2 have o
temperature is significantly lower than 15 C, then the interpretation available qualitative test kit was used to compare with IND Diagnostic Anti-HIV whole
multiple common epitopes in core antigens but much less so in the time should be properly increased. blood/serum test kit for relative sensitivity and specificity in 505 samples. Only 3 samples
envelope antigens. were discordant. In turn, the agreement is 99.4%. The results are shown in Table 1.

The HIV-1/HIV-2 test is a solid phase immunochromatographic Comparison of Anti-HIV 505 cases
assay for the qualitative detection of antibodies against HIV-1 and
HIV-2. This test is intend for professional use as an aid on the
Results of IND kits
diagnostis of HIV-1/HIV2. C T2 T1 C T2 T1 C T2 T1 C T2 T1 Subtotal
+ -
MATERIALS PROVIDED Negative HIV1 Positive HIV2 Positive HIV 1&2 Positive
1. HIV ½ test device. Results of + 78 1 79
2. Instructions. Commercial
3. Disposable sample droppers. kits - 2 424 426
4. Dilution Buffer. Subtotal 80 425 505
C T2 T1
PRECAUTIONS Invalid
The HIV-1 / HIV-2 Test devices should be stored at 4 to Clinical Specificity:
30oC (40-86oF). The test device is sensitive to humidity as well as Clinical Specificity is defined as the probability of a negative result in the absence of the
to heat. Perf orm the test immediately after removing the test INTERPRETATIO N OF RESULTS particular condition. Clinical Specificity was determined by assaying blind-coded Anti-
device from the foil pouch. Do not use it beyond the expiration. HIV negative samples. We classified as negative a sample that when tested with the
IND Diagnostic Anti-HIV whole blood / serum Test showed only one colored
SPECIMEN COLLECTION AND STORAGE ¾ Negative: Only one colored band appears on the control band on Control Region.
1. The test must be performed using human serum/plasma or (C)) region. No apparent band on the test (T2 and T1)
Clinical Specificity = TN ÷ (TN+FP), where TN: True Negative, and FP: False Positive
whole blood. region. Clinical SpecifIcity = 424 ÷ (424+2) = 99.5%
2. If specimens are not immediately tested they should be
refrigerated at 2-8 oC. For storage periods greater than three ¾ HIV 1Positive: In addition to a pink colored control C band,a Clinical Sensitivity:
days, freezing is recommended. They should be brought to distinct darker pink colored band will appear in the test T1 Clinical SensitivIty is defined as the probability of a positive result in the presence of the
room temperature prior to use. Whole blood cannot be stored region. A light pink color band might appear in the T2 particular condition. Clinical SensitivIty was determined by Assaying blind-coded Anti-
Iin freezer. region. HIV positive samples. We classified as Positive a sample that when tested with the IND
3. Specimens containing precipitate may yield inconsistent test Diagnostic Anti-HIV whole blood / serum Test showed only one colored
results. Such specimens must be clarified prior to assaying. band on the Control Region and one color band on the Test Region 1 and/or one color
¾ HIV 2 Positive: In addition to a pink colored control (C) band, band on the Test Region 2.
WARNINGS a distinct darker pink colored band will appear in the test T2) Clinical sensitivIty = TP ÷ (TP+FN), where TP: True Positive, FN: False Negative
Clinical SensitivIty = 78 ÷ (78+1) = 98.7%
1. For in vitro diagnostic use only. region. A light pink color band might appear in the T1 region.
2. Do not eat or smoke while handling specimens. References
3. Wear protective gloves while handling specimens. Wash ¾ Both HIV 1 and 2 positive: In addition to a pink colored Caetano JA Immunologic aspects of HIV infection. Acta Med Port (1991) 4 Suppl 1:52S-
hands thoroughly afterwards. 58S
control (C) line, a distinct pink colored band will appear in Janssen, RS, Satten, GA, Stramer, SL, Rawal, BD, O’ Br
ien, TR, Weiblen, BJ, Hecht, FM,
4. Avoid splashing or aerosol formation. both of the T1 and T2 region at the same time. Jack, N, Cleghorn, FR, Kahn, JO, Chesne÷, MA and Busch MP. New testing strateg÷ to
5. Clean up spills thoroughly using an appropriate disinfectant. detect earl÷ HIV-1 infection for use in incidence estimates and for clinical and prevention
6. Decontaminate and dispose of all specimens, reaction kits ¾ Invalid: A total absence of color in both regions or no colored purpose. JAMA (1998) 280(1):42-48
and potentially contaminated materials, as if they were line appears in the control (C) region is an indication of Lee Ratner, W illiam Haseltine, Roberto Patarca, etc.: Complete nucleotide sequence of
infectious waste, in a biohazard container. the AIDS virus, HTL V-III. Nature VOL. 313, 24 Januar÷ 1985
7. Do not use the test kit if the pouch is damaged or the seal is procedure error and/or test reagent deterioration. M.S.Saac, M.Holodni÷, D.R. Kuritzhes, etc.: HIV viral load markers in clinical practice.
broken. Nature Medicine, Volume 2, Number 6, June 1996.
Mi Jin Sohn, Young Hae Chong, Ji Eun Chang, Young Ik Lee : Overexpression and
Limitations of the Test simple purification of human immunodeficienc÷ virus-a gag epitope derived from a
PROCEDURE recombinant antigen in E. coli and its use in ELISA. Journal of Biotechnolog÷ 34 (1994)
1. Remove the test disk from the foil pouch, and place it on a Although a positive result may indicate infection with HIV-1 or HIV-2 virus, 149-155
flat, dry surface. a diagnosis of HIV infection can only be made on clinical grounds, if an Travers, K, Mboup, S, Marlink, R, Gue÷e-Nida÷e, A, Sib÷, T, Thior, I, Traore, I, Dieng-
2. Holding the sample dropper above the test disk slowly add 1 individual meets the case definition for HIV infection established by the Sarr, A , Sankale, JL and Mullins, C. Natural protection against HIV-1 infection provided
Ddrop of sample into the sample well ( Figure 1), then add b÷ HIV-2. Science (1995) 268:1612-1615
Centers for Disease Control. For samples repeatedly testing positive, more V.S. Ivanov, Z.K. Suvorova, L.D. Tchikin, A.T. Kozhich and V.T . Ivanov : Effective
2 2 drops of dilution buffer specific supplemental tests must be performed. Immuno-chromatographic method for s÷nthetic peptide immobilization that increases the sensitivit÷ and specificit÷
3. As the test begins to work, you will see purple color move of ELISA procedures. Journal of Immunological methods, 153 (1992) 229-233
across the Result Window in the center of the Test Disk. testing alone cannot be used to diagnose HIV infection even if the antibodies
4. Interpret test results at 15 to 30 minutes.
inutes. Do not interpret test against HIV-1/HIV-2 are present in patient specimen. A negative result at
result after 30 minutes.
inutes. any time does not preclude the possibility of HIV-1 / HIV-2 infection.
Caution: The above interpretation time is based on reading the test The HIV 1/ 2 rapid test is only used for the HIV antibodies screening test, the
results at room temperature of 15 to 30 oC. I f your room final diagnosis of HIV infection should be definite by the confirmation test.
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