Comparative evaluation of TRI-DOT Rapid HIV test with fourth-generation ELISA for the detection of human immunodeficiency virus

Sudha, Talasila; Teja, Vijay Dharma; Gopal, Madhumita; Rajesh, Manchi; Lakshmi, V

doi:10.1111/j.1469-0691.2005.01231.x

Cited by 10 publications

(8 citation statements)

References 11 publications

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“…In a study of 23 609 samples comparing rapid test with fourth generation assay from a high prevalence (4·8%) region, six reactive samples exclusive to fourth generation assay were also confirmed by WB. The authors concluded that rapid tests were a suitable alternative for emergency situations (Sudha et al , ). Overall there is much confusion about donor prevalence due to wide variance in the test results and confirmatory algorithms.…”

Section: Efforts To Limit Tti Through Blood Screening In Indiamentioning

confidence: 99%

Transfusion transmitted infections in thalassaemics: need for reappraisal of blood screening strategy in India

Shyamala

2014

Transfusion Medicine

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The aim of the study was to assess the blood safety in India through prevalence in thalassaemic population. Safety of the blood supply is a subject of great concern for all recipients. This review attempts to assess the relevance and format of tests for viruses in the context of transfusion transmitted infection (TTI) prevalence in India. Serological marker testing for human immunodeficiency virus-1/2 (HIV-1/2), hepatitis C virus (HCV) and hepatitis B virus (HBV) is mandatory in India. Numerous TTI incidents in the repeat recipients supported by results from nucleic acid technology (NAT) testing indicate the deficiencies in blood safety. The β-thalassaemic population (3-17%) in India has been used to reflect on blood safety. The prevalence of HIV-1/2, HCV and HBV in the Indian donor population, the limitations in accessing safe donors, quality of serological tests and the impact on repeat recipients is evaluated. The reports point to prevalence of ˜2% of viral diseases in the blood donor population, and the insufficiency of serology testing resulting in up to 45% TTIs in thalassaemics. The revelation by individual donation (ID) NAT testing, of 1 per 310 units being serology negative-NAT reactive is alarming. Extrapolating the serology negative NAT reactive yields, for an annual blood supply of 7.9 million units, 23,700 units or nearly 100,000 blood components are likely to be infectious. Though the cost for ID-NAT testing is considered unaffordable for a medium development country such as India, the enormity of TTIs will place an unmanageable cost burden on the society.

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Section: Efforts To Limit Tti Through Blood Screening In Indiamentioning

confidence: 99%

Transfusion transmitted infections in thalassaemics: need for reappraisal of blood screening strategy in India

Shyamala

2014

Transfusion Medicine

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“…That could be the possible reason why HIV TRI-DOT missed them for HIV-2. The false negativity of HIV-2 with HIV TRI-DOT BIOMED must be severely taken into account because: 1) there is a high degree of chance to miss HIV-2 infection in any patient who is infected with HIV-2 alone or combined with HIV-1; 2) the assay is widely used in this country (5,15); and 3) treatment regimens are also specific to HIV subtypes (21,22,23). Out of these seven specimens, five were HIV-2-indeterminate, all had p26 band, and two specimens had gp105/ 125 in addition to p26.…”

Section: Discussionmentioning

confidence: 99%

Performance characteristics of a new rapid immunochromatographic test for the detection of antibodies to human immunodeficiency virus (HIV) types 1 and 2

Iqbal

Balakrishnan

Murugavel

et al. 2008

Clinical Laboratory Analysis

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Diagnostic kits for the detection of human immunodeficiency virus (HIV) antibodies have reached an unprecedented number. But choice of an ideal, cost-effective, and rapid test for HIV infection is of immense value for use in developing countries like India, where resources are limited. In this study we have evaluated the performance characteristics of the rapid immunochromatographic HIV test kit First Response HIV 1-2.O. First, the laboratory archived 450 characterized plasma/serum specimens, which were tested on First Response HIV 1-2.O. Second, a total of 134 consecutive voluntary counseling and testing (VCT) specimens were also tested and positive specimens were further confirmed with HIV TRI-DOT. All these VCT specimens were cross-checked with HIV double-enzyme-linked immunosorbent assay (ELISA) (Murex and Vironostika), and the results were matched. The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and efficiency of First Response HIV 1-2.O with the 450 characterized specimens was 100% for HIV-1 with reference assay. The results in the VCT algorithm were correlating with double-ELISA. In the HIV-2 analysis, five HIV-2-positive specimens in First Response HIV 1-2.O were found to be HIV-2-indeterminate on Western blot. HIV TRI-DOT was unable to pick up two HIV-2 Western blot-positive specimens. First Response HIV 1-2.O has several advantages: low-cost (U.S. $0.70); only 10 microL of specimen; involves only two steps; room temperature storage; ability to differentiate HIV-1 and 2; and use of whole blood specimen. Hence this test kit could be suitable for initial screening in the HIV testing algorithm in resource-limited settings. J. Clin. Lab. Anal. 22:178-185, 2008. (c) 2008 Wiley-Liss, Inc.

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“…shows the results of various studies from India estimating HIV seroprevalence. [1011121314151617] In a previous study from our institute, Sharma et al ., screened 2, 35,461 donors between 1996 and 2002 using third generation ELISA. The prevalence of HIV ranged from 0.16% in 1996 to 0.3% in 2002.…”

Section: Discussionmentioning

confidence: 99%

“…Sudha, et al ., evaluated the TRI-DOT Rapid HIV test for the early detection of human immunodeficiency virus (HIV) infection in comparison with a 4 th generation ELISA (Vironostika HIV Uniform II) in 23609 samples between January 2003 and April 2004. [17] In the case of discordance, sera were retested by Western Blot, and qualitative RT-PCR. The overall prevalence of HIV-1 and HIV-2 in the sera studied was 4.7% and 0.2%, respectively, and 19 (1.7%) of the 1150 HIV-reactive patients were infected with both HIV-1 and HIV-2.…”

Section: Discussionmentioning

confidence: 99%

Seroprevalence of human immunodeficiency virus in north Indian blood donors using third and fourth generation Enzyme linked immunosorbent assay

Malhotra¹,

Marwaha²,

Saluja³

2013

Asian J Transfus Sci

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Background:The percentage of HIV cases attributable to blood transfusion has decreased significantly in the last decade. The newer 4th generation Enzyme linked immunosorbent assay (ELISA) has been shown to have increased sensitivity compared to 3rd generation ELISA.Objectives:To estimate the seroprevalence of HIV among blood donors using 4th generation ELISA assay and to compare it with the 3rd generation ELISA.Materials and Methods:This prospective study involved 10,200 blood donors- 6,800 were voluntary donors (3400-students and 3400-non students) and 3400 were replacement donors. All blood units were tested with 3rd as well as 4th generation ELISA. All samples found reactive or in grey zone with either 3rd or 4th generation ELISA were retested by Western blot (WB).Results:The seroprevalence of HIV was estimated to be 1.37/1000 donations (0.14%) with 3rd generation ELISA compared to 3.62/1000 donations (0.36%) with 4th generation ELISA (p>0.05). The seroprevalence of HIV among voluntary donors was estimated to be 1.32/1000 donations (0.13%) with 3rd generation ELISA and 3.67/1000 donations (0.36%) with 4th generation ELISA. The prevalence of HIV among replacement donors was 1.47/1000 donations (0.15%) with 3rd generation ELISA and 3.52/1000 donations (0.35%) with 4th generation ELISA.Conclusion:4th generation HIV ELISA detects a higher number of seroreactive donors compared to 3rd generation ELISA. However, larger studies are required with confirmatory tests for both 3rd and 4th generation ELISA for making any policy changes.

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Comparative evaluation of TRI-DOT Rapid HIV test with fourth-generation ELISA for the detection of human immunodeficiency virus

Cited by 10 publications

References 11 publications

Transfusion transmitted infections in thalassaemics: need for reappraisal of blood screening strategy in India

Transfusion transmitted infections in thalassaemics: need for reappraisal of blood screening strategy in India

Performance characteristics of a new rapid immunochromatographic test for the detection of antibodies to human immunodeficiency virus (HIV) types 1 and 2

Seroprevalence of human immunodeficiency virus in north Indian blood donors using third and fourth generation Enzyme linked immunosorbent assay

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