Multicenter Evaluation Of Quantification Methods For Plasma Human Immunodeficiency Virus Type 1 Rna

Lin, Hsiang Ju; Myers, Lawrence E.; Yen‐Lieberman, Belinda; Hollinger, F. Blaine; Henrard, Denis; Hooper, Carol J.; Kokka, Robert; Kwok, Shirley; Rasheed, Suraiya; Vahey, Maryanne; Winters, Mark A.; McQuay, Lisa J.; Nara, Peter L.; Reichelderfer, Patricia; Coombs, Robert W.; Jackson, J. Brooks

doi:10.1093/infdis/170.3.553

Cited by 131 publications

(55 citation statements)

References 25 publications

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“…p24 antigenemia has already been reported by many other authors (Winters et al 1993, Lin et al 1994, van Karkhoven et al 1994, Coste et al 1996. These results clearly showed the higher sensivity of viral load determination in comparison with p24 antigen detection.…”

Section: Discussionsupporting

confidence: 65%

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Quantitation of HIV-1 RNA Viral Load Using NASBA Methodology and Comparison with other Surrogate Markers for Disease Progression

Sitnik¹,

Pinho

1998

Mem. Inst. Oswaldo Cruz

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Section: Discussionsupporting

confidence: 65%

“…Conversely, other authors previously reported an inverse correlation between CD4 counts and HIV-1 RNA level (Winters et al 1993, Lin et al 1994, van Karkhoven et al 1994, Coste et al 1996. ß-2 microglobulin did not provide additional prognostic information and was found to be a non-specific marker of immune activation (Mellors et al 1997).…”

Section: Discussionmentioning

confidence: 90%

Quantitation of HIV-1 RNA Viral Load Using NASBA Methodology and Comparison with other Surrogate Markers for Disease Progression

Sitnik¹,

Pinho

1998

Mem. Inst. Oswaldo Cruz

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“…Using the HIV-CheX or Genscreen kit with any other kit would be an ineffective combination. One notable issue here is the discordance between the results of two assays (6,8,14), which can be resolved if better kits are used. Hence, this kind of evaluation gains importance for determining a better choice of kits.…”

Section: Discussionmentioning

confidence: 99%

Evaluation and Diagnostic Usefulness of Domestic and Imported Enzyme-Linked Immunosorbent Assays for Detection of Human Immunodeficiency Virus Type 1 Antibody in India

Iqbal

Solomon

Murugavel

et al. 2005

Clin Vaccine Immunol

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Diagnosis of human immunodeficiency virus (HIV) infection is importantInfection with human immunodeficiency virus (HIV) has become pandemic since its first documentation in 1981 and is a major public health concern (11). HIV antibody testing is critical for the diagnosis and counseling of HIV-infected persons, the monitoring of trends in HIV prevalence, and the evaluation of the effectiveness of HIV prevention programs (5,12). An unprecedented number of tests for the detection of HIV antibodies are available. In some kits, improved sensitivity is frequently accompanied by a decreased specificity. This has been of particular concern with the introduction of test kits that detect all isotypes of antibodies, such as those based on antibody capture by antigens on a solid phase with labeled antigens as the detecting reagents (4,8).In resource-poor developing countries, the surveillance and diagnosis of HIV infection are major challenges (15). The conventional algorithm for HIV diagnostic testing consists of screening with enzyme immunoassays followed by confirmation with a Western blot test. Moreover, a double enzymelinked immunosorbent assay (ELISA) without Western blotting has been accepted as the customary screening assay for HIV infection (18). Because of the high cost of the Western blot test, it has not been affordable in a number of laboratories in developing countries (1). Rapid screening for HIV infection performed on-site with tests that do not require expensive laboratory infrastructure or highly skilled personnel helps with the diagnoses of patients in emergencies (13). The present study has been designed to evaluate five different commercially available diagnostic ELISA kits, and also a rapid test kit, for their performance in diagnosing HIV infection. MATERIALS AND METHODSThis study was carried out at the Y. R. Gaitonde Centre for AIDS Research and Education (YRG CARE) in Chennai, India; it is a referral center for voluntary counseling and testing (VCT) in South India. A total of 264 specimens (plasma and serum) collected from VCT clients were tested using various commercial HIV ELISA kits, and the positive specimens were confirmed by Western blot analysis (Genetic Systems HIV-1 Western blot; Bio-Rad Laboratories, Redmond, WA). The following commercially available ELISA kits were employed in this study: Enzaids HIV 1ϩ2 (Span Diagnostics Ltd., Surat, India), HIV-CheX (Xcyton Diagnostics Ltd., Bangalore, India), Murex HIV-1.2.0 (Murex Biotech Limited, Dartford, United Kingdom), Genscreen HIV 1/2 version 2 (Bio-Rad Laboratories, France), and Vironostika HIV Uni-Form II Ag/Ab (BioMérieux, The Netherlands). Along with these, a rapid test kit, CombAids RS Advantage (Span Diagnostics Ltd., Surat, India), was also evaluated. A double-blind format was adopted in order to conceal patient information from the testing personnel. One staff member generated duplicate numbers for specimens at the specimen processing section; a second staff member generated plate maps and performed the tests. Finally, the results were ...

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“…The reported data were evaluated with the respect to the ability of the participants to obtain VL testing results that reproduce the known concentrations of HIV-1 RNA present in each DTS PT panel member. The results reported from the participants were grouped and analyzed by type of VL assay to avoid possible variability of the results among different types of VL assays (12)(13)(14). These groups were formed by a minimum of six participants using the same assay in each PT testing cycle.…”

Section: Methodsmentioning

confidence: 99%

Monitoring the Quality of HIV-1 Viral Load Testing through a Proficiency Testing Program Using Dried Tube Specimens in Resource-Limited Settings

et al. 2015

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HIV-1 viral load (VL) levels are used for monitoring disease progression and antiretroviral therapy outcomes in HIV-infected patients. To assess the performance of laboratories conducting HIV-1 VL testing in resource-limited settings, the U.S. Centers for Disease Control and Prevention implemented a voluntary, free-of-charge, external quality assurance program using dried tube specimens (DTSs). Between 2010 and 2012, DTS proficiency testing (PT) panels consisting of 5 specimens were distributed at ambient temperature to participants. The results from the participants (n > 6) using the same assay were grouped, analyzed, and graded as acceptable within a group mean ؎ 3 standard deviations. Mean proficiency scores were calculated by dividing the combined PT scores by the number of testing cycles using a linear regression model. Between 2010 and 2012, the number of participants enrolled increased from 32 in 16 countries to 114 in 44 countries. A total of 78.2% of the participants reported results using 10 different VL assays. The rates of reporting of acceptable results by the participants were 96.6% for the Abbott assay, 96.3% for the Roche Cobas assay, 94.5% for the Roche Amplicor assay, 93.0% for the Biocentric assay, and 89.3% for the NucliSens assay. The overall mean proficiency scores improved over time (P ‫؍‬ 0.024). DTSs are a good alternative specimen type to plasma specimens for VL PT programs, as they do not require cold chain transportation and can be used on PCR-based assays. Our data suggest that the CDC HIV-1 VL PT program using DTSs positively impacts the testing performance of the participants, which might translate into better and more accurate VL testing services for patients.H igh-quality clinical laboratories are urgently needed to sustain global efforts to expand the number of individuals infected with human immunodeficiency virus (HIV) receiving antiretroviral therapy (ART) (1). At the end of 2012, over 35 million people were estimated to be living with HIV, with more than twothirds of new HIV infections occurring in sub-Saharan Africa (2). Worldwide, ART has been shown to effectively reduce the rates of morbidity and mortality associated with AIDS (3). Quantitation of HIV-1 viral loads (VLs) has become the standard of care for monitoring the response to ART in HIV-infected patients, understanding disease progression, and preventing HIV transmission (4, 5). On the basis of the World Health Organization (WHO) 2010 treatment guidelines, which recommended initiating ART at a CD4 count threshold of 350 cells/mm 3 , it was estimated that over 8 million people in low-and middle-income countries were receiving ART in 2011 (6). The number of patients eligible for ART is expected to rise as countries adopt the new 2013 WHO treatment guidelines, which recommend a CD4 count threshold of 500 cells/mm 3 for initiation of ART (1), and the Joint United Nations Programme on HIV/AIDS (UNAIDS) Treatment 2015 plan, which calls for starting 15 million people on ART by 2015 (2). The President's Emergency Plan for ...

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Multicenter Evaluation Of Quantification Methods For Plasma Human Immunodeficiency Virus Type 1 Rna

Cited by 131 publications

References 25 publications

Quantitation of HIV-1 RNA Viral Load Using NASBA Methodology and Comparison with other Surrogate Markers for Disease Progression

Quantitation of HIV-1 RNA Viral Load Using NASBA Methodology and Comparison with other Surrogate Markers for Disease Progression

Evaluation and Diagnostic Usefulness of Domestic and Imported Enzyme-Linked Immunosorbent Assays for Detection of Human Immunodeficiency Virus Type 1 Antibody in India

Monitoring the Quality of HIV-1 Viral Load Testing through a Proficiency Testing Program Using Dried Tube Specimens in Resource-Limited Settings

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