Blinded, multicenter quality control study for the quantification of human immunodeficiency virus type 1 RNA in plasma by the Belgian AIDS reference laboratories

Muyldermans, Gaëtan; Debaisieux, Laurent; Fransen, Katrien; Marissens, D.; Miller, Kirk D.; Vaira, Dolorès; Vandamme, Anne‐Mieke; Vandenbroucke, Anne-Thérèse; Verhofstede, Chris; Schuurman, Rob; Zissis, Georges; Lauwers, S.

doi:10.1046/j.1469-0691.2000.00048.x

Cited by 24 publications

(10 citation statements)

References 23 publications

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“…Our rate of 3.7% inhibited tests is in good concordance with the few previous studies that have addressed this issue systematically (15,(31)(32)(33)(34). The accuracy of our assay was equivalent to or better than values observed in earlier studies on commercial and in-house viral-load assays (28,(35)(36)(37), and the good analytical sensitivity of our assay allowed a broad quantification range covering the range of viral loads in both treated and untreated patients.…”

Section: Discussionsupporting

confidence: 89%

Ultrasensitive Monitoring of HIV-1 Viral Load by a Low-Cost Real-Time Reverse Transcription-PCR Assay with Internal Control for the 5′ Long Terminal Repeat Domain

et al. 2006

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Background: Current HIV-1 viral-load assays are too expensive for resource-limited settings. In some countries, monitoring of antiretroviral therapy is now more expensive than treatment itself. In addition, some commercial assays have shown shortcomings in quantifying rare genotypes. Methods: We evaluated real-time reverse transcription-PCR with internal control targeting the conserved long terminal repeat (LTR) domain of HIV-1 on reference panels and patient samples from Brazil (n ‫؍‬ 1186), South Africa (n ‫؍‬ 130), India (n ‫؍‬ 44), and Germany (n ‫؍‬ 127). Results: The detection limit was 31.9 IU of HIV-1 RNA/mL of plasma (>95% probability of detection, Probit analysis). The internal control showed inhibition in 3.7% of samples (95% confidence interval, 2.32%-5.9%; n ‫؍‬ 454; 40 different runs). Comparative qualitative testing yielded the following: Roche Amplicor vs LTR assay (n ‫؍‬ 431 samples), 51.7% vs 65% positives;

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Section: Discussionsupporting

confidence: 89%

Ultrasensitive Monitoring of HIV-1 Viral Load by a Low-Cost Real-Time Reverse Transcription-PCR Assay with Internal Control for the 5′ Long Terminal Repeat Domain

et al. 2006

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“…For instance, a single HPV detection method used by seven laboratories demonstrated several orders of magnitude of variation in sensitivity for HPV 16 detection. Similar observations have been reported in proficiency studies of hepatitis B (36), hepatitis C (20), HIV (19,29), herpes simplex virus (28), and Chlamydia trachomatis (39) using nucleic acid detection. These data underscore the need to critically consider information on HPV type-specific prevalence in epidemiology studies and point to the utility of developing HPV DNA standards.…”

Section: Discussionsupporting

confidence: 86%

Results of the First World Health Organization International Collaborative Study of Detection of Human Papillomavirus DNA

et al. 2006

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Twenty-nine laboratories in 12 countries participated in a study to assess the performance of various human papillomavirus (HPV) detection assays through the use of a recombinant HPV DNA standard reagent panel. Human papillomavirus (HPV) infection has been established as the major cause of cervical cancer in women (40,46). Among the nearly 100 types of papillomaviruses molecularly identified, about 30 different HPV types are found in cervical carcinomas (18). Epidemiological studies on the global prevalence of HPV types have shown that about 70% of cervical cancer cases are related to infections with two high-risk (HR) HPV types, namely HPV 16 and HPV 18. About 15% are related to HR HPV types 31, 33, 35, 45, 52, and 58, collectively, and approximately 15% are related to other less common types, with some geographical variations (2). Thus, to prevent cervical cancer, several candidate vaccines against HPV have been developed and are currently in clinical testing (5). Prophylactic HPV vaccine candidates are based on recombinant virus capsid proteins, so-called virus-like particles, and are designed to prevent infections by HPV types 16 and 18, the most common oncogenic types, as well as against the common types HPV 6 and HPV 11 that cause genital warts (1,8,16).It was recognized by a group of HPV experts that harmonization of HPV laboratory assays was required at the outset of the development and implementation of new HPV vaccines (41). The World Health Organization (WHO) establishes international biological standard materials and reference reagents for substances of biological origin used in prophylaxis and in therapy or diagnosis of human diseases. Hence, an international collaborative study was conducted to consider candidate reference reagents for type-specific HPV DNA assays (42,43).To assess the relative value of molecular detection methods, international proficiency panels are already widely used for several microorganisms including hepatitis A, B, and C and human immunodeficiency virus (HIV) (23,24,26,36). Unfortunately, there is no natural source of biological material to generate type-specific HPV standard reagents such as naturally infected or spiked serum or plasma pools used for hepatitis and HIV standards. Cervical scrapes or small genital biopsy specimens obtained for diagnosis of HPV-infected individuals often harbor multiple HPV types and provide only low numbers of HPV genomes. In addition, no adequate culture models or human cell lines containing episomal HPV genomes are readily available to generate reproducible epithelial cell-based HPV standards.The present international collaborative study was initiated to assess the performance of various HPV DNA detection assays and to examine the feasibility of generating HPV DNA standard reagents consisting of recombinant HPV DNA plasmids placed into a background of HPV-negative human cervical cells. Cloned HPV DNA standards such as those described here allow assessment of the analytic HPV assay sensitivity and

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“…We found a fair homogeneity of results of assays evaluated at a theoretical level of 3.0 log 10 copies/ml and a decreasing accuracy and reproducibility of assays with decreasing viral loads, as previously shown in a quality control study of HIV-1 RNA quantification assays (6). Overall, four laboratories systematically overquantified viral loads, no.…”

Section: Human Immunodeficiency Virus Type 2 (Hiv-2) Rna Quantificatisupporting

confidence: 74%

Quality Control Assessment of Human Immunodeficiency Virus Type 2 (HIV-2) Viral Load Quantification Assays: Results from an International Collaboration on HIV-2 Infection in 2006

et al. 2008

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Human immunodeficiency virus type 2 (HIV-2) RNA quantification assays used in nine laboratories of the ACHI E V 2E (A Collaboration on HIV-2 Infection) study group were evaluated. In a blinded experimental design, laboratories quantified three series of aliquots of an HIV-2 subtype A strain, each at a different theoretical viral load. Quantification varied between laboratories, and international standardization of quantification assays is strongly needed.

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Blinded, multicenter quality control study for the quantification of human immunodeficiency virus type 1 RNA in plasma by the Belgian AIDS reference laboratories

Cited by 24 publications

References 23 publications

Ultrasensitive Monitoring of HIV-1 Viral Load by a Low-Cost Real-Time Reverse Transcription-PCR Assay with Internal Control for the 5′ Long Terminal Repeat Domain

Ultrasensitive Monitoring of HIV-1 Viral Load by a Low-Cost Real-Time Reverse Transcription-PCR Assay with Internal Control for the 5′ Long Terminal Repeat Domain

Results of the First World Health Organization International Collaborative Study of Detection of Human Papillomavirus DNA

Quality Control Assessment of Human Immunodeficiency Virus Type 2 (HIV-2) Viral Load Quantification Assays: Results from an International Collaboration on HIV-2 Infection in 2006

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