Update on the laboratory diagnosis and monitoring of HIV infection

Constantine, Niel T.; Kabat, William; Zhao, Yuqi

doi:10.1038/sj.cr.7290361

Cited by 11 publications

(5 citation statements)

References 24 publications

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“…Initially, simple serologic tests for HIV antibodies using culture-derived viral antigen preparations were developed to diagnose HIV infections and to safeguard blood and blood product supplies (21). Over the next 3 decades, a wide spectrum of serologic assays was developed for simple/rapid testing (22,23), high-throughput screening (24,25), supplementary confirmation (26), epidemiological surveillance (27)(28)(29), and incidence determination (30)(31)(32)(33). Assays with different testing formats, antigen designs, and signal detection amplification chemistries were formulated and evaluated in the field to assess their testing accuracy, viral strain coverage, and field applicability to ensure that infected patients could be quickly and accurately identified and linked to health care services, with minimal loss to follow-up.…”

Section: Advances In Serologic Diagnosismentioning

confidence: 99%

Diagnosis of Human Immunodeficiency Virus Infection

Parekh

Fonjungo

et al. 2018

Clin Microbiol Rev

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SUMMARY HIV diagnostics have played a central role in the remarkable progress in identifying, staging, initiating, and monitoring infected individuals on life-saving antiretroviral therapy. They are also useful in surveillance and outbreak responses, allowing for assessment of disease burden and identification of vulnerable populations and transmission “hot spots,” thus enabling planning, appropriate interventions, and allocation of appropriate funding. HIV diagnostics are critical in achieving epidemic control and require a hybrid of conventional laboratory-based diagnostic tests and new technologies, including point-of-care (POC) testing, to expand coverage, increase access, and positively impact patient management. In this review, we provide (i) a historical perspective on the evolution of HIV diagnostics (serologic and molecular) and their interplay with WHO normative guidelines, (ii) a description of the role of conventional and POC testing within the tiered laboratory diagnostic network, (iii) information on the evaluations and selection of appropriate diagnostics, (iv) a description of the quality management systems needed to ensure reliability of testing, and (v) strategies to increase access while reducing the time to return results to patients. Maintaining the central role of HIV diagnostics in programs requires periodic monitoring and optimization with quality assurance in order to inform adjustments or alignment to achieve epidemic control.

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Section: Advances In Serologic Diagnosismentioning

confidence: 99%

Diagnosis of Human Immunodeficiency Virus Infection

Parekh

Fonjungo

et al. 2018

Clin Microbiol Rev

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“…CD4 cell count test has been used to determine when HIV infected patients should start antiretroviral therapy (ART) and to monitor ART [1][2][3][4][5][6][7]. CD4 cell count test has been key in predicting disease progression and death among people living with HIV, and it has been crucial for assessing eligibility of prophylaxis for opportunistic infections (OIs) [3,4].…”

Section: Introductionmentioning

confidence: 99%

Diagnostic performance and usability of the VISITECT CD4 semi-quantitative test for advanced HIV disease screening

Ndlovu

Massaquoi²,

Bangwen³

et al. 2020

PLoS ONE

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Background In sub-Saharan Africa, a third of people starting antiretroviral therapy and majority of patients returning to HIV-care after disengagement, present with advanced HIV disease (ADH), and are at high risk of mortality. Simplified and more affordable point-of-care (POC) diagnostics are required to increase access to prompt CD4 cell count screening for ambulatory and asymptomatic patients. The Visitect CD4 Lateral Flow Assay (LFA) is a disposable POC test, providing a visually interpreted result of above or below 200 CD4cells/mm 3. This study evaluated the diagnostic performance of this index test. Methods Consenting patients above 18years of age and eligible for CD4 testing were enrolled in Nsanje district hospital (Malawi), Gutu mission hospital (Zimbabwe) and Centre hopitalier de Kabinda (DRC). A total of 708 venous blood samples were tested in the index test and in the BD FACSCount assay (reference test method) in the laboratories (Phase 1) to determine diagnostic accuracy. A total of 433 finger-prick (FP) samples were tested on the index test at POC by clinicians (Phase 2) and a self-completed questionnaire was administered to all testers to explore usability of the index test. Results Among 708 patients, 67.2% were female and median CD4 was 297cells/mm 3. The sensitivity of the Visitect CD4 LFA using venous blood in the laboratory was 95.

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“…This includes culture‐based methods to detect viral replication, viral protein detection to measure antigenemia, and molecular detection of viral nucleic acid (NA), such as DNA by real‐time PCR. NA detection by real‐time polymerase chain reaction (PCR) is currently the preferred method because molecular methods are typically highly sensitive and specific . It can be used to precisely quantify CMV viral load (VL); hence it could be used to monitor immune status of patients with solid organ transplants (SOT) or hematopoietic stem cell transplants (HSCT) …”

Section: Introductionmentioning

confidence: 99%

Clinical evaluation of Roche COBAS^® AmpliPrep/COBAS^® TaqMan^® CMV test using nonplasma samples

Hildenbrand¹,

Wedekind²,

et al. 2018

Journal of Medical Virology

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Cytomegalovirus (CMV) infection is a leading cause of loss of hearing, vision, and mental retardation in congenitally infected children. It is also associated with complications of organ transplant and opportunistic HIV coinfection. The Roche COBAS AmpliPrep/COBAS TaqMan CMV test is an FDA-approved test that measures CMV DNA viral load in plasma for the diagnosis and management of patients at risk of CMV-associated diseases. Besides plasma, CMV is often found in bronchoalveolar lavage (BAL), cerebrospinal fluid (CSF), and urine. Thus, monitoring of CMV for critical care of patients in these nonplasma samples becomes necessary. The objective of this study was to conduct an analytic and clinical feasibility study of the Roche CMV test in BAL, CSF, and urine. The lower limit of detection, analytic measurement range, assay sensitivity, specificity, and precision were determined. Results of this study showed that the lower limit of detections were 50, 100, and 300 IU/mL for BAL, CSF, or urine, respectively. The analytic measurement ranges were from log 2.48 to log 5.48. The assay specificity was 94.4% for BAL and 100% for CSF and urine. The assay precision was all within the acceptable range. The performance of Roche test was further compared with 2 comparators including the RealTime CMV assay (Abbott Molecular) and a CMV Quantitative Polymerase Chain Reaction test (Vela Diagnostics). There was a general positive correlation between the Roche method and the Abbott or the Vela method. Overall, this study suggests that the Roche CMV test is suitable for the quantification of CMV viral load DNA in the described nonplasma samples.

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Update on the laboratory diagnosis and monitoring of HIV infection

Cited by 11 publications

References 24 publications

Diagnosis of Human Immunodeficiency Virus Infection

Diagnosis of Human Immunodeficiency Virus Infection

Diagnostic performance and usability of the VISITECT CD4 semi-quantitative test for advanced HIV disease screening

Clinical evaluation of Roche COBAS^® AmpliPrep/COBAS^® TaqMan^® CMV test using nonplasma samples

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Update on the laboratory diagnosis and monitoring of HIV infection

Cited by 11 publications

References 24 publications

Diagnosis of Human Immunodeficiency Virus Infection

Diagnosis of Human Immunodeficiency Virus Infection

Diagnostic performance and usability of the VISITECT CD4 semi-quantitative test for advanced HIV disease screening

Clinical evaluation of Roche COBAS® AmpliPrep/COBAS® TaqMan® CMV test using nonplasma samples

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Clinical evaluation of Roche COBAS^® AmpliPrep/COBAS^® TaqMan^® CMV test using nonplasma samples