Laboratory testing for the diagnosis of HIV infection : updated recommendations

Branson, Bernard M.; Owen, S. Michele; Wesolowski, Laura G.; Bennett, Berry; Werner, Barbara G.; Wroblewski, Kelly; Pentella, Michael

doi:10.15620/cdc.23447

Cited by 83 publications

(53 citation statements)

References 132 publications

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“…There was no evidence in the medical chart that the remaining two patients were notified of their diagnosis through 2 years of follow-up. The median length of stay for those who did not receive results was 2 days (IQR 1-7) compared to a median length of stay of 10 days (IQR [5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20] for those who did receive their results. Sixty-four percent of patients with new HIV diagnoses linked to care within 90 days of the hospital discharge date.…”

Section: Resultsmentioning

confidence: 99%

“…As laboratories conform to CDC guidelines with uptake of fourth-generation HIV-1/2 Ag/Ab combination immunoassay screening tests and confirmation HIV-1/HIV-2 rapid antibody differentiation immunoassays, we would anticipate a decrease in the turnaround time for confirmation. 20 This may, in turn, minimize the number of patients discharged from the hospital with pending HIV test results.…”

Section: Discussionmentioning

confidence: 99%

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The Perilous Road from HIV Diagnosis in the Hospital to Viral Suppression in the Outpatient Clinic

ColasantiJonathan

GoswamiNeela

KhoubianJonathan

et al. 2016

AIDS Research and Human Retroviruses

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The HIV care continuum has received considerable attention in recent years, however, few care continua focus on the population of patients who are diagnosed during an inpatient hospital admission. We aimed to describe the HIV care continuum for patients newly diagnosed during hospitalization through 24-month follow-up. A retrospective chart review of HIV patients diagnosed at Grady Memorial Hospital from 2011 to 2012 was performed and records were matched to Georgia Department of Public Health HIV/AIDS surveillance data. Descriptive statistics and statistical tests of independence were utilized. Ninety-four new diagnoses were confirmed during the 2-year study period. Median age was 43 years (interquartile range [IQR] 30-51), 77% were male, 72% were non-Hispanic Black, 31% were men who have sex with men (MSM), and 77% were uninsured. Median CD4 count at diagnosis was 134 cells/lL (IQR 30-307). Eighty-four percent received their diagnosis before hospital discharge, 68% linked to care by 90 days, 73% were retained for 12 months, 48% were virologically suppressed by 12 months, 58% were retained for 24 continuous months, and 38% achieved continuous viral suppression (VS) during the initial 24 months after diagnosis. Late diagnosis is a persistent problem in hospitalized patients. Despite relative success with linkage to care and 12-month retention in care, a minority of patients maintained retention and VS for 24 continuous months.

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Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

The Perilous Road from HIV Diagnosis in the Hospital to Viral Suppression in the Outpatient Clinic

ColasantiJonathan

GoswamiNeela

KhoubianJonathan

et al. 2016

AIDS Research and Human Retroviruses

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“…Current HIV-1 quantitative VL assays, including the Veris HIV-1 assay, are not approved for diagnosis of HIV, only for monitoring VL in patients with HIV-1. Testing guidelines (12,13) indicate that HIV-1 RNA is recommended for confirmation of indeterminate or equivocal results from fourthgeneration (HIV antibody and antigen) screening assays in patients suspected of recent infection who have not yet seroconverted. HIV-1 RNA testing is not recommended for broader-use screening for several reasons, including cost and level of false positives.…”

Section: Discussionmentioning

confidence: 99%

European Multicenter Study on Analytical Performance of Veris HIV-1 Assay

Braun¹,

Delgado

Drago

et al. 2017

J Clin Microbiol

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The analytical performance of the Veris HIV-1 assay for use on the new, fully automated Beckman Coulter DxN Veris molecular diagnostics system was evaluated at 10 European virology laboratories. The precision, analytical sensitivity, performance with negative samples, linearity, and performance with HIV-1 groups/subtypes were evaluated. The precision for the 1-ml assay showed a standard deviation (SD) of 0.14 log 10 copies/ml or less and a coefficient of variation (CV) of Յ6.1% for each level tested. The 0.175-ml assay showed an SD of 0.17 log 10 copies/ml or less and a CV of Յ5.2% for each level tested. The analytical sensitivities determined by probit analysis were 19.3 copies/ml for the 1-ml assay and 126 copies/ml for the 0.175-ml assay. The performance with 1,357 negative samples demonstrated 99.2% with not detected results. Linearity using patient samples was shown from 1.54 to 6.93 log 10 copies/ml. The assay performed well, detecting and showing linearity with all HIV-1 genotypes tested. The Veris HIV-1 assay demonstrated analytical performance comparable to that of currently marketed HIV-1 assays. (DxN Veris products are Conformité Européenne [CE]-marked in vitro diagnostic products. The DxN Veris product line has not been submitted to the U.S. FDA and is not available in the U.S. market. The DxN Veris molecular diagnostics system is also known as the Veris MDx molecular diagnostics system and the Veris MDx system.)

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“…However, positive serology with a negative RNA test may either indicate previous HCV clearance or false reactive serology. Acute HIV infection is often diagnosed by using a combination of serology and molecular tests . The best approach to improving the positive predictive value of confirmatory testing is to use an independent sample and a test that is sufficiently dissimilar so that both assays would not be prone to the same cause for false positivity.…”

Section: Confirmation Tests: Independent or Replicating Screening Assmentioning

confidence: 99%

Lessons in diagnostic virology: expected and unexpected sources of error

Zyl

Maritz

Newman

et al. 2019

Reviews in Medical Virology

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Viral diagnostics have shown continued innovation, with serological and molecular diagnostic assays pushing the limits of sensitivity. Technology has provided new automated shared diagnostic platforms that reduce hands-on time, while with globalisation of the diagnostic market, commercial assays are applied across epidemiologically diverse settings on different patient and viral populations. However, with these novel developments, new and often unexpected sources of diagnostic error emerge. In this review we will reflect on case studies that highlight these often underappreciated or unexpected diagnostic errors spanning pre-analytical, analytical, and post-analytic processes. We will also suggest approaches that could help identify error and reduce the impact on patient management.

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Laboratory testing for the diagnosis of HIV infection : updated recommendations

Abstract: , data are insufficient to recommend use of the FDA-approved single-use rapid HIV-1/HIV-2 antigen/antibody combination immunoassay as the initial assay in the algorithm.

Cited by 83 publications

References 132 publications

The Perilous Road from HIV Diagnosis in the Hospital to Viral Suppression in the Outpatient Clinic

The Perilous Road from HIV Diagnosis in the Hospital to Viral Suppression in the Outpatient Clinic

European Multicenter Study on Analytical Performance of Veris HIV-1 Assay

Lessons in diagnostic virology: expected and unexpected sources of error

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