Screening Yield of HIV Antigen/Antibody Combination and Pooled HIV RNA Testing for Acute HIV Infection in a High-Prevalence Population

Peters, Philip J.; Westheimer, Emily; Cohen, Stéphanie; Hightow-Weidman, Lisa; Moss, Nicholas J.; Tsoi, Benjamin; Hall, Laura; Fann, Charles; Daskalakis, Demetre; Beagle, Steve; Patel, Pragna; Radix, Asa; Foust, Evelyn; Kohn, Robert; Marmorino, Jenni; Pandori, Mark; Fu, Jie; Samandari, Taraz

doi:10.1001/jama.2016.0286

Cited by 50 publications

(35 citation statements)

References 22 publications

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“…Our study replicated the findings of Peters et al, which determined that rapid third generation HIV tests (i.e., antibody only) detected only 87% of new HIV diagnoses in MSM in New York, California and North Carolina. 15 Additional research is needed to further reduce the window period of rapid HIV tests to identify those with an acute infection. Until then, established testing protocols and implementation of routine HIV RNA testing should be expanded.…”

Section: Discussionmentioning

confidence: 99%

“…3-5,15 In North Carolina, the only state where all publicly funded HIV tests are screened for acute HIV infection through pooled HIV RNA testing, Kuruc et al found that MSM made up a majority of those with acute HIV infection (n=236 acute HIV infections). 5 However, their study did not investigate the specific risk behaviors that distinguished those with acutely diagnosed and new, non-acute diagnosed infections.…”

Section: Introductionmentioning

confidence: 99%

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Differences in Risk Behavior and Demographic Factors Between Men Who Have Sex With Men With Acute and Nonacute Human Immunodeficiency Virus Infection in a Community-Based Testing Program in Los Angeles

Davey

Beymer

Roberts

et al. 2017

JAIDS Journal of Acquired Immune Deficiency Syndromes

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Introduction High viremia combined with HIV-infection status unawareness and increased sexual risk behavior contributes to a disproportionate amount of new HIV infections. Methods From August 2011-July 2015, the Los Angeles LGBT Center conducted 66,546 HIV tests. We compared factors including the presence of concomitant sexually transmitted infections, number of recent sex partners and reported condomless anal intercourse between men who have sex with men (MSM) diagnosed with an acute HIV infection and a non-acute HIV infection using multivariable logistic regression. Results Of 1,082 unique MSM who tested HIV-infected for the first time, 165 (15%) had an acute infection and 917 had a non-acute infection. HIV rapid antibody testing was 84.8% sensitive for detecting HIV infection (95% CI=82.9%-87.1%). Median HIV viral load among acutely infected MSM was 842,000 copies/ml (interquartile range=98,200-4,897,318). MSM with acute infection had twice the number of sex partners in the prior 30-days (median=2), and prior 3-months (median=4) before diagnosis compared to those diagnosed with non-acute infection (p=<0.0001). The odds of acute HIV infection were increased with the numbers of recent sex partners after controlling for age and race/ethnicity (aOR >5 partners in past 30-days=2.74; 95%CI=1.46-5.14; aOR >10 partners in past 3-months=2.41; 95%CI=1.36-4.25). Non-African American MSM had almost double the odds of being diagnosed with an acute HIV infection compared with African-American MSM (aOR=1.97; 95% CI=1.10-3.52). Conclusion MSM with acute HIV infection had nearly twice as many sex partners in the past 30-days and 3-months compared with MSM with newly diagnosed non-acute HIV infection. Those diagnosed with acute HIV infection had decreased odds of being African American MSM.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Differences in Risk Behavior and Demographic Factors Between Men Who Have Sex With Men With Acute and Nonacute Human Immunodeficiency Virus Infection in a Community-Based Testing Program in Los Angeles

Davey

Beymer

Roberts

et al. 2017

JAIDS Journal of Acquired Immune Deficiency Syndromes

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“…AR-reactive tests were repeated for confirmation before results were reported, and the repeat testing was included in turn-around-time calculations. Primary analyses compared the ZSFG results obtained using the new testing algorithm (AR-MS-VL: September – November, 2015) with 1) the ZSFG results obtained using the prior algorithm (RT-IF: January – August, 2015) and 2) results obtained with the new algorithm (AR-MS-VL) from the CDC STOP Study at San Francisco Department of Public Health (SFDPH) targeted testing sites for men who have sex with men (MSM) (2010-2013) [14, 15]. For the purpose of this second comparison, we excluded previous positive individuals from the ZSFG data in order to be consistent with the STOP Study population, where individuals known to be HIV-positive were excluded from the study.…”

Section: Methodsmentioning

confidence: 99%

“…Screening tests were performed on batched specimens every two hours under both algorithms, with STAT testing available only for specimens from labor and delivery. A similar AR-MS-VL algorithm was used and results reported by the Screening Targeted Populations to Interrupt On-Going Chains of HIV Transmission with Enhanced Partner Notification (STOP) Study at HIV testing venues in New York City, New York, North Carolina, and San Francisco, California [14, 15]. …”

Section: Introductionmentioning

confidence: 99%

Real-world performance of the new US HIV testing algorithm in medical settings

Marson

Marlin

Pham

et al. 2017

Journal of Clinical Virology

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Background Our medical center laboratory recently adapted its 24/7, two-hourly testing program to use an ARCHITECT-Multispot-viral load (AR-MS-VL) algorithm in place of a previous rapid test-immunofluorescence (RT-IF) algorithm. Objectives We evaluated screening test performance, acute case detection, turnaround time and ability to resolve HIV status under the new algorithm. Study Design We considered consecutive HIV tests from January-November 2015. AR-MS-VL results at Zuckerberg San Francisco General Hospital and Trauma Center (ZSFG) were compared with RT-IF results at ZSFG and also with AR-MS-VL results in the recently completed CDC Screening Targeted Populations to Interrupt On-going Chains of HIV Transmission with Enhanced Partner Notification (STOP) Study for targeted testing of MSM at publicly funded testing sites in San Francisco. Results Among 21,985 HIV tests performed at ZSFG, 16,467 were tested by RT-IF and 5,518 by AR-MS-VL. There were 321 HIV infections detected, of which 274 (84%) were known HIV+ cases, and 47 were newly identified HIV infections (prevalence 0.22%). Under the AR-MS-VL algorithm, turnaround times for screening and full algorithm results were 3 and 21 hours; status-unresolved cases were reduced (from 47% to 22%) compared with the RT-IF algorithm. The positive predictive value (PPV) of a new-positive AR screening test was low (0.44) at ZSFG, where no acute infections were detected. At STOP Study sites where acute infection was more common, the AR PPV was higher (0.93). All 24 false-positive AR screening tests at ZSFG had a signal/cutoff (S/CO) ratio of <15 and all 88 true-positive tests had S/CO ratio >15. Of 62 acute infections in the STOP Study, 23 (37%) had an S/CO<15. Discussion An AR-MS-VL algorithm is feasible and can return rapid results in a large medical center. In this setting, reactive 4th generation assay tests that are negative for HIV antibodies are typically false-positive with low S/CO ratios.

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“…Cross-sectional studies (even with large sample sizes) may face difficulty recruiting sufficient numbers of patients with acute HIV infection to evaluate the performance of fourth generation rapid tests (such as Determine HIV Combo) during AHI [28]. However, a recent study from the US was able to overcome this challenge in identifying acute infections by implementing a more sensitive test algorithm; in this study the Architect Ag/Ab fourth generation assay was used in addition to pooled RNA testing to identify acute infections [29]. …”

Section: The Alere Hiv Combo Test: a Summary Of Evaluationsmentioning

confidence: 99%

Improving the Quality of Diagnostic Studies Evaluating Point of Care Tests for Acute HIV Infections: Problems and Recommendations

Smallwood

Pai

2017

Diagnostics

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The diagnosis of acute human immunodeficiency virus (HIV) infection (AHI) plays a unique role in preventing the spread of HIV and ending the epidemic. Acutely infected individuals are thought to contribute substantially to forward transmissions of HIV; however, diagnosing AHI in resource-limited settings has proven to be a challenge. While fourth generation antigen-antibody combination assays have been successful in high-resource settings, rapid point of care (POC) versions of these assays have yet to demonstrate high sensitivity to detect AHI. Newer RNA/DNA based POC technologies are being validated, but the challenge to understand the additional value of these devices depends on the quality of study evaluations, in particular choice of study designs and case mix of included populations. In this commentary, we aimed to review the quality of studies evaluating a new fourth generation rapid test for detecting AHI, to identify general methodological limitations and biases in diagnostic accuracy studies, and to recommend strategies for avoiding them in future evaluations. The new studies that were evaluated continued to report the same weaknesses and biases that were seen in previous evaluations of fourth generation rapid tests. We recommend that investigators design future studies carefully, keeping in mind how diagnostic performance may be influenced by prevalence, population, patient case mixes, and reference standards. Care must be taken to avoid biases specific to diagnostic accuracy studies (spectrum, verification, incorporation and reference standard biases). To improve on quality, reporting checklists and guidelines such as Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) and Standards for Reporting Diagnostic accuracy studies (STARD) should be reviewed prior to conducting studies.

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Screening Yield of HIV Antigen/Antibody Combination and Pooled HIV RNA Testing for Acute HIV Infection in a High-Prevalence Population

Cited by 50 publications

References 22 publications

Differences in Risk Behavior and Demographic Factors Between Men Who Have Sex With Men With Acute and Nonacute Human Immunodeficiency Virus Infection in a Community-Based Testing Program in Los Angeles

Differences in Risk Behavior and Demographic Factors Between Men Who Have Sex With Men With Acute and Nonacute Human Immunodeficiency Virus Infection in a Community-Based Testing Program in Los Angeles

Real-world performance of the new US HIV testing algorithm in medical settings

Improving the Quality of Diagnostic Studies Evaluating Point of Care Tests for Acute HIV Infections: Problems and Recommendations

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