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. 2017 Jun:91:73-78.
doi: 10.1016/j.jcv.2017.04.003. Epub 2017 Apr 7.

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

Kara G Marson  1 , Robert Marlin  2 , Phong Pham  3 , Stephanie E Cohen  4 , Diane Jones  5 , Marguerite Roemer  3 , Philip J Peters  6 , Barbara Haller  3 , Christopher D Pilcher  5
Affiliations

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

Kara G Marson et al. J Clin Virol. 2017 Jun.

Abstract

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 to 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 5518 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. Considering only patients of HIV-negative or -unknown status, prevalence was 0.22%. Under the AR-MS-VL algorithm, turnaround times for screening results and full algorithm results were 3 and 21h; 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 HIV prevalence was higher and 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.

Keywords: 4th-generation; ARCHITECT; Assay evaluation; Diagnostics; HIV.

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Figures

Figure 1
Figure 1. Panel A. AR-MS-VL1 Flow at Zuckerberg San Francisco General Hospital (ZSFG), Sept – Nov, 2015
1ARCHITECT® HIV Ag/AB Combo (AR) for screening, followed by Multispot HIV-1/HIV-2 Rapid Test (MS) confirmation, and Abbott RealTime HIV-1 assay (VL) as needed for resolution of discrepant results Panel B. AR-MS-VL1 Flow at STOP Study2, 2010-2013 1ARCHITECT® HIV Ag/AB Combo (AR) for screening, followed by Multispot HIV-1/HIV-2 Rapid Test (MS) confirmation, and Abbott RealTime HIV-1 assay (VL) as needed for resolution of discrepant results 2CDC Screening Targeted Populations to Interrupt On-going Chains of HIV Transmission with Enhanced Partner Notification (STOP) Study for targeted testing of MSM; data from publicly funded testing sites in San Francisco
Figure 1
Figure 1. Panel A. AR-MS-VL1 Flow at Zuckerberg San Francisco General Hospital (ZSFG), Sept – Nov, 2015
1ARCHITECT® HIV Ag/AB Combo (AR) for screening, followed by Multispot HIV-1/HIV-2 Rapid Test (MS) confirmation, and Abbott RealTime HIV-1 assay (VL) as needed for resolution of discrepant results Panel B. AR-MS-VL1 Flow at STOP Study2, 2010-2013 1ARCHITECT® HIV Ag/AB Combo (AR) for screening, followed by Multispot HIV-1/HIV-2 Rapid Test (MS) confirmation, and Abbott RealTime HIV-1 assay (VL) as needed for resolution of discrepant results 2CDC Screening Targeted Populations to Interrupt On-going Chains of HIV Transmission with Enhanced Partner Notification (STOP) Study for targeted testing of MSM; data from publicly funded testing sites in San Francisco
Figure 2
Figure 2. Distribution of signal cut-off ratios for specimens reactive on ARCHITECT screening assay at Zuckerberg San Francisco General (ZSFG) (Sept-Nov, 2015) and at the STOP Study1 (2010-2013)
Distribution of signal cut-off ratio values are shown for specimens classified as false-positive or true-positive HIV infections, based on completion of the full AR-MS-VL testing algorithm. The dotted horizontal line illustrates the S/CO ratio of 15 previously suggested [16] as an upper bound on the distribution of false-positive, AR reactive results. There were no acute infections(Multispot indeterminate or Multispot nonreactive specimens that were VL positive) in the ZSFG testing population. 1CDC Screening Targeted Populations to Interrupt On-going Chains of HIV Transmission with Enhanced Partner Notification (STOP) Study for targeted testing of MSM; data from publicly funded testing sites in San Francisco
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