Evaluation of the CDC proposed laboratory HIV testing algorithm among men who have sex with men (MSM) from five US metropolitan statistical areas using specimens collected in 2011

Masciotra, Silvina; Smith, Amanda; Youngpairoj, Ae S.; Sprinkle, Patrick; Miles, Isa; Sionéan, Catlainn; Paz–Bailey, Gabriela; Johnson, Jeffrey A.; Owen, S. Michele

doi:10.1016/j.jcv.2013.09.002

Cited by 15 publications

(12 citation statements)

References 29 publications

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“…This test combines a p24 antigen assay with traditional antibody testing, thus reducing the window period, though this point-of-care assay does not perform as well as lab-based fourth generation antigen–antibody combination tests 16,60. A street-based testing program in Spain demonstrated self-testing with this kit to be feasible, with 92% of participants obtaining a valid result 61.…”

Section: Discussionmentioning

confidence: 99%

Arguments for and against HIV self-testing

Wood¹,

Ballenger²,

Stekler³

2014

HIV

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Approximately 60% of human immunodeficiency virus (HIV)-infected individuals are unaware of their infection, and stigma and discrimination continue to threaten acceptance of HIV testing services worldwide. Self-testing for HIV has garnered controversy for years and the debate reignited with the approval of a point-of-care test for over-the-counter sale in the US in 2012. Here, we present arguments for and against HIV self-testing. The case in support of HIV self-testing contends that: the modality is highly acceptable, especially among the most at-risk individuals; self-testing empowers users, thus helping to normalize testing; and mutual partner testing has the potential to increase awareness of risk and avert condomless sex between discordant partners. Arguments against HIV self-testing include: cost limits access to those who need testing most; false-negative results, especially during the window period, may lead to false reassurance and could promote sex between discordant partners at the time of highest infectivity; opportunities for counseling, linkage to care, and diagnosis of other sexually transmitted infections may be missed; and self-testing leads to potential for coercion between partners. Research is needed to better define the risks of self-testing, especially as performance of the assays improves, and to delineate the benefits of programs designed to improve access to self-test kits, because this testing modality has numerous potential advantages and drawbacks.

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Section: Discussionmentioning

confidence: 99%

Arguments for and against HIV self-testing

Wood¹,

Ballenger²,

Stekler³

2014

HIV

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“…The new algorithm suggested using a 4th generation screening assay followed by a rapid antibody test that differentiates HIV-1 and HIV-2 for confirmation of repeatedly reactive specimens. Despite several studies establishing this algorithm to be an effective strategy in adults [11], high-risk individuals and in persons with established HIV-1 infection [20][21][22][23], this is the first study involving a large sample size (6242 specimens from 5808 patients) to evaluate the clinical utility and diagnostic performance of an alternate antibody-based, non-western blot dependent algorithm in both pediatric and obstetric patients. The diagnosis of HIV infection in these patient populations is of paramount importance because: (1) HIV disease typically progresses much more rapidly in children (>18 months) than it does in adults (2) in the United States, the CDC and U.S. Preventive Services Task Force (USPSTF) recommends universal HIV testing in pregnant women to prevent mother-to-child transmission of HIV and to ensure optimal clinical and preventive care [37].…”

Section: Discussionmentioning

confidence: 99%

“…Parallel testing by MS and the VITROS reduced the time to result thus supporting the needs of the labor and delivery populations at TCH. Although multiple studies have evaluated the performance of alternative WB independent diagnostic strategies, and the newly recommended CDC/APHL algorithm for the rapid diagnosis of HIV infections in adults in high risk populations [11,[19][20][21][22][23][24], none of these studies have focused on either pediatric or obstetric patients, two relatively low risk populations in which varying degrees of differences in immune response have been reported compared to the average adult population [25][26][27][28][29][30][31]. Additionally, only a limited number of studies have evaluated the performance of the individual components of this algorithm in these low risk patient populations [32].…”

Section: Introductionmentioning

confidence: 99%

Performance of a parallel diagnostic algorithm for HIV diagnosis in low risk pediatric and obstetric patient populations

Chandramohan

Vargas

Dowlin

et al. 2014

Journal of Clinical Virology

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“…HIV-1 infected MSM were identified through routine testing in five US cities (Baltimore, Denver, Los Angeles, Miami, and Washington DC), as described in detail [28]. Briefly, whole blood in EDTA was collected from individuals with an initial HIV-1 rapid test result or self-reported HIV positives.…”

Section: Methodsmentioning

confidence: 99%

Evaluation of Dried Blood Spots with a Multiplex Assay for Measuring Recent HIV-1 Infection

et al. 2014

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Laboratory-based HIV tests for recent infection (TRIs), which primarily measure a specific serological biomarker(s) that distinguishes recent from long-term HIV infection, have facilitated the estimation of population-based incidence. Dried blood spots (DBS) on filter paper are an attractive sample source for HIV surveillance, given the simplified and cost-effective methods of specimen collection, storage, and shipment. Here, we evaluated the use of DBS in conjunction with an in-house multiplex TRI, the HIV-1-specific Bio-Plex assay, which measures direct antibody binding and avidity to multiple HIV-1 analytes. The assay performance was comparable between matched plasma and DBS samples from HIV-1 infected individuals obtained from diverse sources. The coefficients of variation, comparing the median antibody reactivity for each analyte between plasma and DBS, ranged from 2.78% to 9.40% and the correlation coefficients between the two sample types ranged from 0.89 to 0.97, depending on the analyte. The correlation in antibody reactivity between laboratory and site-prepared DBS for each analyte ranged from 0.87 to 0.98 and from 0.90 to 0.97 between site-prepared DBS and plasma. The correlation in assay measures between plasma and DBS indicate that the sample types can be used interchangeably with the Bio-Plex format, without negatively impacting the misclassification rate of the assay.

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Evaluation of the CDC proposed laboratory HIV testing algorithm among men who have sex with men (MSM) from five US metropolitan statistical areas using specimens collected in 2011

Cited by 15 publications

References 29 publications

Arguments for and against HIV self-testing

Arguments for and against HIV self-testing

Performance of a parallel diagnostic algorithm for HIV diagnosis in low risk pediatric and obstetric patient populations

Evaluation of Dried Blood Spots with a Multiplex Assay for Measuring Recent HIV-1 Infection

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