Low and Decreasing Prevalence and Rate of False Positive HIV Diagnosis — Chókwè District, Mozambique, 2014–2017

Shodell, Daniel; Nelson, Robert; MacKellar, Duncan; Thompson, Ricardo; Casavant, Isabelle; Mugabe, Didier; Pals, Sherri; Ujamaa, Dawud; Bonzela, Juvêncio; Cardoso, Judite; Machava, Salvador; Lourenço, C.; Yang, Chunfu; Parekh, Bharat; Pathmanathan, Ishani; Auld, Andrew F.; Tamele, Stelio; Ouane, Manuel Antonio; Macome, Vania; Chicuecue, Noela; Amane, Guita; Kohatsu, Luciana; Honwana, Nely; Wei, Stanley C.; Kerndt, Peter R.; Monterroso, Edgar; Vergara, Alfredo

doi:10.15585/mmwr.mm6749a3

Cited by 3 publications

(1 citation statement)

References 4 publications

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“…Rapid diagnostic tests (RDTs), also commonly referred to as rapid test kits (RTKs), for HIV diagnosis are vital to public health programs that commonly rely on multi-product algorithms, where a patient is tested with different products brands for confirmation [1][2][3][4][5]. Diagnostic accuracy is critical to ensure the resources for treatment are appropriately applied to all patients in need, thus emphasizing the importance for overall quality assurance of country programs [6] and for implementing improvements in existing programs [7].…”

Section: Introductionmentioning

confidence: 99%

Development of an approach to monitor the manufacturing consistency of HIV rapid diagnostic tests: Panel qualification and potential impact on country programs

2023

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Although regulatory bodies have standards that manufacturers of rapid diagnostic tests (RDTs) must meet for market approval, RDTs have no specific sampling and testing standards to monitor ongoing lot production, unlike pharmaceuticals and certain devices. With the importance of accurate diagnosis for improved health outcomes, independent quality assurance testing is key to ensuring the availability of high-quality RDTs, particularly in low-resource settings. This work develops an approach for HIV RDT lot testing, involving qualification of specimens to enable testing across various RDTs (namely Determine HIV-1/2, OraQuick HIV-1/2, Bioline HIV-1/2 3.0, UniGold HIV, and HIV Ag/Ab Combo). A sampling plan and acceptance criteria were developed per lot (approximating sensitivity and specificity) based on ISO 2859–1: 1999, using the test line response to a qualified panel (disease-positive and negative specimens) as the attribute. Based on general performance of HIV RDTs, an average % defective tests allowed per lot (acceptance quality limit) of 0.65% within ISO 2859–1: 1999 was selected, where RDTs are tested with 80 positives (accept 1 / reject 2 defective results) and 80 negatives (accept 1 / reject 2 defective results) per lot. Panel qualification was conducted with 83 positive and 84 negative serum specimens to select specimens that consistently provided expected results when tested in quadruplicate with three lots per product. While all products yielded consistent results with at least 80 negative specimens, only 4 products did the same for positive specimens. With this approach, each of these 4 RDT products can be tested with the qualified 80-positive specimen panel, requiring the other product to be tested with 20 specimens in quadruplicate. Additionally, this approach was adapted to evaluate HIV antibody/antigen combination tests with Ag panel qualification using p24 samples. While panels were qualified to monitor ongoing lot consistency of HIV RDTs, this approach could be mimicked with other types of diagnostics for monitoring manufacturing consistency, field investigation, small-scale stability checks, and proficiency testing.

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Section: Introductionmentioning

confidence: 99%

Development of an approach to monitor the manufacturing consistency of HIV rapid diagnostic tests: Panel qualification and potential impact on country programs

2023

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High Coverage of Antiretroviral Treatment With Annual Home-Based HIV Testing, Follow-up Linkage Services, and Implementation of Test and Start: Findings From the Chókwè Health Demographic Surveillance System, Mozambique, 2014–2019

Pathmanathan

Nelson

Louvado³

et al. 2021

JAIDS Journal of Acquired Immune Deficiency Syndromes

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Background: Early antiretroviral therapy (ART) is necessary for HIV epidemic control and depends on early diagnosis and successful linkage to care. Since 2014, annual household-based HIV testing and counseling and linkage services have been provided through the Chókwè Health and Demographic Surveillance System for residents testing HIV positive in this high HIV-burden district. Methods: District-wide Test and Start [T&S, ART for all people living with HIV (PLHIV)] began in August 2016, supported by systematic interventions to improve linkage to care and treatment. Annual rounds (R) of random household surveys were conducted to assess trends in population prevalence of ART use and viral load suppression (<1000 viral RNA copies/mL). Results: Between R1 (April 2014–April 2015) and R5 (April 2018–Mar 2019), 46,090 (67.2%) of 68,620 residents aged 15–59 years were tested for HIV at home at least once, and 3711 were newly diagnosed with HIV and provided linkage services. Population prevalence of current ART use among PLHIV increased from 65.0% to 87.5% between R1 and R5. ART population prevalence was lowest among men aged 25–34 years (67.8%) and women aged 15–24 (78.0%), and highest among women aged 35–44 years (93.6%) and 45–59 years (93.7%) in R5. Viral load suppression prevalence increased among all PLHIV aged 15–59 years from 52.0% in R1 to 78.3% in R5. Discussion: Between 2014 and 2019, Chókwè Health and Demographic Surveillance System residents surpassed the UNAIDS targets of ≥81% of PLHIV on ART and ≥73% virally suppressed. This achievement supports the combination of efforts from household-based HIV testing and counseling, support for linkage to care and treatment, and continued investments in T&S implementation.

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Treatment-adjusted prevalence to assess HIV testing programmes

Barr¹,

Lowrance²,

Johnson³

et al. 2021

Bull World Health Organ

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Low and Decreasing Prevalence and Rate of False Positive HIV Diagnosis — Chókwè District, Mozambique, 2014–2017

Cited by 3 publications

References 4 publications

Development of an approach to monitor the manufacturing consistency of HIV rapid diagnostic tests: Panel qualification and potential impact on country programs

Development of an approach to monitor the manufacturing consistency of HIV rapid diagnostic tests: Panel qualification and potential impact on country programs

High Coverage of Antiretroviral Treatment With Annual Home-Based HIV Testing, Follow-up Linkage Services, and Implementation of Test and Start: Findings From the Chókwè Health Demographic Surveillance System, Mozambique, 2014–2019

Treatment-adjusted prevalence to assess HIV testing programmes

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