Diagnostic performance and usability of the VISITECT CD4 semi-quantitative test for advanced HIV disease screening

Ndlovu, Zibusiso; Massaquoi, Lamin; Bangwen, Eugene; Batumba, John N; Bora, Rachelle U; Mbuaya, Joelle; Nzadi, Roger; Ntabugi, Nadine; Kisaka, Patrick; Manciya, Gisele; Moudashirou, Ramzia; Pangani, Harry; Mangochi, Patrick; Makoko, Roberta; Laeken, David Van; Kwitonda, Claude; Ronoh, Yuster; Kuwenyi, Kuziwa; Ortuno, Reinaldo; Mangwanya, Douglas; Zvidzai, Edmore; Mupepe, Tapiwa; Zinyowera, Sekesai; Fajardo, Emmanuel; Ellman, Tom

doi:10.1371/journal.pone.0230453

Cited by 28 publications

(31 citation statements)

References 12 publications

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“…First, integrating our study within an existing community‐based TB‐contact intervention limits its replicability to similar conditions and may overestimate AHD prevalence, due to the high TB burden of the target population (TB index and contacts). Second, the community intervention would have greatly benefited from POC strip tests discriminating above or below 200 CD4 cells/μL on finger‐prick samples [ 80 , 81 ]. This would have allowed for off‐clinic CD4 count testing, enabling a full home‐based POC strategy [ 19 , 32 ].…”

Section: Discussionmentioning

confidence: 99%

Improved detection and management of advanced HIV disease through a community adult TB‐contact tracing intervention with same‐day provision of the WHO‐recommended package of care including ART initiation in a rural district of Mozambique

et al. 2021

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Introduction AIDS‐mortality remains unacceptably high in sub‐Saharan Africa, largely driven by advanced HIV disease (AHD). We nested a study in an existing tuberculosis (TB) contact‐tracing intervention (Xpatial‐TB). The aim was to assess the burden of AHD among high‐risk people living with HIV (PLHIV) identified and to evaluate the provision of the WHO‐recommended package of care to this population. Methods All PLHIV ≥14 years old identified between June and December 2018 in Manhiça District by Xpatial‐TB were offered to participate in the study if ART naïve or had suboptimal ART adherence. Consenting individuals were screened for AHD. Patients with AHD (CD4 < 200 cells/μL or WHO stage 3 or 4) were offered a package of interventions in a single visit, including testing for cryptococcal antigen (CrAg) and TB‐lipoarabinomannan (TB‐LAM), prophylaxis and treatment for opportunistic infections, adherence support or accelerated ART initiation. We collected information on follow‐up visits carried out under routine programmatic conditions for six months. Results A total of 2881 adults were identified in the Xpatial TB‐contact intervention. Overall, 23% (673/2881) were HIV positive, including 351 TB index (64.2%) and 322 TB contacts (13.8%). Overall, 159/673 PLHIV (24%) were ART naïve or had suboptimal ART adherence, of whom 155 (97%, 124 TB index and 31 TB‐contacts) consented to the study and were screened for AHD. Seventy percent of TB index‐patients (87/124) and 16% of TB contacts (5/31) had CD4 < 200 cells/µL. Four (13%) of the TB contacts had TB, giving an overall AHD prevalence among TB contacts of 29% (9/31). Serum‐CrAg was positive in 4.6% (4/87) of TB‐index patients and in zero TB contacts. All ART naïve TB contacts without TB initiated ART within 48 hours of HIV diagnosis. Among TB cases, ART timing was tailored to the presence of TB and cryptococcosis. Six‐month mortality was 21% among TB‐index cases and zero in TB contacts. Conclusions A TB contact‐tracing outreach intervention identified undiagnosed HIV and AHD in TB patients and their contacts, undiagnosed cryptococcosis among TB patients, and resulted in an adequate provision of the WHO‐recommended package of care in this rural Mozambican population. Same‐day and accelerated ART initiation was feasible and safe in this population including among those with AHD.

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Section: Discussionmentioning

confidence: 99%

Improved detection and management of advanced HIV disease through a community adult TB‐contact tracing intervention with same‐day provision of the WHO‐recommended package of care including ART initiation in a rural district of Mozambique

et al. 2021

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“…Moreover, the long turnaround time for CD4 results experienced in the lower health facilities [ 30 ], where >60% of eligible PWH were reported in our study, could be another reason for the low CD4 testing rates among ART-naïve PWH observed in our study. The use of a semiquantitative cheap point-of-care CD4 test (Visitect CD4 lateral flow assay) has been shown to have high diagnostic accuracy and usability in low-resource settings and has the potential to be decentralized across lower health facilities [ 31 ]. Its impact on the frequency of CD4-directed CrAg screening is currently unknown.…”

Section: Discussionmentioning

confidence: 99%

Cryptococcal Antigen Screening Among Antiretroviral Therapy–Experienced People With HIV With Viral Load Nonsuppression in Rural Uganda

Baluku

Mugabe

Mwebaza

et al. 2021

Open Forum Infectious Diseases

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Background World Health Organisation recommends screening for the cryptococcal antigen (CrAg), a predictor of cryptococcal meningitis, among antiretroviral therapy (ART) naïve people living with HIV (PLHIV) with CD4 <100 cells/mm 3. CrAg positivity among ART-experienced PLHIV with viral load (VL) non-suppression is not well established, yet high VLs are associated with cryptococcal meningitis independent of CD4 count. We compared the frequency and positivity yield of CrAg screening among ART-experienced PLHIV with VL non-suppression and ART-naïve PLHIV with CD4 <100 cells/mm 3 attending rural public health facilities in Uganda. Methods We reviewed routinely generated programmatic reports on cryptococcal disease screening from 104 health facilities in eight rural districts of Uganda from January 2018 to July 2019. A lateral flow assay (IMMY CrAg®) was used to screen for cryptococcal disease. PLHIV were eligible for CrAg screening if they were ART-naïve with CD4 <100 cell/mm 3 or ART-experienced with an HIV VL >1,000 copies/ml after at least 6 months of ART. We used Pearson’s chi-square test to compare the frequency and yield of CrAg screening. Results Of 71,860 ART-experienced PLHIV, 7210 (10.0%) were eligible for CrAg screening. Among 15,417 ART-naïve PLHIV, 5,719 (37.1%) had a CD4 count measurement, of whom 937 (16.4%) were eligible for CrAg screening. The frequency of CrAg screening was 11.5% (830/7,210) among eligible ART-experienced PLHIV compared to 95.1% (891/937) of eligible ART- naïve PLHIV (p<0.001). The CrAg positivity yield was 10.5% among eligible ART-experienced PLHIV compared to 13.8% ART-naïve PLHIV (p=0.035). Conclusion The low frequency and high positivity yield of CrAg screening among ART-experienced PLHIV with VL non-suppression suggest a need for VL- directed CrAg screening in this population. Studies are needed to evaluate the cost-effectiveness and impact of CrAg screening and fluconazole prophylaxis on the outcomes of ART – experienced PLHIV with VL non-suppression.

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“…Clear Blue Digital Pregnancy Test was the first FDA approved digitized test to have been launched in the market in 2003 (Etherington, 2020 ). Lateral flow technology is also in use for rapid HIV testing; Visitect CD4 is an example of a rapid disposable LFA test developed for HIV patients, it quantifies CD4 protein in T-cells (Ndlovu et al, 2020 ). Other examples of POCT technologies include - ProFlow, C.Diff Quik Chek & Sickle SCAN.…”

Section: Commonly Employed Poct Technologiesmentioning

confidence: 99%

Microfluidic Point-of-Care Testing: Commercial Landscape and Future Directions

Sachdeva

Davis

Saha

2021

Front. Bioeng. Biotechnol.

181

108

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Point-of-care testing (POCT) allows physicians to detect and diagnose diseases at or near the patient site, faster than conventional lab-based testing. The importance of POCT is considerably amplified in the trying times of the COVID-19 pandemic. Numerous point-of-care tests and diagnostic devices are available in the market including, but not limited to, glucose monitoring, pregnancy and infertility testing, infectious disease testing, cholesterol testing and cardiac markers. Integrating microfluidics in POCT allows fluid manipulation and detection in a singular device with minimal sample requirements. This review presents an overview of two technologies - (a.) Lateral Flow Assay (LFA) and (b.) Nucleic Acid Amplification - upon which a large chunk of microfluidic POCT diagnostics is based, some of their applications, and commercially available products. Apart from this, we also delve into other microfluidic-based diagnostics that currently dominate the in-vitro diagnostic (IVD) market, current testing landscape for COVID-19 and prospects of microfluidics in next generation diagnostics.

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Diagnostic performance and usability of the VISITECT CD4 semi-quantitative test for advanced HIV disease screening

Cited by 28 publications

References 12 publications

Improved detection and management of advanced HIV disease through a community adult TB‐contact tracing intervention with same‐day provision of the WHO‐recommended package of care including ART initiation in a rural district of Mozambique

Improved detection and management of advanced HIV disease through a community adult TB‐contact tracing intervention with same‐day provision of the WHO‐recommended package of care including ART initiation in a rural district of Mozambique

Cryptococcal Antigen Screening Among Antiretroviral Therapy–Experienced People With HIV With Viral Load Nonsuppression in Rural Uganda

Microfluidic Point-of-Care Testing: Commercial Landscape and Future Directions

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