Cryptococcal antigen screening by lay cadres using a rapid test at the point of care: A feasibility study in rural Lesotho

Abstract

IntroductionCryptococcal meningitis is one of the leading causes of death among people with HIV in Africa, primarily due to delayed presentation, poor availability and high cost of treatment. Routine cryptococcal antigen (CrAg) screening of patients with a CD4 count less than 100 cells/mm3, followed by pre-emptive therapy if positive, might reduce mortality in high prevalence settings. Using the cryptococcal antigen (CrAg) lateral flow assay (LFA), screening is possible at the point of care (POC). However, critical shortages of health staff may limit adoption. This study investigates the feasibility of lay counsellors conducting CrAg LFA screening in rural primary care clinics in Lesotho.MethodsFrom May 2014 to June 2015, individuals who tested positive for HIV were tested for CD4 count and those with CD4 <100 cells/mm3 were screened with CrAg LFA. All tests were performed by lay counsellors. CrAg-positive asymptomatic patients received fluconazole, while symptomatic patients were referred to hospital. Lay counsellors were trained and supervised by a laboratory technician and counsellor activity supervisor. Additionally, nurses and doctors were trained on CrAg screening and appropriate treatment.ResultsDuring the study period, 1,388 people were newly diagnosed with HIV, of whom 129 (9%) presented with a CD4 count <100 cells/mm3. Of these, 128 (99%) were screened with CrAg LFA and 14/128 (11%) tested positive. Twelve of the 14 (86%) were asymptomatic, and received outpatient fluconazole. All commenced ART with a median time to initiation of 15.5 days [IQR: 14–22]. Of the asymptomatic patients, nine (75%) remained asymptomatic after a median time of 5 months [IQR; 3–6] of follow up. One (8%) became co-infected with tuberculosis and died and two were transferred out. The two patients with symptomatic cryptococcal meningitis (CM) were referred to hospital, where they later died.ConclusionsCrAg LFA screening by lay counsellors followed by pre-emptive fluconazole treatment for asymptomatic cases, or referral to hospital for symptomatic cases, proved feasible. However, regular follow-up to ensure proper management of cryptococcal disease was needed. These early results support the wider use of CrAg LFA screening in remote primary care settings where upper cadres of healthcare staff may be in short supply.

CD4 Cell Count Threshold for Cryptococcal Antigen Screening of HIV-Infected Individuals: A Systematic Review and Meta-analysis

“…Nineteen studies reported outcomes among 353 CrAg-positive, asymptomatic PLHIV who were started on fluconazole prophylaxis [ 9 , 11 , 19 , 21 , 24–27 , 31 , 38 , 42 , 52 , 54 , 55 , 60–62 , 64 , 70 ], with clinical outcomes from one study [ 19 ] reported in a separate report [ 71 ]. Median follow-up time was 9 months (interquartile range, 6–12 months).…”

High Proportions of Patients With Advanced HIV Are Antiretroviral Therapy Experienced: Hospitalization Outcomes From 2 Sub-Saharan African Sites

“…MSF-supported hospitals usually have relatively high-quality care, consistent funding and resources, and patients with better access to services and ART. The fact that these results were seen even in MSF’s facilities implies that addressing advanced HIV will demand more: improved identification of treatment failure and symptomatic HIV patients in primary healthcare facilities and in the community, better point-of-care diagnostic technology (eg, TB-LAM and CrAg tests for opportunistic infections, or oral HIV self-tests), and patient tracing and psychosocial support for people who drop out of care or stop treatment [ 21 ]. The need remains for expanded access to routine VL testing to verify patients’ adherence and treatment efficacy, and for CD4 as an indicator of immunocompromise to better target opportunistic infection testing.…”

Brief Report: Point of Care Cryptococcal Antigen Screening: Pipetting Finger-Prick Blood Improves Performance of Immunomycologics Lateral Flow Assay

“…No studies to date have assessed the accuracy of the IMMY CrAg LFA for screening patients using a pipette to transfer finger-prick blood. However, in Lesotho, POC CrAg screening (without a laboratory-based reference standard) using a pipette identified 14/129 (11%) CrAg-positive patients with a CD4 count <100 cells/mm 3 , 12 of whom were asymptomatic at the time of testing(16).…”