In areas of limited resources, point-of-care diagnostic testing is being increasingly used to identify disease, determine prognosis, and monitor treatment. Investments in new diagnostics are starting to improve care. Health systems need to evolve to reap benefits for global health.

Inadequate levels of immunization against childhood diseases remain a significant public health problem in resource-poor areas of the globe. Nonetheless, the reasons for incomplete vaccination and non-uptake of immunization services are poorly understood. This study aimed at finding out the reasons for non-vaccination and the magnitude of missed opportunities for vaccination in children less than two years of age in a rural area in southern Mozambique.

BACKGROUND: North American and European guidelines for dual‐platform (DP) flow cytometry recommend absolute CD4 T‐cell counts to be calculated from two parameters: the absolute lymphocyte counts obtained on a hematology analyzer and the percentages of CD4+ cells among lymphocytes (CD4%/lympho) obtained by flow cytometry. Nevertheless, the identification of lymphocytes is error‐prone: a poor match between these common denominators in the two systems is the main source of inaccuracy. In contrast, total leucocyte counts (white cell counts [WCC]) and CD4% among the gated CD45+ leucocytes (CD4%/leuco) can be determined with greater accuracy. Methods: We introduced “PanLeucogating,” i.e., we used total leucocytes as the common denominator for improving the precision of DP absolute CD4 counting. Correlations and Bland‐Altman tests were used for statistical analysis. Results: First, 22 stabilized blood product samples were provided by U.K. National External Quality Assessment Scheme (NEQAS) and a higher accuracy and precision of CD4 counts were documented using PanLeucogating compared with lymphocyte gating. Next, 183 fresh and 112 fixed (TransFix) whole blood samples were used to compare DP methods and single‐platform (SP) methodology, including both volumetric and bead‐based techniques. A particularly high correlation and comparable precision of absolute CD4 counts were observed between the SP volumetric method and DP PanLeucogating (R² = 0.990; bias 6 ± SD 17%). The SP volumetric method showed lower levels of agreement with the DP lymphocyte gating (R² = 0.758; bias 14 ± SD 51%) and with the SP bead‐based method (R² = 0.923; bias 4 ±SD 31%). Conclusions: These observations show that DP leucocyte counts (WCC) should replace lymphocyte counts as the “common denominator” although CD4%/lympho values can, as an extra step, be also provided readily if requested. When coupled with quality control for WCC on hematology analyzers, the DP method with CD45 PanLeucogating represents a robust CD4 T‐cell assay that is as accurate as the SP volumetric technique. This DP method uses only two, CD45 and CD4, antibody reagents and can be run on any pair of hematological analyzer plus flow cytometer. Cytometry (Clin. Cytometry) 50:69–77, 2002.

To evaluate the accuracy of point-of-care tests (POCTs) for CD4 cell, clinical chemistry and hemoglobin in primary healthcare clinics in Mozambique. POCT and laboratory-based assays were conducted on adult HIV-positive patients enrolled consecutively at primary healthcare clinics in Mozambique. Patients were tested on-site with POCT CD4 (Pima), clinical chemistry (Reflotron) and hemoglobin (HemoCue) devices using finger prick blood. Results obtained on paired blood samples were used for agreement analysis (bias and limits of agreement). Repeatability analysis was also performed for POCT CD4 cell counting. Primary health nurses operating the Pima, Reflotron and HemoCue POCT devices produced results with low levels of bias for CD4+ T-cell counts (−52.8 cells/μl), alanine aminotransferase (−0.2 U/l), aspartate aminotransferase (−4.0 U/l) and hemoglobin (0.95 g/dl). CD4+ T-cell counts in paired specimens of finger prick and venous blood tested on the POCT CD4 device were in close agreement (bias −9 cells/μl, coefficient of variation 10.6%). The repeatability of POCT CD4 cell counting was similar to that observed with laboratory instruments (bias −6.2 cells/μl, coefficient of variation 10.7% vs. bias −5.7 cells/μl, coefficient of variation 7.5%). Primary health clinic nurses generated accurate results for CD4+ T-cell counts, liver enzymes and hemoglobin using simple POC devices on finger prick samples at decentralized antiretroviral therapy (ART) clinics. POC diagnostics to monitor ART at primary healthcare level is technically feasible and should be utilized in efforts to decentralize HIV care and treatment.

Objective: To evaluate the accuracy of a point-of-care (POC) nucleic acid–based test (NAT) for early infant HIV diagnosis (EID) in primary health clinics in Mozambique. Methods: POC and laboratory NAT EID tests were conducted on matched blood samples collected from 827 HIV-exposed infants younger than 18 months who were enrolled consecutively at 4 periurban primary health clinics and the central hospital in Maputo. Lancet heel draw blood collected by nurses was tested on site for HIV-1/-2 RNA on the Alere HIV NAT POC device and also used to create dried blood spots for later laboratory EID testing on the Roche Cobas Taqman/Ampliprep instrument. Results were used to determine the sensitivity, specificity, and agreement between the POC and laboratory NAT EID tests. Results: The sensitivity and specificity of POC NAT EID testing were 98·5% (95% confidence interval (CI): 91.7 to 99.9, n = 65) and 99·9% (95% CI: 99.3 to 100, n = 762), respectively, compared with laboratory EID tests. Overall agreement was high (Cohen kappa = 0·981; 95% CI: 0.96 to 1.00). Positive (98·5%; 95% CI: 96·3 to 100) and negative 99.9% (95% CI: 99.7 to 100) test agreement was also high. Conclusions: Primary health care nurses accurately performed POC NAT EID testing within primary health care clinics. On-site nucleic acid–based EID testing is technically feasible in clinic settings and could be used in efforts to improve access to pediatric HIV antiretroviral treatment.