Impact of international laboratory partnerships on the performance of HIV/sexually transmitted infection testing in five resource-constrained countries

Abstract

Objective To review a quality control and quality assurance (QC/QA) model established to ensure the validity and reliability of collection, storage, and analysis of biological outcome data, and to promote good laboratory practices and sustained operational improvements in international clinical laboratories. Methods A two-arm randomized community-level HIV behavioral intervention trial was conducted in five countries: China, India, Peru, Russia, and Zimbabwe. The trial was based on diffusion theory utilizing a Community Popular Opinion Leaders (C-POL) intervention model with behavioral and biological outcomes. The model was established by the Biological Outcome Workgroup (BOWG), which collaborated with the Data Coordinating Center (DCC) and John Hopkins University Reference Laboratory. Five international laboratories conducted Chlamydia/gonorrhea PCR, HSV2 EIA, Syphilis RPR/TPPA, HIV EIA/Western Blot, and trichomonas culture. Data were collected at baseline, 12, and 24 months. Results Laboratory performance and infrastructure improved throughout the trial. Recommendations for improvement were consistently followed. Conclusions Quality laboratories in resource-poor settings can be established, operating standards can be improved, and certification can be obtained with consistent training, monitoring, and technical support. Building collaborative partnership relations can establish a sustainable network for clinical trials, and can lead to accreditation and international laboratory development.

Predictors of HIV virological failure and drug resistance in Chinese patients after 48 months of antiretroviral treatment, 2008–2012: a prospective cohort study

“…Plasma HIV RNA was quantified with real-time NASBA (NucliSENS EasyQ, bioMerieux, France) or COBAS (Roche Applied Biosystems, Germany) according to manufacturer’s recommendations using in-house PCR, both of the assays were performed automatically. 19 VF was defined as VL ≥1000 copies/mL. According to WHO protocol, 20 HIVDR tests were performed on samples with VL ≥1000 copies/mL.…”

Chlamydia trachomatisInfection in Pregnancy: The Global Challenge of Preventing Adverse Pregnancy and Infant Outcomes in Sub-Saharan Africa and Asia

“…Large-scale, randomized clinical trials to investigate the true impact and cost-effectiveness of screening and treatment initiatives to improve pregnancy and infant outcomes are urgently needed. Hopefully, the continued evolution of better evidence and increasing availability of C. trachomatis detection assays will eventually persuade policy makers to address this neglected problem of STI screening and treatment in pregnancy [ 197 , 219 – 221 ].…”

Proficiency testing for HIV, tuberculosis and malaria diagnosis in clinical laboratories in Nigeria

“…Nevertheless, just as it has been reported from regional EQAs that public health and reference laboratories in the African region are capable of the accurate determination of disease status, 18,22 so it is believed that the laboratories that participated in this study also can perform satisfactorily if given the necessary support. For example, similar laboratories in Uganda 23 and other resource-constrained countries 24 have been supported in their endeavours to improve the quality of their services and have yielded remarkable improvements. There is, therefore, a need to strengthen laboratory systems in individual countries by providing PT programmes to clinical laboratories, including those that are privately owned with high volumes of work.…”