Quality control and quality assurance for point of care (POC) diagnostic tests

Quality assurance and quality control

In recent years, quality assurance (QA) and good manufacturing practice (GMP) have become increasingly important in the pharmaceutical industry. They are of particular importance in the manufacture of veterinary vaccines since such products have the following specific characteristics: The active ingredients are almost always produced by the manufacturer (and not as is generally the case by anot...

Quality assurance of rapid diagnostic tests for malaria in routine patient care in rural Tanzania.

Histidine-rich protein II (HRP2)-based malaria rapid diagnostic tests (RDTs) have shown high sensitivity and specificity for detecting Plasmodium falciparum malaria in a variety of study settings. However, RDTs are susceptible to heat and humidity and variation in individual performance, which may affect their use in field settings. We evaluated sensitivity and specificity of RDTs during routin...

Quality assurance for point-of-care testing in Zimbabwe

Zimbabwe was one of the sub-Saharan countries most severely affected by HIV and AIDS. The first AIDS case was reported in 1985. HIV prevalence increased sharply from 1985 to the mid-90s, peaking at 27.7% in 1997; thereafter, it started to decline (Figure 1).1 According to the National AIDS Council, HIV prevalence was estimated to be 15.0% as of the end of 2014.2 Zimbabwe has a population of 15....

Quality assurance for point-of-care testing: Ethiopia’s experience

In 2015, there were an estimated 729 517 people living with HIV in Ethiopia, including 95 094 children (aged 0–14 years), according to the 2015 Estimation and Projection Package/Spectrum modelling. HIV prevalence at the national level is 4.2% among urban populations and 0.6% rural populations; by gender, HIV prevalence is 1.52% among women and 1.0% among men.1 The HIV epidemic in Ethiopia is pr...

Quality assurance for point-of-care diagnostic testing: It is not negotiable