In vitro diagnostics for screening the blood supply: the new European regulation for IVD and the WHO IVD prequalification programme.

Blood transfusion remains a routine life-saving medical procedure that helps replace blood lost due to surgery, injury or disease. The quality of transfused blood is crucial in this process as blood donors must be free of transfusion-transmissible infections and donated blood should be compatible to that of the recipient. The quality of donated blood could be affected by the quality of in vitro diagnostic medical devices (IVDs) used in the screening process. Consequently, the need for high-quality, safe and well-performing IVDs for use in transfusion medicine arises, accompanied by the need for tight regulations in this domain. In the European Union, the new IVD Regulation will replace the existing IVD Directive within a five-year transitional period. Manufacturers of IVDs are expected to fully comply with the new Regulation by 26 May 2022. In this review, we address the major differences relating to marketing authorization and testing between this new Regulation and its predecessor. We further present the main elements of the prequalification assessment introduced by the WHO for IVDs, including disease-specific IVDs for blood screening laboratories.

Genetic diversity, viraemic and aminotransferases levels in chronic infected hepatitis B patients from Cameroon.

BACKGROUND: HBV infection annually accounts for 1 million deaths worldwide as a result of cirrhosis, liver failure, and hepatocellular carcinoma. In addition to varying responses to antiviral therapy, HBV genotypes have also been shown to be associated with different pattern of disease progression. Despite a high HBV prevalence of >8%, very few studies have been carried out in Cameroon to determine the genotype distribution across the country. The aim of this study was to determine the prevalent genotypes, level of viraemia and correlate these parameters with liver enzymes known to be the most affordable and widely used biomarkers for monitoring disease progression in Cameroon. METHODS: This was a hospital-community based study in which 81 participants who had been previously diagnosed of HBV were recruited and screened for HIV, HCV (for exclusion) and HBsAg for confirmation. Fifty known negative cases for HIV, HBV and HCV were tested and recruited to be used as healthy controls. Viral load and genotyping was performed only for HBV-mono infected cases using the Abbott RealTime HBV automated m2000 system and INNO-LiPA HBV Genotyping assay respectively. Liver enzymes were measured by spectrophotometry on both hepatitis B positive and healthy control cases. RESULTS: The mean alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels were significantly higher (p < 0.001) in HBV infected patients than "healthy controls". Of the 81 HBV infected cases viral load was detected in 76 (93.8%) with mean viral load of 120,807 IU/ml ± 440,159 SD. Mean viral load was significantly different in patients with abnormal AST and ALT when compared with patients who had normal ALT and AST. The identified genotypes in order of prevalence were A (47.4%), E (39.5%), C/E (3.9%) A/C (2.6%), A/E (2.6%), B (1.3%), A/B (1.3%) and B/C (1.3%). CONCLUSION: Genotype E was significantly associated with higher mean viral load and mean AST levels. However, aminotransferase levels may not be a good marker for HBV disease progression as some patients could have normal levels but still present with very high viral loads and therefore, remain active HBV infection with possible high transmission.

Cyclovirus CyCV-VN species distribution is not limited to Vietnam and extends to Africa.

Cycloviruses, small ssDNA viruses of the Circoviridae family, have been identified in the cerebrospinal fluid from symptomatic human patients. One of these species, cyclovirus-Vietnam (CyCV-VN), was shown to be restricted to central and southern Vietnam. Here we report the detection of CyCV-VN species in stool samples from pigs and humans from Africa, far beyond their supposed limited geographic distribution.

Prevalence of metabolic syndrome in human immunodeficiency virus - infected patients from the South-West region of Cameroon, using the adult treatment panel III criteria.

BACKGROUND: Several studies have reported that the metabolic syndrome (MS) is more common in subjects with HIV infection than in HIV-negative individuals. HIV infection and the use of Highly Active Antiretroviral Therapy (HAART) have been shown to predispose HIV-infected persons to MS. In this study, we report the prevalence of MS in Cameroonian HIV-infected subjects receiving different combinations of HAART as well as HIV patients who have never received antiretroviral drugs. METHODS: In this cross-sectional study, 173 treated and untreated HIV-infected out-patients (aged 18-70 years) managed at the Buea and Limbe Regional Hospitals and 50 seronegative individuals (controls) were recruited after obtaining their consent. Ethical approval for this study was obtained from the National Ethics Committee of Cameroon. Metabolic syndrome prevalence was examined using the U.S. National Cholesterol Education Program Adult Treatment Panel III (ATPIII) criteria. Data was analyzed using SPSS® (Statistical Package for the Social Sciences, SPSS Inc., Chicago, IL, USA) version 16. Statistical significance was set at p < 0.05. RESULTS AND DISCUSSION: The prevalence of MS among the HIV patients was 15.6% (27/173) and 8% (4/50) among the controls and the difference was significant (p = 0.022). MS was more prevalent in HIV-infected patients on HAART than in ART-naive patients and seronegative individuals. Overall, the prevalence of MS was significantly higher (p = 0.003) in females (28/153; 18.3%) than in males (3/70; 4.3%). The patients on first-line drugs demonstrated the highest MS prevalence (15/62; 24.2%) followed by the ART-naïve group of patients (7/61; 11.5%) and the lowest prevalence was among the patients on protease inhibitors (5/50; 10%). Patients on the drug combination Lamivudine/Stavudine/Nevirapine had the highest prevalence of MS (50%). CONCLUSIONS: In this study, HAART but not HIV disease plays a significant role in the development of MS. The metabolic complications as a result of treatment with HAART may predispose HIV patients to developing cardiovascular diseases and diabetes, in spite of improvements in morbidity and mortality conferred by immune reconstitution as a result of HAART treatment.