Central Laboratory Structure and Capacity
The UZCHS-CTRC Central Laboratory was established in 1994, and is situated at the Parirenyatwa Group of Hospitals in Harare, within UZ College of Health Sciences’ (UZCHS) Departments of Obstetrics and Gynecology, Medicine, and Pediatrics. The Laboratory Department is comprised of one Central Laboratory at UZCHS, a biosafety level 3 Tuberculosis (TB) laboratory situated at the nearby Wilkins Infectious Disease Hospital, a new cytology laboratory situated in the UZ Department of Obstetrics and Gynecology, and satellite laboratories co-located at each of the six distinct geographic locations of the Clinical Research Sites (CRSs). The Central Laboratory receives a daily average of 350 samples (bloods, urine and swabs) from 120 participants from the CRSs and provides testing in its sections of Chemistry, Serology, Immunology, Molecular, Hematology and Flow Cytometry. Our specimen repository contains a liquid nitrogen plant and is capable of storing up to 20 -80oC and five -20oC freezers.
The UZCHS-CTRC Central Laboratory is a centralized, highly sophisticated, multi-disciplinary research laboratory providing support for NIAID Division of AIDS (DAIDS) funded network protocols, and for research funded by private non-profit and for-profit partners investigating HIV and other related co-morbidities. In the past six years, the laboratory has successfully supported scientific testing for over 30 protocols. The laboratory is staffed by 15 medical scientists and three technicians with experience ranging from five to 15 years.
Good Clinical Lab Practice (GCLP), Accreditation, and Test Validity
The Central Laboratory is certified by the Division of AIDS (DAIDS) as a full reference laboratory and is also ISO 15189 accredited. The laboratory participates in proficiency testing provided by College of American Pathologists (CAP), Virology Quality Assurance (VQA) and United Kingdom National Quality Assurance System (UKNEQAS) 2-3 times per year. Compliance to Good Clinical Laboratory Practice (GCLP) and ISO 15189 is monitored once annually by DAIDS-appointed auditors and South African National Accreditation System (SANAS), respectively.
Increased Testing Capacity Development
Tuberculosis: The UZCHS-CTRC TB Laboratory, located at Wilkins Infections Disease Hospital, is a BSL3 laboratory. It has the capacity to perform sputum smear microscopy, sputum solid and liquid culture and molecular techniques including GeneXpert MTB/RIF to diagnose TB and to detect drug resistant TB in one test. The laboratory is equipped to support local and international clinical trials for diagnosis and treatment of tuberculosis, to support clinical trials on new TB drug development, including pharmacokinetic studies, and to support research on multi-drug resistant (MDR) TB and extensively drug resistant (XDR) TB.
Histology and Cytology: The cytology laboratory processes more than 20 pap smears per day as a standard of care for study participants. Additionally, specialized histology laboratory is currently in development, with a tissue processor and wax embedding center having been procured. We anticipate the laboratory will be ready to start testing during the second quarter of 2014.
Human Papillomavirus (HPV): With assistance from the Infectious Disease Division at UCSF, the Central Laboratory is developing the HPV Southern Dot Blot Hybridization testing method capable of typing more than 30 HPV types, including 14 high risk types. The method will be ready to test protocol samples in the first quarter of 2014.
Vaginal Immune Cells Assessments: The Central Laboratory has increased the range of Flow Cytometry test assays for quantification of immune cells and HIV- tropic cell receptors in the lower female genital tract to assess risk of HIV infection. The process involves isolation of vaginal immune cells from cervical cytobrush and quantification of surface markers by multi parameter Flow Cytometry.
For inquiries to the UZCHS-CTRC Central Laboratory and the services it provides, please contact Laboratory Manager, Allen Matubu.