BioSpace Collaborative

Academic/Biomedical Research
News & Jobs
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

Free Newsletters
My Subscriptions

News by Subject
News by Disease
News by Date
Search News
Post Your News

Job Seeker Login
Most Recent Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Pharm Country
  Bio NC
  Southern Pharm
  BioCanada East
  C2C Services & Suppliers™


Company Profiles

Research Store

Research Events
Post an Event
Real Estate
Business Opportunities

PLoS By Category | Recent PLoS Articles
Anesthesiology and Pain Management - Biochemistry - Biophysics - Biotechnology - Cardiovascular Disorders - Chemical Biology - Chemistry - Computer Science - Critical Care and Emergency Medicine - Dermatology - Diabetes and Endocrinology - Ecology - Evidence-Based Healthcare - Gastroenterology and Hepatology - Geriatrics - Hematology - Immunology - Infectious Diseases - Mathematics - Mental Health - Microbiology - Molecular Biology - Nephrology - Neurological Disorders - Neuroscience - Non-Clinical Medicine - Nutrition - Obstetrics - Oncology - Ophthalmology - Otolaryngology - Pathology - Pediatrics and Child Health - Pharmacology - Physics - Physiology - Public Health and Epidemiology - Radiology and Medical Imaging - Respiratory Medicine - Rheumatology - Science Policy - Surgery - Urology - Virology - Women's Health

Quality Control and Performance of HIV Rapid Tests in a Microbicide Clinical Trial in Rural KwaZulu-Natal
Published: Monday, January 30, 2012
Author: Nina von Knorring et al.

by Nina von Knorring, Mitzy Gafos, Motsei Ramokonupi, Ute Jentsch, the MDP Team


Quality control (QC) and evaluation of HIV rapid test procedures are an important aspect of HIV prevention trials. We describe QC and performance of two rapid tests, Determine™ and Uni-Gold™ used in a microbicide clinical trial in rural KwaZulu-Natal, South Africa.


Internal QC of both HIV rapid tests was conducted at the trial site using a Uni-Gold control kit (Uni-Gold™Recombigen® HIV). Both assays produced the expected results for a total of 4637 QC tests. Study participants were tested for HIV at screening and, if enrolled, at regular time points throughout the study. Positive or discordant results were confirmed by a double HIV immunoassay testing strategy at a local laboratory. Overall, 15292 HIV rapid test were performed. Sensitivity and specificity of Determine was 98.95% (95% CI: 97.72–99.61) and 99.83% (95% CI: 99.70–99.91) respectively [positive predictive value (PPV) 97.91% (95% CI: 96.38–98.92)], for Uni-Gold it was 99.30% (95% CI: 98.21–99.81) and 99.96% (95% CI: 99.88–99.99) respectively [PPV 99.47% (95% CI: 98.46–99.89)].


The results suggest that a Uni-Gold control kit can be used for internal QC of both Uni-Gold and the HIV-1 component of the Determine rapid tests. Both rapid tests performed proficiently in the trial population.