BACKGROUND The cobas 4800 BRAF V600 Mutation Test is a CE-marked and FDA-approved in vitro diagnostic assay used to select patients with metastatic melanoma for treatment with the selective BRAF inhibitor vemurafenib. We describe the pre-approval validation of this test in two external laboratories. METHODS Melanoma specimens were tested for BRAF V600 mutations at two laboratories with the: c...

The implementation of antiretroviral therapy demands the need for increased access to viral load (VL) monitoring. Newer real-time VL testing technologies are faster and have larger dynamic ranges and fully automated extraction to benefit higher throughputs in resource-poor environments. The Abbott RealTime human immunodeficiency virus type 1 (HIV-1) assay was evaluated as a new option for testi...

Clostridium difficile infection is a significant health burden, and innovative solutions are needed to shorten time to diagnosis and improve infection control. We evaluated the performance of the cobas® Cdiff test for use on the cobas® Liat® System (cobas® Liat® Cdiff), a single-sample, on-demand, and automated molecular solution with a 20-min turnaround time. The limit of detection was 45-90 c...

Aim—To compare the performance characteristics and clinical application of two diVerent technologies for quantifying serum hepatitis C virus (HCV) RNA levels. Methods—HCV RNA was quantified by Amplicor HCV Monitor assay (Amplicor) and Quantiplex HCV RNA 2.0 assay (bDNA-2) in 119 sera from 107 HCV infected patients. Results—Both assays had similar sensitivity (79.4% for Amplicor; 86.0% for bDNA2...

OBJECTIVE The aim of this study was to evaluate the newly developed ligase chain reaction (LCR) assay for the detection of Chlamydia trachomatis in urogenital specimens using cell culture and Amplicor PCR for comparison. SUBJECTS Two hundred and eighty patients attending hospital or urban STD clinics (high-risk population, 62 men and 84 women) and obstetric/gynaecology clinics (low-risk popul...

AIM To compare the performance characteristics and clinical application of two different technologies for quantifying serum hepatitis C virus (HCV) RNA levels. METHODS HCV RNA was quantified by Amplicor HCV Monitor assay (Amplicor) and Quantiplex HCV RNA 2.0 assay (bDNA-2) in 119 sera from 107 HCV infected patients. RESULTS Both assays had similar sensitivity (79.4% for Amplicor; 86.0% for ...