Performance of a new point of care HIV viral load assay
Research type
Research Study
Full title
Correlation between GeneXpert, a novel Human Immunodeficiency Virus type 1(HIV-1) assay for viral load measurement assay with the Abbott m2000 real-time assay.
IRAS ID
162236
Contact name
Kaveh Manavi
Contact email
Sponsor organisation
Cepheid Europe
Duration of Study in the UK
0 years, 1 months, 1 days
Research summary
As the result of combination antiretroviral therapy (cART), HIV infection has become a chronic infection. HIV viral load (VL) measurement is the best method for monitoring success of cART for suppression of HIV replication. Because of a life-long requirement for cART, monitoring of VL should also be measured regularly. On average, three annual VL measurements for HIV patients are recommended. Historically, VL measurements have been carried out in laboratories with a turnaround time of one week on average.
HIV care has been delivered in one of the following models; (i) obtaining blood sample for VL measurement one week prior to patient’s appointment with the clinician, or (ii) obtaining blood sample on the same day of patient’s appointment with their clinician.
The advantage of the first model of delivery is clinicians’ full knowledge of the patient’s recent results at the time of issue of the cART prescription. This model, however, requires patients to attend the clinic on two separate days which can be disruptive for an individual’s lifestyle.
The second model of delivery has the advantage of convenience as patients undergo VL measurement and receive the new supply of cART on the same day. The disadvantage of this model is that the clinician issues cART without knowledge of the patient’s recent VL measurement and this can pose a risk if cART is failing.
A point of care VL assay can provide a third model of delivery; one that provides the most recent VL measurement on the same day of sampling.
The aim of the present study is to investigate the correlation of a new point of care VL assay with the standard laboratory based assays, in Queen Elizabeth Hospital Birmingham. We will invite consecutive patients to participate in the study until 100 adult HIV infected patients have been consented.REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
14/WM/1232
Date of REC Opinion
9 Feb 2015
REC opinion
Further Information Favourable Opinion