Feasibility of Rapid Oral Fluid-Based Diagnosisof HIV Infection in Rural India

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Evaluation of Diagnostic Accuracy, Feasibility and Client Preference for Rapid

Oral Fluid-Based Diagnosis of HIV Infection in Rural India

Nitika Pant Pai1, *, Rajnish Joshi 2, Sandeep Dogra, 3, Bharati Taksande, 2,

S.P. Kalantri,2, Madhukar Pai 4, Pratibha Narang, 2, P. Tulsky, 5,

Arthur L. Reingold 6

1 Immunodeficiency Service, Montreal Chest Institute, McGill University Health

Center, Montreal, Canada,

2 Mahatma Gandhi Institute of Medical Sciences, Sevagram, Maharashtra, India, 3

Acharya Shri Chander College of Medical Sciences, Jammu, India,

4 Department of Epidemiology, Biostatistics and Occupational Health, McGill

University, Montreal, Canada, 5

Department of Internal Medicine, University of California at San

Francisco, San Francisco, California, United States of America, 6 Division of

Epidemiology, University of California at Berkeley, Berkeley, California, United

States of America

Background

Oral fluid-based rapid tests are promising for improving HIV diagnosis and

screening. However, recent reports from the United States of false-positive

results with the oral OraQuick® ADVANCE HIV1/2 test have raised concerns about

their performance in routine practice. We report a field evaluation of the

diagnostic accuracy, client preference, and feasibility for the oral fluid-based

OraQuick® Rapid HIV1/2 test in a rural hospital in India.

Methodology/Principal Findings

A cross-sectional, hospital-based study was conducted in 450 consenting

participants with suspected HIV infection in rural India. The objectives were to

evaluate performance, client preference and

feasibility of the OraQuick® Rapid HIV-1/2 tests. Two Oraquick®

Rapid HIV1/2 tests (oral fluid and finger stick) were administered in

parallel with confirmatory ELISA/Western Blot (reference standard).

Pre- and post-test counseling and face to face interviews were

conducted to determine client preference. Of the 450 participants, 146

were deemed to be HIV sero-positive using the reference standard

(seropositivity rate of 32% (95% confidence interval [CI] 28%, 37%)).

The OraQuick test on oral fluid specimens had better performance with a

sensitivity of 100% (95% CI 98, 100) and a specificity of 100% (95% CI 99, 100),

as compared to the OraQuick test on finger stick specimens with a sensitivity of

100% (95% CI 98, 100), and a specificity of 99.7% (95% CI 98.4, 99.9).

The OraQuick oral fluid-based test was preferred by 87% of the participants for

first time testing and 60% of the participants for repeat testing.

Conclusion/Significance

In a rural Indian hospital setting, the OraQuick® Rapid- HIV1/2 test was found

to be highly accurate. The oral fluid-based test performed

marginally better than the finger stick test. The oral OraQuick test

was highly preferred by participants. In the context of global efforts

to scale-up HIV testing, our data suggest that oral fluid-based rapid

HIV testing may work well in rural, resource-limited settings.

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_______________________

Dr.Nabeel.M.K.

Alliance for Social Health Action (ASHA)

Academy of Medical Sciences,

Kannur Kerala

e-mail: <nabeelmk@...>