Drug & Device Development

Rapid and point-of-care tests accurately diagnose hepatitis C

Last Updated: 2012-10-15 17:30:13 -0400 (Reuters Health)

By Will Boggs, MD

NEW YORK (Reuters Health) - Point-of-care and rapid diagnostic tests detect hepatitis C very accurately and should be first-line tools for screening, a new paper says.

"These tests offer convenience, accuracy, rapid turnaround time, and the potential to bring about a change in management plan for patients," Dr. Nitika Pant Pai from McGill University, Royal Victoria Hospital, Montreal, Quebec, Canada told Reuters Health. "They are a good tool for patient and population based screening. For now, at risk populations could certainly benefit from them."

These tests might also help meet the Centers for Disease Control and Prevention challenge to test the generation born from 1945 to 1965 for hepatitis C.

Dr. Pai and colleagues reviewed data from 18 studies evaluating how well the globally available rapid diagnostic tests (RDTs) and point of care tests (POCTs) screen for hepatitis C.

According to their report online October 15th in Annals of Internal Medicine, POCTs of blood (serum, plasma, or whole blood) provided sensitivity of 98.9% and specificity of at least 99.5%. Using oral fluid, the POCTs were somewhat less sensitive (97.1%) and specific (98.2%).

RDTs of serum or plasma gave a pooled sensitivity of 98.4% and a pooled specificity of 98.6%.

For both POCT and RDT, the positive likelihood ratios were very high and the negative likelihood ratios were very low.

"Our meta-analysis suggests that POCTs of blood have the highest accuracy, followed by RDTs of serum or plasma and then by POCTs of oral fluid," the researchers conclude. "However, all subgroups showed high positive likelihood ratios, low negative likelihood ratios, and high diagnostic odds ratios."

"For resource limited areas, using point of care tests is a no brainer," Dr. Pai said. "In many settings, first line screening even with conventional tests is not being offered at all, and the tests cost around $10 if done privately. For resource limited settings, the POC tests are typically sold at $1-2 so it offers screening at low price (compared to $10)."

"But again," Dr. Pai pointed out, "it needs people with a vision and political will and commitment to introduce targeted HCV screening to populations at risk."

"Many resource limited areas have dysfunctional health systems and for optimal use of POC we need some more commitment and buy-in from local stakeholders to improve the quality of testing, to set up a reporting system in place for clinicians to act, and to clarify who conducts POC testing and maintain quality of testing failing which these tests could be abused," Dr. Pai said.

SOURCE: http://bit.ly/R1ra62

Ann Intern Med 2012;157:558-566.