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Accuracy of Rapid and Point-of-Care Screening Tests for Hepatitis C: A Systematic Review and Meta-analysis

Sushmita Shivkumar, MSc; Rosanna Peeling, PhD; Yalda Jafari, MSc; Lawrence Joseph, PhD; and Nitika Pant Pai, MD, MPH, PhD
[+] Article and Author Information

From McGill University and McGill University Health Centre, Montreal, Quebec, Canada, and London School of Hygiene and Tropical Medicine, London, United Kingdom.

Acknowledgment: The authors thank Dr. Gilles Lambert, Dr. Jorge Martinez-Cajas, and Dr. Christiane Claessens for their participation in the discussions related to this Canadian Institutes of Health Research–funded knowledge synthesis project.

Grant Support: By Canadian Institutes of Health Research Knowledge Synthesis Grant 102067, 2010-2012, and by 2010 Canadian Institutes of Health Research New Investigator Award HBF 103210 and a 2011 Grand Challenges Canada Rising Star in Global Health Award (Dr. Pant Pai).

Potential Conflicts of Interest: Dr. Pant Pai: Grant (money to institution): Canadian Institutes of Health Research; Support for travel to meetings for the study or other purposes: Canadian Institutes of Health Research; Grants/grants pending (money to institution): Canadian Institutes of Health Research, Grand Challenges Canada, Bill and Melinda Gates Foundation. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M11-3010.

Requests for Single Reprints: Nitika Pant Pai, MD, MPH, PhD, Division of Clinical Epidemiology, Department of Medicine, McGill University, Royal Victoria Hospital, McGill University Health Centre, 687 Pine Avenue West, V Building, Room V2.19, Montreal, Quebec H3A 1A1, Canada; e-mail, nitika.pai@mcgill.ca.

Current Author Addresses: Ms. Shivkumar and Ms. Jafari: Division of Clinical Epidemiology, Department of Medicine, McGill University Health Centre, V Building, Room V1.04, 687 Pine Avenue West, Montreal, Quebec H3A 1A1, Canada.

Dr. Peeling: London School of Hygiene and Tropical Medicine, Keppel Street, 305b, London WC1E 7HT, United Kingdom.

Dr. Joseph: Department of Epidemiology, Biostatistics, and Occupational Health, Purvis Hall, McGill University, 1020 Pine Avenue West, Montreal, Quebec H3A1A2, Canada.

Dr. Pant Pai: Division of Clinical Epidemiology, Department of Medicine, McGill University, Royal Victoria Hospital, McGill University Health Centre, 687 Pine Avenue West, V Building, Room V2.19, Montreal, Quebec H3A 1A1, Canada.

Author Contributions: Conception and design: S. Shivkumar, R. Peeling, Y. Jafari, N. Pant Pai.

Analysis and interpretation of the data: S. Shivkumar, R. Peeling, L. Joseph, N. Pant Pai.

Drafting of the article: S. Shivkumar, N. Pant Pai.

Critical revision of the article for important intellectual content: R. Peeling, Y. Jafari, L. Joseph, N. Pant Pai.

Final approval of the article: R. Peeling, Y. Jafari, L. Joseph, N. Pant Pai.

Provision of study materials or patients: N. Pant Pai.

Statistical expertise: L. Joseph, N. Pant Pai.

Obtaining of funding: N. Pant Pai.

Administrative, technical, or logistic support: N. Pant Pai.

Collection and assembly of data: S. Shivkumar, Y. Jafari, N. Pant Pai.


Ann Intern Med. 2012;157(8):558-566. doi:10.7326/0003-4819-157-8-201210160-00006
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Background: 170 million persons worldwide are infected with hepatitis C, many of whom are undiagnosed. Although rapid diagnostic tests (RDTs) and point-of-care tests (POCTs) provide a time- and cost-saving alternative to conventional laboratory tests, their global uptake partly depends on their performance.

Purpose: To meta-analyze the diagnostic accuracy of POCTs and RDTs to screen for hepatitis C.

Data Sources: MEDLINE, EMBASE, BIOSIS, and Web of Science (1992 to 2012) and bibliographies of included articles.

Study Selection: All studies evaluating the diagnostic accuracy of POCTs and RDTs for hepatitis C in adults (aged ≥18 years).

Data Extraction: Two independent reviewers extracted data and critiqued study quality.

Data Synthesis: Of 19 studies reviewed, 18 were meta-analyzed and stratified by specimen type (whole blood, serum, plasma, or oral fluid) or test type (POCT or RDT). Sensitivity was similarly high in POCTs of whole blood (98.9% [95% CI, 94.5% to 99.8%]) and serum or plasma (98.9% [CI, 96.8% to 99.6%]), followed by RDTs of serum or plasma (98.4% [CI, 88.9% to 99.8%]) and POCTs of oral fluid (97.1% [CI, 94.7% to 98.4%]). Specificity was also high in POCTs of whole blood (99.5% [CI, 97.5% to 99.9%]) and serum or plasma (99.7% [CI, 99.3% to 99.9%]), followed by RDTs of serum or plasma (98.6% [CI, 94.9% to 99.6%]) and POCTs of oral fluid (98.2% [CI, 92.2% to 99.6%]).

Limitation: Lack of data prevented sensitivity analyses of specific tests.

Conclusion: Data suggest that POCTs of blood (serum, plasma, or whole blood) have the highest accuracy, followed by RDTs of serum or plasma and POCTs of oral fluids. Given their accuracy, convenience, and quick turnaround time, RDTs and POCTs may be useful in expanding first-line screening for hepatitis C.

Primary Funding Source: Canadian Institutes of Health Research.

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