Article Category:
Research Article

Prescreening with a Rapid Diagnostic Test Followed by a Confirmatory Qualitative Nucleic Acid Test Can Simplify Hepatitis C Diagnosis

Rujipat Wasitthankasem National Biobank of Thailand, National Science and Technology Development Agency, Pathum Thani, Thailand;

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Nawarat Posuwan Chulabhorn International College of Medicine, Thammasat University, Rangsit Campus, Patum Thani, Thailand;

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Napaporn Pimsing Phetchabun Provincial Public Health Office, Phetchabun, Thailand;

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Wijittra Phaengkha Nam Nao Hospital, Nam Nao District, Phetchabun, Thailand;

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Saranya Ngamnimit Phetchabun Provincial Public Health Office, Phetchabun, Thailand;

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Preeyaporn Vichaiwattana Center of Excellence in Clinical Virology, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand

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Ilada Thongpan Center of Excellence in Clinical Virology, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand

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Sissades Tongsima National Biobank of Thailand, National Science and Technology Development Agency, Pathum Thani, Thailand;

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Sompong Vongpunsawad Center of Excellence in Clinical Virology, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand

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Yong Poovorawan Center of Excellence in Clinical Virology, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand

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DOI:
https://doi.org/10.4269/ajtmh.21-1016
Volume/Issue:
Volume 106: Issue 5
Page(s):
1534–1538
Restricted access
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ABSTRACT.

Asymptomatic hepatitis C virus (HCV) infection without treatment is associated with chronic liver diseases including hepatocellular carcinoma. A major obstacle to hepatitis C diagnosis leading to antiviral treatment in some developing countries is the complicated HCV testing required before treatment. To simplify an HCV test-to-treat strategy, which could lead to timely diagnosis and treatment at the point-of-care, we evaluated the performance of four anti-HCV rapid diagnostic tests (RDTs) (Abon, Blue Cross, Healgen, and SD Bioline). They yielded comparable sensitivity (80–83%), specificity (99–100%), and accuracy (90–91.5%). When we field-tested Abon in 4,769 residents of an HCV-endemic province in Thailand, 306 seropositive individuals (6.4%) were identified. In comparison, laboratory test using an automated commercial chemiluminescent microparticle immunoassay (ARCHITECT anti-HCV assay, Abbott Diagnostics, Chicago, IL) identified slightly more seropositives (327/4,769 or 6.9%). Field implementation suggests that Abon was sensitive (88.7%), specific (99.6%), and accurate (98.9%). Furthermore, 82% (250/306) of Abon-positive samples had detectable HCV RNA as determined by nucleic acid test (cobas® 4800 HCV assay; Roche Diagnostics GmbH, Mannheim, Germany). The same 250 samples out of 327 reactive in Abbott immunoassay also had detectable HCV RNA (mean RNA level: log 6.28 IU/mL, range: log 3.06– 7.78 IU/mL). The use of RDT followed by qualitative nucleic acid test can cost-effectively identify the majority of HCV seropositive individuals with active infection, which will obviate the need for expensive viral load quantification tests when simplifying HCV diagnosis for the test-to-treat program at the point-of-care.

Author Notes

Address correspondence to Yong Poovorawan, Center of Excellence in Clinical Virology, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, 1873 Rama Rd., Pathumwan, Bangkok 10330, Thailand. E-mail: yong.p@chula.ac.th

Financial support: This study was supported by the National Research Council, Grant for New Researcher (NRCT5-TRG630014-04) and Thailand Grand Challenges (RES_64_058_30_020). The Center of Excellence in Clinical Virology of Chulalongkorn University and Hospital and the Regional Health Office 2 Fund, Thailand.

Authors’ addresses: Rujipat Wasitthankasem and Sissades Tongsima, National Biobank of Thailand, National Science and Technology Development Agency, Pathum Thani, Thailand, E-mails: rujipat.was@nstda.or.th and sissades.ton@nstda.or.th. Nawarat Posuwan, Chulabhorn International College of Medicine, Thammasat University, Rangsit Campus, Patum Thani, Thailand, E-mail: nawarat.po@gmail.com. Napaporn Pimsing and Saranya Ngamnimit, Phetchabun Provincial Public Health Office, Phetchabun, Thailand, E-mails: napaporn.tu16@gmail.com and saranyangamnimit@gmail.com. Wijittra Phaengkha, Nam Nao Hospital, Nam Nao District, Phetchabun, Thailand, E-mail: dr.zontok12@gmail.com. Preeyaporn Vichaiwattana, Ilada Thongpan, Sompong Vongpunsawad, and Yong Poovorawan, Center of Excellence in Clinical Virology, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand, E-mails: preeya_teiy@hotmail.com, ilada.cu09@gmail.com, sompong.vongpunsawad@gmail.com, and yong.p@chula.ac.th

Copyright:
© The American Society of Tropical Medicine and Hygiene 2022
Received:
22 Sep 2021
|
Accepted:
06 Jan 2022
|
Published Online:
28 Feb 2022
Cover The American Journal of Tropical Medicine and Hygiene
The American Journal of Tropical Medicine and Hygiene
Print ISSN:
0002-9637
Online ISSN:
1476-1645
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