Fingerstick Point-of-Care Test Allows for Single-Visit HCV Diagnoses

The Xpert® Hepatitis C Virus (HCV) Viral Load (VL) Fingerstick (Cepheid, Sunnyvale, CA) point-of-care test can detect active infection accurately from 100 µL of capillary whole blood in 1 hour, allowing for single-visit HCV diagnoses, according to an observational cohort study published in The Journal of Infectious Diseases.¹

Current HCV testing involves a 2-step diagnostic pathway requiring multiple visits to a practitioner and off-site phlebotomists.^2-7 Point-of-care HCV testing has been shown to increase testing and care.^8-12

Researchers in Australia evaluated the sensitivity and specificity of a redesigned prototype Xpert HCV VL fingerstick assay for HCV RNA detection (fingerstick) and the Xpert HCV VL assay (plasma) compared with the Abbott RealTime HCV VL (Abbott Laboratories, Des Plaines, IL) assay by venous puncture in 223 participants enrolled at drug treatment clinics and homeless services.¹

The researchers found that the sensitivity and specificity of the Xpert HCV VL assay (plasma) for HCV RNA quantification in samples collected by venepuncture were 100%. Likewise, the sensitivity and specificity of the Xpert HCV VL fingerstick assay for HCV RNA quantification in samples collected by fingerstick were also 100%.

Therefore, the fingerstick assay provides a substantial advantage over the plasma assay by avoiding the need for plasma separation and enables testing and diagnosis in 1 hour compared with 2 hours.

In the first study of its kind, the authors concluded that, “This study demonstrated 100% sensitivity and specificity of the Xpert® HCV VL fingerstick test compared with the Abbott RealTime HCV VL assay. This assay can detect active infection from a fingerstick sample in 1 hour, allowing single-visit HCV diagnosis.”¹

Disclosure: This research was partially funded by Merck Sharp & Dohme, Australia. Please see original reference for full list of authors’ disclosures.

References

1. Lamoury FMJ, Bajis S, Hajarizadeh B, et al. Evaluation of the Xpert® HCV viral load fingerstick point-of-care assay [published online March 9, 2018]. J Infect Dis. doi: 10.1093/infdis/jiy114
2. Yehia BR, Schranz AJ, Umscheid CA, Lo Re V 3rd. The treatment cascade for chronic hepatitis C virus infection in the United States: a systematic review and meta-analysis. PloS One. 2014;9:e101554.
3. Patel RC, Vellozzi C, Smith BD. Results of hepatitis C birth-cohort testing and linkage to care in selected U.S. sites, 2012-2014. Public Health Rep. 2016;131 Suppl 2:12-19.
4. Mera J, Vellozzi C, Hariri S, et al. Identification and clinical management of persons with chronic hepatitis C virus infection – Cherokee Nation, 2012-2015. MMWR Morb Mortal Wkly Rep. 2016;65:461-466.
5. Snow K, Scott N, Clothier HJ, MacLachlan JH, Cowie B. Limited provision of diagnostic services to Victorians living with hepatitis C antibodies, 2001-2012: a multi-level modelling analysis [published online August 14, 4016]. Aust N Z J Public Health. doi: 10.1111/1753-6405.12560
6. Janjua NZ, Kuo M, Yu A, et al. The population level cascade of care for hepatitis C in British Columbia, Canada: The BC Hepatitis Testers Cohort (BC-HTC). EBioMedicine. 2016;12:189-195.
7. Iversen J, Grebely J, Catlett B, Cunningham P, Dore GJ, Maher L. Estimating the cascade of hepatitis C testing, care and treatment among people who inject drugs in Australia. Int J Drug Policy. 2017;47:77-85.
8. Bajis S, Dore GJ, Hajarizadeh B, Cunningham EB, Maher L, Grebely J. Interventions to enhance testing, linkage to care and treatment uptake for hepatitis C virus infection among people who inject drugs: A systematic review. Int J Drug Policy. 2017;47:34-46.
9. Coats JT, Dillon JF. The effect of introducing point-of-care or dried blood spot analysis on the uptake of hepatitis C virus testing in high-risk populations: a systematic review of the literature. Int J Drug Policy. 2015;26:1050-1055.
10. Morano JP, Zelenev A, Lombard A, Marcus R, Gibson BA, Altice FL. Strategies for hepatitis C testing and linkage to care for vulnerable populations: point-of-care and standard HCV testing in a mobile medical clinic. J Community Health 2014;39:922-934.
11. Bottero J, Boyd A, Gozlan J, et al. Simultaneous human immunodeficiency virus-hepatitis B-hepatitis C point-of-care tests improve outcomes in linkage-to-care: results of a randomized control trial in persons without healthcare coverage. Open Forum Infect Dis. 2015;2(4):ofv162.
12. McAllister G, Innes H, McLeod A, et al. Uptake of hepatitis C specialist services and treatment following diagnosis by dried blood spot in Scotland. J Clin Virol. 2014;61:359-364.