Evaluation of the Xpert HCV Viral Load point-of-care assay from venepuncture-collected and finger-stick capillary whole-blood samples: a cohort study

The Lancet Gastroenterology and Hepatology

Volumn 2, Issue 7, 2017, Pages 514-520

  Grebely, Jason ^a   Lamoury, Francois M J ^a   Hajarizadeh, Behzad ^a   Mowat, Yasmin ^a   Marshall, Alison D ^a   Bajis, Sahar ^a   Marks, Philippa ^a   Amin, Janaki ^a,c   Smith, Julie ^d   Edwards, Michael ^e   Gorton, Carla ^f   Ezard, Nadine ^b,g   Persing, David ^h   Kleman, Marika ⁱ   Cunningham, Philip ^j   Catlett, Beth ^j   Dore, Gregory J ^a   Applegate, Tanya L ^a  

^a UNIVERSITY OF NEW SOUTH WALES   (Australia)

^b UNIVERSITY OF NEW SOUTH WALES   (Australia)

^c MACQUARIE UNIVERSITY   (Australia)

^d St Vincent de Paul Society NSW Support Services   (Australia)

^e SOUTH WESTERN SYDNEY LOCAL HEALTH DISTRICT   (Australia)

^f Cairns District Health Service   (Australia)

^g ST VINCENT S HOSPITAL   (Australia)

^h CEPHEID   (United States)

ⁱ Cepheid   (Sweden)

^j Lowy Packer Building   (Australia)

more..

Author keywords

[No Author keywords available]

Indexed keywords

VIRUS RNA;

ADULT; ANTIVIRAL THERAPY; ARTICLE; BLOOD SAMPLING; COHORT ANALYSIS; CONTROLLED STUDY; DIAGNOSTIC TEST ACCURACY STUDY; DRUG USE; FEMALE; FINGER STICK CAPILLARY; HEPATITIS C VIRUS; HUMAN; INJECTING DRUG USE; MAJOR CLINICAL STUDY; MALE; OBSERVATIONAL STUDY; OPEN STUDY; PRIORITY JOURNAL; REAL TIME POLYMERASE CHAIN REACTION; SENSITIVITY AND SPECIFICITY; TRANSGENDER; VEIN PUNCTURE; VIRAL LOAD TESTING; VIRUS LOAD; XPERT HCV VIRAL LOAD TEST; BLOOD; CAPILLARY; CLINICAL TRIAL; EVALUATION STUDY; GENETICS; HEPACIVIRUS; HEPATITIS C; ISOLATION AND PURIFICATION; MIDDLE AGED; MULTICENTER STUDY; PHLEBOTOMY; POINT OF CARE TESTING; PROCEDURES; VIROLOGY;

ADULT; CAPILLARIES; FEMALE; HEPACIVIRUS; HEPATITIS C; HUMANS; MALE; MIDDLE AGED; PHLEBOTOMY; POINT-OF-CARE TESTING; RNA, VIRAL; SENSITIVITY AND SPECIFICITY; VIRAL LOAD;

EID: 85020535343     PISSN: 24681253     EISSN: None     Source Type: Journal    
DOI: 10.1016/S2468-1253(17)30075-4     Document Type: Article

References (31)

1. Hajarizadeh, B, Grebely, J, Dore, GJ, Epidemiology and natural history of HCV infection. Nat Rev Gastroenterol Hepatol 10 (2013), 553–562.
2. The Polaris Observatory HCV Collaborators. Global prevalence and genotype distribution of hepatitis C virus infection in 2015: a modelling study. Lancet Gastroenterol Hepatol 2 (2017), 161–176.
3. Saraswat, V, Norris, S, de Knegt, RJ, et al. Historical epidemiology of hepatitis C virus (HCV) in select countries—volume 2. J Viral Hepat 22:suppl 1 (2015), 6–25.
4. Liakina, V, Hamid, S, Tanaka, J, et al. Historical epidemiology of hepatitis C virus (HCV) in select countries—volume 3. J Viral Hepat 22:suppl 4 (2015), 4–20.
5. Bruggmann, P, Berg, T, Ovrehus, AL, et al. Historical epidemiology of hepatitis C virus (HCV) in selected countries. J Viral Hepat 21:suppl 1 (2014), 5–33.
6. Easterbrook, PJ, Group, WHOGD, Who to test and how to test for chronic hepatitis C infection—2016 WHO testing guidance for low- and middle-income countries. J Hepatol 65:suppl 1 (2016), S46–S66.
7. Zhou, K, Fitzpatrick, T, Walsh, N, et al. Interventions to optimise the care continuum for chronic viral hepatitis: a systematic review and meta-analyses. Lancet Infect Dis 16 (2016), 1409–1422.
8. Cullen, W, Stanley, J, Langton, D, Kelly, Y, Staines, A, Bury, G, Hepatitis C infection among injecting drug users in general practice: a cluster randomised controlled trial of clinical guidelines' implementation. Br J Gen Pract 56 (2006), 848–856.
9. Rosenberg, SD, Goldberg, RW, Dixon, LB, et al. Assessing the STIRR model of best practices for blood-borne infections of clients with severe mental illness. Psychiatr Serv 61 (2010), 885–891.
10. Sahajian, F, Bailly, F, Vanhems, P, et al. A randomized trial of viral hepatitis prevention among underprivileged people in the Lyon area of France. J Public Health 33 (2011), 182–192.
11. Lacey, C, Ellen, S, Devlin, H, Wright, E, Mijch, A, Hepatitis C in psychiatry inpatients: testing rates, prevalence and risk behaviours. Australas Psychiatry 15 (2007), 315–319.
12. Meyer, JP, Moghimi, Y, Marcus, R, Lim, JK, Litwin, AH, Altice, FL, Evidence-based interventions to enhance assessment, treatment, and adherence in the chronic hepatitis C care continuum. Int J Drug Policy 26 (2015), 922–935.
13. Hickman, M, McDonald, T, Judd, A, et al. Increasing the uptake of hepatitis C virus testing among injecting drug users in specialist drug treatment and prison settings by using dried blood spots for diagnostic testing: a cluster randomized controlled trial. J Viral Hepat 15 (2008), 250–254.
14. Abou-Saleh, MT, Rice, P, Foley, S, Hepatitis C testing in drug users using the dried blood spot test and the uptake of an innovative self-administered DBS test. Addict Disord Their Treat 12 (2013), 40–49.
15. Tait, JM, Stephens, BP, McIntyre, P, Evans, M, Dillon, JF, Dry blood spot testing for hepatitis C in people who injected drugs: reaching the populations other tests cannot reach. J Hepatol, 58, 2013, S204.
16. McLeod, A, Weir, A, Aitken, C, et al. Rise in testing and diagnosis associated with Scotland's Action Plan on Hepatitis C and introduction of dried blood spot testing. J Epidemiol Community Health 68 (2014), 1182–1188.
17. 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 26 (2015), 1050–1055.
18. 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 39 (2014), 922–934.
19. 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, 2, 2015, ofv162.
20. Beckwith, CG, Kurth, AE, Bazerman, LB, et al. A pilot study of rapid hepatitis C virus testing in the Rhode Island Department of Corrections. J Public Health 38 (2016), 130–137.
21. Wong, VW, Wong, GL, Chim, AM, et al. Targeted hepatitis C screening among ex-injection drug users in the community. J Gastroenterol Hepatol 29 (2014), 116–120.
22. Jewett, A, Smith, BD, Garfein, RS, Cuevas-Mota, J, Teshale, EH, Weinbaum, CM, Field-based performance of three pre-market rapid hepatitis C virus antibody assays in STAHR (Study to Assess Hepatitis C Risk) among young adults who inject drugs in San Diego, CA. J Clin Virol 54 (2012), 213–217.
23. Smith, BD, Drobeniuc, J, Jewett, A, et al. Evaluation of three rapid screening assays for detection of antibodies to hepatitis C virus. J Infect Dis 204 (2011), 825–831.
24. Smith, BD, Teshale, E, Jewett, A, et al. Performance of premarket rapid hepatitis C virus antibody assays in 4 national human immunodeficiency virus behavioral surveillance system sites. Clin Infect Dis 53 (2011), 780–786.
25. Drobnik, A, Judd, C, Banach, D, Egger, J, Konty, K, Rude, E, Public health implications of rapid hepatitis C screening with an oral swab for community-based organizations serving high-risk populations. Am J Public Health 101 (2011), 2151–2155.
26. Grebely, J, Page, K, Sacks-Davis, R, et al. The effects of female sex, viral genotype, and IL28B genotype on spontaneous clearance of acute hepatitis C virus infection. Hepatology 59 (2014), 109–120.
27. Marshall, AD, Micallef, M, Erratt, A, et al. Liver disease knowledge and acceptability of non-invasive liver fibrosis assessment among people who inject drugs in the drug and alcohol setting: The LiveRLife Study. Int J Drug Policy 26 (2015), 984–991.
28. WHO. WHO guidelines on drawing blood: best practices in phlebotomy, 2010, World Health Organization, Geneva.
29. Daniel, HD, Grant, PR, Garson, JA, Tedder, RS, Chandy, GM, Abraham, P, Quantitation of hepatitis C virus using an in-house real-time reverse transcriptase polymerase chain reaction in plasma samples. Diagn Microbiol Infect Dis 61 (2008), 415–420.
30. McHugh, MP, Wu, AH, Chevaliez, S, Pawlotsky, JM, Hallin, M, Templeton, KE, Multicentre evaluation of the Cepheid Xpert® Hepatitis C Virus (HCV) Viral Load assay. J Clin Microbiol, 2017, 10.1128/JCM.02460-16 published March 8.
31. Gupta, E, Agarwala, P, Kumar, G, Maiwall, R, Sarin, SK, Point-of-care testing (POCT) in molecular diagnostics: performance evaluation of GeneXpert HCV RNA test in diagnosing and monitoring of HCV infection. J Clin Virol 88 (2017), 46–51.