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In‐field evaluation of Xpert® HCV viral load Fingerstick assay in people who inject drugs in Tanzania
Author(s) -
Mohamed Zameer,
Mbwambo Jessie,
Rwegasha John,
Mgiicodem,
Doulla Basra,
Mwakale Promise,
Tuaillon Edouard,
Chevaliez Stephane,
Shimakawa Yusuke,
TaylorRobinson Simon D.,
Thursz Mark R.,
Brown Ashley S.,
Lemoine Maud
Publication year - 2020
Publication title -
liver international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.873
H-Index - 110
eISSN - 1478-3231
pISSN - 1478-3223
DOI - 10.1111/liv.14315
Subject(s) - fingerstick , medicine , genexpert mtb/rif , tanzania , point of care , hepatitis c virus , viral load , hepatitis c , virology , tuberculosis , immunology , human immunodeficiency virus (hiv) , virus , mycobacterium tuberculosis , diabetes mellitus , pathology , environmental planning , endocrinology , environmental science
Background Although novel hepatitis C virus (HCV) RNA point‐of‐care technology has the potential to enhance the diagnosis in resource‐limited settings, very little real‐world validation of their utility exists. We evaluate the performance of HCV RNA quantification using the Xpert ® HCV viral load Fingerstick assay (Xpert ® HCV VL Fingerstick assay) as compared to the World Health Organisation pre‐qualified plasma Xpert ® HCV VL assay among people who inject drugs (PWID) attending an opioid agonist therapy (OAT) clinic in Dar‐es‐Salaam, Tanzania. Methods Between December 2018 and February 2019, consecutive HCV seropositive PWID attending the OAT clinic provided paired venous and Fingerstick samples for HCV RNA quantification. These were processed onsite using the GeneXpert ® platform located at the Central tuberculosis reference laboratory. Results A total of 208 out of 220 anti‐HCV‐positive participants recruited (94.5%) had a valid Xpert ® HCV VL result available; 126 (61%; 95% CI 53.8‐67.0) had detectable and quantifiable HCV RNA. About 188 (85%) participants had paired plasma and Fingerstick whole blood samples; the sensitivity and specificity for the quantification of HCV RNA levels were 99.1% and 98.7% respectively. There was an excellent correlation ( R 2 = .95) and concordance (mean difference 0.13 IU/mL, (95% CI −0.9 to 0.16 IU/mL) in HCV RNA levels between plasma samples and Fingerstick samples. Conclusion This study found excellent performance of the Xpert ® HCV VL Fingerstick assay for HCV RNA detection and quantification in an African‐field setting. Its clinical utility represents an important watershed in overcoming existing challenges to HCV diagnosis, which should play a crucial role in HCV elimination in Africa.