Premium
Field evaluation of GeneXpert ® (Cepheid) HCV performance for RNA quantification in a genotype 1 and 6 predominant patient population in Cambodia
Author(s) -
Iwamoto Momoko,
Calzia Aurelie,
Dublineau Amelie,
Rouet François,
Nouhin Janin,
Yann Sokchea,
Pin Sophorn,
Sun Chhorvy,
Sann Kimchamroeun,
Dimanche Chhit,
Lastrucci Celine,
Coulborn Rebecca M.,
Maman David,
Dousset JeanPhilippe,
Loarec Anne
Publication year - 2019
Publication title -
journal of viral hepatitis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.329
H-Index - 100
eISSN - 1365-2893
pISSN - 1352-0504
DOI - 10.1111/jvh.13002
Subject(s) - genexpert mtb/rif , medicine , virology , population , genotype , hepatitis c virus , point of care , viral load , human immunodeficiency virus (hiv) , tuberculosis , biology , virus , sputum , pathology , gene , biochemistry , environmental health
GeneXpert ® (Cepheid) is the only WHO prequalified platform for hepatitis C virus ( HCV ) nucleic acid amplification testing that is suitable for point‐of‐care use in resource‐limited contexts. However, its application is constrained by the lack of evidence on genotype 6 ( GT 6) HCV . We evaluated its field performance among a patient population in Cambodia predominantly infected with GT 6. Between August and September 2017, we tested plasma samples obtained from consenting patients at Médecins Sans Frontières’ HCV clinic at Preah Kossamak Hospital for HCV viral load ( VL ) using GeneXpert ® and compared its results to those obtained using COBAS ® AmpliPrep/Cobas ® TaqMan ® HCV Quantitative Test, v2.0 (Roche) at the Institut Pasteur du Cambodge. Among 769 patients, 77% of the seropositive patients (n = 454/590) had detectable and quantifiable VL using Roche and 43% (n = 195/454) were GT 6. The sensitivity and specificity of GeneXpert ® against Roche were 100% (95% CI 99.2, 100.0) and 98.5% (95% CI 94.8, 99.8). The mean VL difference was −0.01 (95% CI −0.05, 0.02) log 10 IU/mL for 454 samples quantifiable on Roche and −0.07 (95% CI −0.12, −0.02) log 10 IU/mL for GT 6 (n = 195). The limit of agreement ( LOA ) was −0.76 to 0.73 log 10 IU/mL for all GT s and −0.76 to 0.62 log 10 IU /mL for GT 6. Twenty‐nine GeneXpert ® results were outside the LOA . Frequency of error and the median turnaround time ( TAT ) for GeneXpert ® were 1% and 0 days (4 days using Roche). We demonstrated that the GeneXpert ® HCV assay has good sensitivity, specificity, quantitative agreement, and TAT in a real‐world, resource‐limited clinical setting among GT 6 HCV patients.