2022
DOI: 10.1128/spectrum.02437-21
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Three-Stage Pooled Plasma Hepatitis C Virus RNA Testing for the Identification of Acute HCV Infections in At-Risk Populations

Abstract: Our three-stage pooled plasma HCV RNA testing successfully identified HCV viremia in high-risk PLWH with a testing cost reduction of 84.5%. Simulation analysis offered detailed information regarding the selection of pool and mini-pool sizes in settings of different HCV epidemiology and the performance of HCV RNA testing to optimize the cost reduction.

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Cited by 14 publications
(21 citation statements)
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“…With the rapid spread of HCV infection mainly among PLWH who are MSM worldwide in the past 2 decades ( 20 ), the HCVcAg assay has also been evaluated as an alternative HCV screening tool to identify new HCV infections among PLWH ( 21 , 22 ) or for PLWH with acute HCV infections ( 23 ). Despite the compromised performance in the specimens with lower plasma HCV RNA loads, the HCVcAg assay could also be a cost-saving diagnostic tool for recently acquired HCV infections, given the high HCV RNA loads in the setting of recently acquired HCV infections, with a mean plasma HCV RNA load of 6.4 log 10 IU/mL ( 15 , 24 ), especially in the high-risk populations requiring repeat testing. Among PLWH with acute HCV infection, the sensitivity of the HCVcAg assay ranges from 89% to 100% and its specificity from 95% to 100% ( 21 23 ).…”
Section: Discussionmentioning
confidence: 99%
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“…With the rapid spread of HCV infection mainly among PLWH who are MSM worldwide in the past 2 decades ( 20 ), the HCVcAg assay has also been evaluated as an alternative HCV screening tool to identify new HCV infections among PLWH ( 21 , 22 ) or for PLWH with acute HCV infections ( 23 ). Despite the compromised performance in the specimens with lower plasma HCV RNA loads, the HCVcAg assay could also be a cost-saving diagnostic tool for recently acquired HCV infections, given the high HCV RNA loads in the setting of recently acquired HCV infections, with a mean plasma HCV RNA load of 6.4 log 10 IU/mL ( 15 , 24 ), especially in the high-risk populations requiring repeat testing. Among PLWH with acute HCV infection, the sensitivity of the HCVcAg assay ranges from 89% to 100% and its specificity from 95% to 100% ( 21 23 ).…”
Section: Discussionmentioning
confidence: 99%
“…Further assessments of the turnaround time required and direct and indirect costs incurred between pooled-plasma HCV RNA testing and individual HCVcAg testing are warranted in different epidemiologic and clinical settings. In our study, it took about 9 h to go through stages 1 to 3 (approximately 2.7 h for each stage; see Materials and Methods) for pooled-plasma HCV RNA testing to get the results and 30 min for the HCVcAg assay ( 15 ). Fourth, since the prevalence of a disease of interest will have an impact on the performance of an assay, our findings can only be applied to settings with an overall prevalence of HCV viremia of 3.8% (62/1,639 in our study) of all samples tested and may not be generalizable to other populations with different prevalences of HCV viremia.…”
Section: Discussionmentioning
confidence: 99%
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“…To detect HCV reinfection, PLWH underwent testing for plasma HCV RNA periodically after completing their DAA treatment. During the observation period between June 2019 and December 2021, pooled plasma HCV RNA testing was performed every 3 months to detect HCV viremia [ 21 ]. In short, plasma samples from 20 individuals were pooled together for HCV RNA testing, and subsequent testing of mini-pools consisting of 5 samples would be performed if the initial testing was positive; and testing of individual samples would be performed for the mini-pooled samples tested positive for HCV RNA.…”
Section: Methodsmentioning
confidence: 99%
“…The detection of HCV RNA was performed using the Roche Cobas ® 6800 system (AmpliPrep HCV Test, v2.0, Roche, USA), with a detection limit of 15 IU/ml. To facilitate early detection of HCV viremia and linkage to DAA treatments, PLWH who received a diagnosis of sexually transmitted infection (STI), had elevated aminotransferases, or achieved HCV clearance spontaneously or with DAAs were enrolled in another prospective study using three-stage pooled-plasma HCV RNA testing every three months to detect HCV viremia for 12 months after June 2019 [ 26 ]. In brief, plasma samples from 20 PLWH were pooled together for HCV RNA testing, and subsequent testing of mini-pools consisting of five samples would be performed if the initial test was positive; testing of individual samples would be performed for the mini-pooled samples tested positive for HCV RNA.…”
Section: Methodsmentioning
confidence: 99%