Validity of a point-of-care viral load kit for hepatitis B in a low-income setting

Woldemedihn, Gezahegn; Rueegg, Corina S.; Berhe, Nega; Desalegn, Hailemichael; Aberra, Hanna; Johannessen, Asgeir

doi:10.1016/s0168-8278(20)32120-6

Cited by 2 publications

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“…It is worth noting that the Xpert HBV Viral Load assay also has the potential of being used for point of care molecular testing, as demonstrated by the studies by Gupta et al, Woldemedihn et al,and Jackson et al [16,18,19], especially in developing countries.…”

Section: Discussionmentioning

confidence: 99%

Multicenter Evaluation of the Cepheid Xpert® HBV Viral Load Test

et al. 2021

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Accurate measurement of the hepatitis B virus (HBV) DNA is important for the management of patients with chronic HBV infection. Here, the performance of the Xpert® HBV Viral Load test (Xpert HBV Viral Load) versus the Roche COBAS® Ampliprep/COBAS® TaqMan® system (CAP/CTM HBV) HBV test v2.0 was evaluated. From September 2017 to December 2017, a total of 876 prospectively collected or archived serum or EDTA plasma specimens from subjects chronically infected with HBV were tested using the Xpert HBV Viral Load and the CAP/CTM HBV v2.0 assays. Of the 876 specimens tested, 560 were within the quantitative range of both assays. The agreement between the two methods was 90.0%. No difference in plasma or serum samples was observed. Deming regression analysis showed a good correlation of the Xpert HBV Viral Load assay with the CAP/CTM HBV v2.0 assay. The Bland–Altman analysis showed a good agreement between the results of the Xpert HBV Viral Load assay and the CAP/CTM HBV assay, with a mean difference (±1.96 standard deviation) of 0.0091 ± 0.3852 Log IU/mL. Comparing the two assays, only nineteen specimens (2.1%) had a difference greater than 1.96 times the standard deviation. The Xpert® HBV Viral Load test is suitable for monitoring patients with HBV infection and is useful in diagnostic settings.

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Section: Discussionmentioning

confidence: 99%

Multicenter Evaluation of the Cepheid Xpert® HBV Viral Load Test

et al. 2021

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“…Recently, Cepheid (US) commercialized a point‐of‐care HBV DNA PCR kit (Xpert ® ), and a few studies validated its diagnostic performance in resource‐limited countries 34 . According to the Foundation for Innovative New Diagnostics (FIND), the negotiated price of Xpert HBV viral load cartridge in LMICs is US$ 14.90 per assay, and that of a standard four‐module system is US$ 17,500 35 .…”

Section: Discussionmentioning

confidence: 99%