Michael J Vinikoor1, Samuel Zürcher2, Kalo Musukuma3, Obert Kachuwaire4, Andri Rauch5, Benjamin H Chi6, Meri Gorgievski2, Marcel Zwahlen7, Gilles Wandeler8. 1. Department of Medicine, University of Alabama at Birmingham, USA; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia; School of Medicine, University of Zambia, Lusaka, Zambia. Electronic address: mjv3@uab.edu. 2. Institute of Infectious Diseases, University of Bern, Switzerland. 3. Centre for Infectious Disease Research in Zambia, Lusaka, Zambia; School of Medicine, University of Zambia, Lusaka, Zambia. 4. Centre for Infectious Disease Research in Zambia, Lusaka, Zambia. 5. Department of Infectious Diseases, University Hospital Bern, Switzerland. 6. Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, USA. 7. Institute of Social and Preventive Medicine, University of Bern, Switzerland. 8. Department of Infectious Diseases, University Hospital Bern, Switzerland; Institute of Social and Preventive Medicine, University of Bern, Switzerland; Department of Infectious Diseases, University of Dakar, Senegal.
Abstract
BACKGROUND: Access to hepatitis B viral load (VL) testing is poor in sub-Saharan Africa (SSA) due to economic and logistical reasons. OBJECTIVES: To demonstrate the feasibility of testing dried blood spots (DBS) for hepatitis B virus (HBV) VL in a laboratory in Lusaka, Zambia, and to compare HBV VLs between DBS and plasma samples. STUDY DESIGN: Paired plasma and DBS samples from HIV-HBV co-infected Zambian adults were analyzed for HBV VL using the COBAS AmpliPrep/COBAS TaqMan HBV test (Version 2.0) and for HBV genotype by direct sequencing. We used Bland-Altman analysis to compare VLs between sample types and by genotype. Logistic regression analysis was conducted to assess the probability of an undetectable DBS result by plasma VL. RESULTS: Among 68 participants, median age was 34 years, 61.8% were men, and median plasma HBV VL was 3.98logIU/ml (interquartile range, 2.04-5.95). Among sequenced viruses, 28 were genotype A1 and 27 were genotype E. Bland-Altman plots suggested strong agreement between DBS and plasma VLs. DBS VLs were on average 1.59logIU/ml lower than plasma with 95% limits of agreement of -2.40 to -0.83log IU/ml. At a plasma VL ≥2,000IU/ml, the probability of an undetectable DBS result was 1.8% (95% CI: 0.5-6.6). At plasma VL ≥20,000IU/ml this probability reduced to 0.2% (95% CI: 0.03-1.7). CONCLUSIONS: In a Zambian laboratory, we observed strong agreement between DBS and plasma VLs and high sensitivity in DBS at plasma VL ≥2,000IU/ml. As HBV treatment expands, DBS could increase access to HBV VL testing and care in SSA settings.
BACKGROUND: Access to hepatitis B viral load (VL) testing is poor in sub-Saharan Africa (SSA) due to economic and logistical reasons. OBJECTIVES: To demonstrate the feasibility of testing dried blood spots (DBS) for hepatitis B virus (HBV) VL in a laboratory in Lusaka, Zambia, and to compare HBV VLs between DBS and plasma samples. STUDY DESIGN: Paired plasma and DBS samples from HIV-HBV co-infected Zambian adults were analyzed for HBV VL using the COBAS AmpliPrep/COBAS TaqMan HBV test (Version 2.0) and for HBV genotype by direct sequencing. We used Bland-Altman analysis to compare VLs between sample types and by genotype. Logistic regression analysis was conducted to assess the probability of an undetectable DBS result by plasma VL. RESULTS: Among 68 participants, median age was 34 years, 61.8% were men, and median plasma HBV VL was 3.98logIU/ml (interquartile range, 2.04-5.95). Among sequenced viruses, 28 were genotype A1 and 27 were genotype E. Bland-Altman plots suggested strong agreement between DBS and plasma VLs. DBS VLs were on average 1.59logIU/ml lower than plasma with 95% limits of agreement of -2.40 to -0.83log IU/ml. At a plasma VL ≥2,000IU/ml, the probability of an undetectable DBS result was 1.8% (95% CI: 0.5-6.6). At plasma VL ≥20,000IU/ml this probability reduced to 0.2% (95% CI: 0.03-1.7). CONCLUSIONS: In a Zambian laboratory, we observed strong agreement between DBS and plasma VLs and high sensitivity in DBS at plasma VL ≥2,000IU/ml. As HBV treatment expands, DBS could increase access to HBV VL testing and care in SSA settings.
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