Direct comparison of three residual risk models for hepatitis B virus window period infections using updated input parameters.
NAT testing
residual risk estimation
serological testing
Journal
Vox sanguinis
ISSN: 1423-0410
Titre abrégé: Vox Sang
Pays: England
ID NLM: 0413606
Informations de publication
Date de publication:
Apr 2020
Apr 2020
Historique:
received:
12
07
2019
revised:
21
11
2019
accepted:
24
12
2019
pubmed:
22
1
2020
medline:
21
10
2020
entrez:
22
1
2020
Statut:
ppublish
Résumé
Comparison of two models for estimating residual transfusion transmission risk by NAT screened window period (WP) donations in South African repeat donors gave identical results for HIV but not for HBV. In order to understand discrepant HBV modelling outcomes, the values of input parameters in three HBV WP risk models were reviewed and subsequently applied to the same South African screening data generated by HBsAg PRISM and two NAT assays (Ultrio and Ultrio Plus). Two of the models were also compared using individual donation (ID)-NAT screening data from different geographical regions. Values of input parameters were derived from two published data sources and used in three risk models [(1) the incidence rate-WP risk day equivalent model, (2) the NAT yield WP ratio model and (3) the anti-HBc-negative HBsAg yield period ratio model] and subsequently applied to the same ID-NAT screening data. The HBV WP transmission risk in South African repeat donations during a one-year Ultrio Plus NAT screening period was estimated as 22, 43 and 17 per million, respectively, for the three models, as compared to 56, 117 and 48 per million for HBsAg PRISM screening. The approximate two-fold higher estimate calculated with the NAT yield WP ratio model was corroborated in repeat donations from three of four regions in a multi-regional study. When another set of model input values (with shorter viraemia periods and a higher proportion of acute occult infections) was applied to the South African screening data, the relative difference in risk estimates between the three models became smaller. Window period risk modelling for HBV is more complex than for HIV. Multiple factors affect the modelling outcomes. These include the values used for the length of transient HBsAg and HBV-DNA-positive phases, the proportion of acute occult and vaccine breakthrough infections and the assumption of random appearance of donors throughout the entire acute resolving infection phase. A substantial proportion of HBV WP NAT yields have very low viral load and lack donor follow-up data calling into question their definitive classification into the early acute (infectious) replication stage. Since these possible WP NAT yields most highly impact the NAT yield WP ratio model, we recommend relying on the more conservative estimates of the incidence rate-WP risk day equivalent model.
Sections du résumé
BACKGROUND AND OBJECTIVES
OBJECTIVE
Comparison of two models for estimating residual transfusion transmission risk by NAT screened window period (WP) donations in South African repeat donors gave identical results for HIV but not for HBV. In order to understand discrepant HBV modelling outcomes, the values of input parameters in three HBV WP risk models were reviewed and subsequently applied to the same South African screening data generated by HBsAg PRISM and two NAT assays (Ultrio and Ultrio Plus). Two of the models were also compared using individual donation (ID)-NAT screening data from different geographical regions.
METHODS
METHODS
Values of input parameters were derived from two published data sources and used in three risk models [(1) the incidence rate-WP risk day equivalent model, (2) the NAT yield WP ratio model and (3) the anti-HBc-negative HBsAg yield period ratio model] and subsequently applied to the same ID-NAT screening data.
RESULTS
RESULTS
The HBV WP transmission risk in South African repeat donations during a one-year Ultrio Plus NAT screening period was estimated as 22, 43 and 17 per million, respectively, for the three models, as compared to 56, 117 and 48 per million for HBsAg PRISM screening. The approximate two-fold higher estimate calculated with the NAT yield WP ratio model was corroborated in repeat donations from three of four regions in a multi-regional study. When another set of model input values (with shorter viraemia periods and a higher proportion of acute occult infections) was applied to the South African screening data, the relative difference in risk estimates between the three models became smaller.
CONCLUSIONS
CONCLUSIONS
Window period risk modelling for HBV is more complex than for HIV. Multiple factors affect the modelling outcomes. These include the values used for the length of transient HBsAg and HBV-DNA-positive phases, the proportion of acute occult and vaccine breakthrough infections and the assumption of random appearance of donors throughout the entire acute resolving infection phase. A substantial proportion of HBV WP NAT yields have very low viral load and lack donor follow-up data calling into question their definitive classification into the early acute (infectious) replication stage. Since these possible WP NAT yields most highly impact the NAT yield WP ratio model, we recommend relying on the more conservative estimates of the incidence rate-WP risk day equivalent model.
Substances chimiques
Hepatitis B Surface Antigens
0
Types de publication
Comparative Study
Journal Article
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
133-145Informations de copyright
© 2020 International Society of Blood Transfusion.
Références
Vermeulen M, Lelie N, Coleman C, et al.: Assessment of HIV transfusion transmission risk in South Africa: a 10-year analysis following implementation of individual donation nucleic acid amplification technology testing and donor demographics eligibility changes. Transfusion 2019; 59:267-276
Weusten J, Vemeulen M, Van Drimmelen H, et al.: Refinement of a viral transmission risk model for blood donations in seroconversion window phase screened by nucleic acid testing in different pool sizes and repeat test algorithms. Transfusion 2011; 51:203-215
Busch MP, Glynn SA, Stramer SL, et al.: A new strategy for estimating risks of transfusion-transmitted viral infections based on rates of detection of recently infected donors. Transfusion 2005; 45:254-264
Vermeulen M, Dickens C, Lelie PN, et al.: Hepatitis B virus transmission by blood transfusion during four years of individual donation nucleic acid testing in South Africa: estimated and observed window period risk. Transfusion 2011; 52:880-892
Vermeulen M, Van Drimmelen H, Coleman C, et al.: Reassessment of hepatitis B virus testing methods and window periods using screening data of South African blood donors. Transfusion 2019; 59:2922-2930
Zou S, Stramer SL, Notari EP, et al.: Current incidence and residual risk of hepatitis B infection among blood donors in the United States. Transfusion 2009; 49:1609-1620
Stramer SL, Notari EP, Krysztof DE, et al.: Hepatitis B virus testing by minipool nucleic acid testing: does it improve blood safety? Transfusion 2013; 53:2449-2458
Korelitz JJ, Busch MP, Kleinman SH, et al.: A method for estimating hepatitis B virus incidence rates in volunteer blood donors. National Heart, Lung, and Blood Institute Retrovirus Epidemiology Donor Study. Transfusion 1997; 37:634-40
Yoshikawa A, Gotanda Y, Minegishi K, et al.: Lengths of hepatitis B viremia and antigenemia in blood donors:preliminary evidence of occult (hepatitis B surface antigen-negative) infection in the acute stage. Transfusion 2007; 47:1162-1171
Manzini P, Abate ML, Valpreda C, et al.: Evidence of acute primary occult hepatitis B virus infection in Italian repeat blood donor. Transfusion 2009; 49:757-764
Bremer CM, Saniewski M, Wend U, et al.: Transient occult hepatitis B virus infection in a blood donor with high viremia. Transfusion 2009; 49:1621-1629
Stramer S, Wend U, Candotti D, et al.: Occurrence and characterization of naturally acquired hepatitis B infection among vaccinated blood donors. N Engl J Med 2011; 364:236-247
Lelie N, Bruhn R, Busch M, et al.: and the International NAT Study Group. Detection of different categories of hepatitis B virus (HBV) infection in a multi-regional study comparing the clinical sensitivity of HBsAg and HBV DNA testing. Transfusion 2017; 57:841-849
Assal A, Barlet V, Deschaseaux M, et al.: Sensitivity of two hepatitis B virus, hepatitis C viris (HCV) and human immunodeficiency virus (HIV) nucleic acid test systems relative to hepatitis B surface antigen, anti-HCV, anti-HIV and p24/anti-HIV combination assays in seroconversion panels. Transfusion 2009; 49:301-310
Van Drimmelen AAJ, Assal A, Lelie PN: Correlation between HBsAg and HBV-DNA concentration in seroconversion ramp-up phase allows for modeling window periods from analytical sensitivity studies of HBV assays. Vox Sang 2010; 99(Suppl 1): 78-79 (Abstract 5D-S45-05)
Vermeulen M, Coleman C, Mitchel J, et al.: Lelie N Sensitivity of individual donation- and minipool-nucleic acid amplification test options in detecting window period and occult hepatitis B virus infections. Transfusion 2013; 53:2459-2466
Yoshikawa A, Gotanda Y, Itabashi M, et al.: Hepatitis B NAT virus-positive blood donors in the early stages of HBV infection: analysis of the window period and kinetics of HBV-DNA. Vox Sang 2005; 88:77-86
Biswas R, Tabor E, Hsia CC, et al.: Comparative sensitivity of HBV NATs and HBsAg assays for detection of acute HBV infection. Transfusion 2003; 43:788-798
Barker LF, Murray R: Relationship of virus dose to incubation time of clinical hepatitis and time of appearance of hepatitis associated antigen. Am J Med Sci 1972; 263:27-33
Mimms LT, Mosley JW, Hollinger FB, et al.: Effect of concurrent acute infection with hepatits C virus on acute hepatitis B virus infection. BMJ 1993; 307:1095-1097
Matsubara N, Kusano O, Sugamata Y, et al.: A novel hepatitis B virus surface antigen immunoassay as sensitive as hepatitis B virus nucleic acid testing in detecting early infection. Transfusion 2009; 49:585-595
Gerlich WH, Glebe D, Schüttler CG: Deficiencies in the standardization and sensitivity of diagnostic tests for hepatitis B virus. J Viral Hepatitis 2007; 14(Suppl. 1):16-21
Vermeulen M, Van Drimmelen H, Coleman C, et al.: A mathematical approach to estimate the efficacy of individual donation- and minipool-nucleic acid amplification test options in preventing transmission risk by window period and occult hepatitis B virus infections. Transfusion 2014; 54:2496-2504
Tsoi W-C, Lelie N, Lin C-K: Enhanced detection of hepatitis B virus in Hong Kong blood donors after introduction of a more sensitive transcription mediated amplification assay. Transfusion 2013; 53:2477-2400
Komiya Y, Katayama K, Yugi H, et al.: Minimum infectious dose of hepatitis B virus in chimpanzees and difference in the dynamics of viremia between genotype A and genotype C. Transfusion 2008; 48:286-294
Iudicone P, Miceli M, Palange M, et al.: Hepatitis B virus blood screening: impact of nucleic amplification technology testing implementation on identifying hepatitis B surface antigen non-reactive window period and chronic infections. Vox Sang 2009; 96:292-297
Bruhn R, Lelie N, Custer B, et al.: S and the International NAT Study Group. Prevalence of HIV-RNA and antibody in first, lapsed and repeat blood donations across five international regions and relative efficacy of alternative screening scenarios. Transfusion 2013; 53:2399-2412
Vermeulen M, Coleman C, Mitchel J, et al.: Lelie N Comparison of HIV assays in window phase and elite controller samples: viral load distribution and implications for transmission risk. Transfusion 2013; 53:2384-2398
Jordan A, Acker JP: Determining the volume of additive solution and residual plasma in whole blood filtered and buffy coat processed red cell concentrates. Transfus Med Hemother 2016; 43:133-6