Use of supplemental anti‐<scp>HB</scp>c testing of donors showing non‐discriminating reactive results in multiplex nucleic acid testing

Kang, Jae-won; Seo, Jong-Hyun; Youn, K. W.; Seo, Young Ik; Huh, Kwang; Choi, Gyeryung; Min, Hyukki; Oh, Do Hoon; Jo, Hyun Jung; Kim, J. N.

doi:10.1111/vox.12553

Cited by 8 publications

(8 citation statements)

References 12 publications

(17 reference statements)

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“…In this study, the percent of anti-HBc reactivity among non-discriminated donations (91.1%) was significantly higher than 47.5% was found in a random group of donors in a previous study ( p < 0.001), which indicated the background anti-HBc reactivity [28]. It was obviously higher than 13% for Ultrio and 57% for Ultrio Plus in New Zealand [26] and 47% in Korean donors’ population [27]. This strongly indicated that a number of the NDR donors had past HBV infection with low viral load occasionally captured by multiplex HBV, HCV, and HIV NAT, thus missed by discriminatory assays.…”

Section: Discussionmentioning

confidence: 67%

“…These donors still keep the right for future donation, raising high risk problem for blood safety. In this study, the occurrence of non-discriminators revealed that 0.21% donors screened using the Ultrio Plus assay in Shenzhen showed NDR results, more than two fold higher than New Zealand (0.09%) [26] and Korea (0.05%) [27], which may be associated with the different prevalence of HBV, distribution of genotype, sampling size of the studies, and the different testing assays and study protocols of different studies. In this study, the percent of anti-HBc reactivity among non-discriminated donations (91.1%) was significantly higher than 47.5% was found in a random group of donors in a previous study ( p < 0.001), which indicated the background anti-HBc reactivity [28].…”

Section: Discussionmentioning

confidence: 99%

“…The problem with NDR was that the manufacturer of Ultrio Plus stated that the multiplex assay was marginally more sensitive than the discriminatory assay for detecting HBV DNA [27]. This may be why some donations with low levels of HBV DNA produced non-discriminated results.…”

Section: Discussionmentioning

confidence: 99%

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Nearly half of Ultrio plus NAT non-discriminated reactive blood donors were identified as occult HBV infection in South China

Wen

et al. 2019

BMC Infect Dis

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Background Blood donor plasma samples were detected by the Ultrio Plus NAT system for HBV, HCV and HIV-1 in Shenzhen blood center, China. Reactive samples underwent further discriminatory testing of a single virus by the same methodology. A large number of cases of non-discriminated reactive (NDR) donors were found, leaving potential risk of transmitting HBV if not deferrals. This study identified those non-discriminated samples. Methods The NDR plasma samples from blood donation screening were detected and classified by additional molecular and serological tests. Molecular characterizations of DNA+ NDR were determined by sequencing analysis. Results A number of 259 (0.21%) NDR plasma samples from screening of 123,280 eligible blood donors were detected, which presented a higher rate (91.1%) of anti-HBc reactivity and nearly half (46.7%) of HBV DNA+ that classified as occult HBV infection (OBI). Most OBI strains were wild-type HBV, but some substitutions V168A, S174 N, V177A, Q129R/L/H, G145A/R in S region of genotype B (OBI B ) and T47K/V/A, P49H/L, Q101R/H/K, S174 N, L175S, V177A, T118 M/R/K, G145R/A/K/E, R160K/N in S region of genotype C (OBI C ) strains were identified in high frequency. Conclusion Nearly half of NDR blood samples were identified as OBI, in which a number of important mutations were detected. NDR donation might have potential risk for HBV transmission, but need to be further investigated.

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Section: Discussionmentioning

confidence: 67%

Section: Discussionmentioning

confidence: 99%

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Nearly half of Ultrio plus NAT non-discriminated reactive blood donors were identified as occult HBV infection in South China

Wen

et al. 2019

BMC Infect Dis

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“…At least two lines of evidence indicate that a proportion of NDR results with concomitant anti‐HBc reactivity may represent OBI. Firstly, donors with NDR results have a higher prevalence of anti‐HBc reactivity than those who are NAT non‐reactive . Additionally, one study has reported that the anti‐HBc prevalence in donors who test NDR is higher for those who are reactive when retested on the multiplex assay compared to those who are non‐reactive .…”

Section: The Interpretative Challenges Of Nucleic Acid Testing (Nat)mentioning

confidence: 99%

False positive viral marker results in blood donors and their unintended consequences

2018

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False positive (FP) viral marker results in blood donors continue to pose many challenges. Informing donors of FP results and subsequent deferral can result in stress and anxiety for donors and additional complexity and workload for blood services. Donor management strategies need to balance the requirement to minimise donor anxiety and inconvenience while maintaining sufficiency of supply. Decisions about how and when to inform donors of FP results and determine deferral periods can be difficult as FP results, while often transitory, can take up to several years to resolve. Additional complexities include the interpretation of indeterminate serological confirmatory testing without detectable viral RNA or non-discriminated NAT results with concomitant anti-HBc reactivity - both may be due to FP results, but the former may also represent past infection and the later may represent occult hepatitis B infection. In this review we discuss strategies to minimise indeterminate serological confirmatory results, possible donor deferral policies and the impact on donors when notified of FP results. We also provide some new data from Australia that address the challenge of interpreting non-discriminated NAT results with concomitant anti-HBc reactivity. Ultimately, the challenge is for each blood service to develop appropriate strategies for donor management, taking into account local information and requirements.

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“…There are relatively limited published data about the rates of FPs and the performance of specific algorithms implemented to manage donor deferral and eventual reentry . The strategies developed to manage donors with indeterminate or FP results are essentially based on the use of supplemental serological and molecular testing and donor follow‐up . Nevertheless, management strategies established in a given country might not be appropriate in another country due to differences in epidemiology, populations, and the reagents used.…”

mentioning

confidence: 99%

Follow‐up program for blood donors with unconfirmed screening results reveals a high false‐positive rate in Dalian, China

Deng¹,

Zang²,

Wang³

et al. 2020

Transfusion

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BACKGROUND Chinese blood donors with unconfirmed serological and/or molecular screening results are deferred permanently. This study investigated the implementation and performance of a follow‐up program aiming to improve the notification and management of deferred donors in Dalian, China. STUDY DESIGN AND METHODS From January 2013 to February 2018, 411,216 donations were tested for HBsAg, anti‐HCV, anti‐HIV/HIV antigen, and antibodies to Treponema pallidum. HBV, HCV, and HIV nucleic acid testing (NAT) was performed in mini‐pools of six or in individual donations (IDs). Reactive donations were evaluated further with alternative serological assays and ID‐NAT re‐testing. A follow‐up procedure was developed to evaluate a subset of deferred donors that were either potential NAT yield cases, serology non‐reactive and NAT non‐repeated reactive (NRR), or serology NRR irrespective of NAT result. RESULTS Serological and molecular routine, plus supplemental testing, identified HBV, HCV, HIV, and TP in 503 (0.12%), 392 (0.09%), 156 (0.04%), and 2041 (0.49%) donations, respectively. Overall, 683 of 4156 (16.4%) eligible donors and 205 donors deferred prior 2013 participated in the program. They included 664 serology NRR and 224 NAT yield cases, and 58.8% repeat donors. All markers combined, follow‐up documented false reactivity, primary acute infections, and OBI in 61.9% (550/888), 3.3% (29/888), and 12.8% (114/888) of these donors, respectively. Isolated anti‐HBc or anti‐HBs reactivity was observed in 22% of cases. CONCLUSION Follow‐up testing refined infection status in 78.0% (693/888) of deferred donors with unconfirmed screening results. This high false‐positive rate encouraged to reevaluate the current screening strategies and to consider donor reentry.

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Use of supplemental anti‐HBc testing of donors showing non‐discriminating reactive results in multiplex nucleic acid testing

Cited by 8 publications

References 12 publications

Nearly half of Ultrio plus NAT non-discriminated reactive blood donors were identified as occult HBV infection in South China

Nearly half of Ultrio plus NAT non-discriminated reactive blood donors were identified as occult HBV infection in South China

False positive viral marker results in blood donors and their unintended consequences

Follow‐up program for blood donors with unconfirmed screening results reveals a high false‐positive rate in Dalian, China

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