Evaluation of the Procleix Ultrio Elite Assay and the Panther-System for Individual NAT Screening of Blood, Hematopoietic Stem Cell, Tissue and Organ Donors

Heim, Albert

doi:10.1159/000446217

Cited by 7 publications

(5 citation statements)

References 16 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Alternative nucleic acid amplification technologies recently introduced for HBV include real-time transcription-mediated amplification (TMA). (11) Due to its excellent sensitivity, TMA has an established track record in the context of blood safety (12) and is applied to the quantification of human immunodeficiency virus RNA (13) and hepatitis C virus RNA. (14) The TMA assay incorporates two enzymes for nucleic acid amplification: Moloney murine leukemia virus reverse transcriptase and T7 RNA polymerase.…”

Section: See Editorial On Page 949mentioning

confidence: 99%

HBV‐RNA Co‐amplification May Influence HBV DNA Viral Load Determination

Maasoumy

Geretti

Frontzek³

et al. 2020

Hepatol Commun

View full text Add to dashboard Cite

Despite effective hepatitis B virus (HBV)-DNA suppression, HBV RNA can circulate in patients receiving nucleoside/ nucleotide analogues (NAs). Current assays quantify HBV DNA by either real-time polymerase chain reaction (PCR), which uses DNA polymerase, or transcription-mediated amplification, which uses reverse-transcriptase (RT) and RNA polymerase. We assessed the effect of RT capability on HBV-DNA quantification in samples from three cohorts, including patients with quantified HBV RNA. We compared the HBV-DNA levels by real-time PCR (cobas HBV, Roche 6800/8800; Xpert HBV, Cepheid), transcription-mediated amplification (Aptima HBV, Hologic), and real-time PCR with added RT capability (cobas HBV+RT). In the first cohort (n = 45) followed over 192 weeks of NA therapy, on-treatment HBV-DNA levels were higher with cobas HBV+RT than cobas HBV (mean difference: 0.14 log 10 IU/ mL). In a second cohort (n = 50) followed over 96 weeks of NA therapy, HBV-DNA viral load was significantly higher with the cobas HBV+RT and Aptima HBV compared with the cobas HBV test at all time points after initiation of NA therapy (mean difference: 0.65-1.16 log 10 IU/mL). A clinically significant difference was not detected between the assays at baseline. In a third cohort (n = 53), after a median of 2.2 years of NA therapy, we detected HBV RNA (median 5.6 log 10 copies/mL) in 23 patients (43.4%). Median HBV-DNA levels by Aptima HBV were 2.4 versus less than 1 log 10 IU/mL in samples with HBV RNA and without HBV RNA, respectively (P = 0.0006). In treated patients with HBV RNA, Aptima HBV measured higher HBV-DNA levels than Xpert HBV and cobas HBV. Conclusion:Tests including an RT step may overestimate HBV DNA, particularly in samples with low viral loads as a result of NA therapy. This overestimation is likely due to amplification of HBV RNA and may have an impact on clinical decisions. (Hepatology Communications 2020;4:983-997).

show abstract

Section: See Editorial On Page 949mentioning

confidence: 99%

HBV‐RNA Co‐amplification May Influence HBV DNA Viral Load Determination

Maasoumy

Geretti

Frontzek³

et al. 2020

Hepatol Commun

View full text Add to dashboard Cite

show abstract

“…All 15 SANBS anti‐HIV yield samples were detected by the Architect, and in addition one of these samples was reactive with the Panther system as well. This could mean that this sample had HIV‐2 virus RNA and not HIV‐1 virus RNA as the Ultrio Plus assay is designed to detect HIV‐1 RNA only while Ultrio Elite is designed to detect both HIV‐1 and HIV‐2 RNA , we could not confirm this though. Although infection with HIV‐2 occurs mainly in West Africa, the incidence of HIV‐2 infections may increase in the rest of the world including Southern Africa due to increasing immigration from Western African countries where HIV‐2 is endemic .…”

Section: Discussionmentioning

confidence: 93%

“…Assay systems were compared based on cost and sustainability, assay type and technology, sensitivity and specificity, ease of use and the size of the instrument versus available laboratory space. The sensitivity of the Ultrio Elite assay which is run on the Panther blood screening system is comparable to the Ultrio Plus assay apart from the addition of oligonucleotides for human immunodeficiency virus type 2 (HIV‐2) detection and the Ultrio Plus and the Cobas s201 Taqscreen MPX are reported to be of equal sensitivity , we therefore assumed no significant differences on the performance of the Ultrio Elite and the Cobas s201 Taqscreen MPX. The cost of the Panther system was 0·2% higher than that of the Cobas s201 Taqscreen MPX; however, the size of the Cobas s201 Taqscreen MPX was too high to fit into our laboratory space compared to the Panther instruments as we needed two instruments to include a back‐up.…”

Section: Introductionmentioning

confidence: 99%

The validation and implementation of donor screening for hepatitis B virus, hepatitis C virus, human immunodeficiency virus 1/2 and syphilis by ultrio elite assay (Panther system) and chemiluminescence assay (Abbott Architect i2000SR system) in Namibia

Chipare

Charuma

Finckenstein

et al. 2017

ISBT Science Series

View full text Add to dashboard Cite

Infectious disease screening of Namibia blood donations for infectious diseases was contracted to the South African National Blood Service (SANBS) since 2004 and needed to be relocated back to Namibia. A cost analysis conducted showed that by introducing certain strategies, it was cost-effective to implement ID-NAT in Namibia. NAMBTS chose Ultrio Elite assay/Panther System (Gen-Probe and Novartis, USA) for ID-NAT for HIV 1/2 RNA, HBV DNA and HCV RNA and Chemiluminescent immunoassay done on the Architect i2000SR system (Abbott, Delkenheim, Germany) for HIV 1/2 Ag/Ab, anti-HCV, HBsAg and Syphilis. For performance evaluation, the Panther System was compared with the Procleix TIGRIS system-Ultrio Plus assay (Gen-Probe and Novartis, USA) while the Architect system was compared with the Abbott PRISM. The results of this evaluation demonstrated a 100% sensitivity and 100% specificity of the Ultrio Elite assay while the Architect also demonstrated 100% sensitivity and specificity of above 99% for detecting viral markers for HBV, HIV and HCV, and 97% sensitivity and 99Á7% specificity for detecting syphilis. We found both the Procleix Panther and Architect systems to be flexible, robust and effective in screening blood for transfusion in our setting. Donor screening for HIV 1/2, HBV, HCV and syphilis for ID-NAT and serology using the Procleix Panther and Architect systems was successfully relocated from South Africa and implemented in February 2014 in Namibia.

show abstract

“…High proportion of anti-HBc was observed in OBI cases (402/442, 90.95%), which is consistent with findings from previous studies [ 12 , 23 ]. Studies report that anti-HBc is an important indicator for serological status of HBV infection to exclude false positive results in NAT, mainly in non-repeated positive donors [ 12 , 24 , 25 ].…”

Section: Discussionmentioning

confidence: 99%

Characteristic of HBV nucleic acid amplification testing yields from blood donors in China

Wang

Feng

et al. 2021

BMC Infect Dis

View full text Add to dashboard Cite

Background Nucleic acid amplification testing (NAT) for blood screening has been previously performed in some countries to determine NAT yields. The current study sought to explore the non-discriminating reactive NAT yields using individual-NAT (ID-NAT) and characteristics of HBV NAT yields through a 10-year retrospective analysis in Zhejiang, China. Methods Blood donations were analyzed using individual-NAT mode by the transcription-mediated amplification (TMA) method. Supplementary HBV serological tests were performed using chemiluminescent immunoassay, and HBV viral load assay was performed by real-time polymerase chain reaction. Follow-up studies were performed in partial donors with low HBV viral loads. Results Non-discriminating reactive NAT yields and HBV NAT yields varied in different years. The yields ranged from 853.73 per million to 2018.68 per million and 624.60 per million to 1669.50 per million, respectively. In the 476 NAT yields, 19 were probable window periods (WP), 33 probable occult hepatitis B virus infections (OBIs), 409 were confirmed OBIs and 15 were chronic HBV infections. ID-NAT results were categorized in four groups, and the findings showed that the levels of HBV DNA viral loads were different in the four different groups (χ2 = 275.02, p < 0.01). HBV viral load distribution was significantly different between anti-HBs positive and anti-HBc positive samples (χ2 = 49.429, p < 0.01). Notably, only 42.03% donors were NAT repeated positive in the 138 repeat donors’ follow up tests. Conclusion NAT screening of blood donations can reduce the risk of transfusion-transmitted HBV infections. Positive proportions of anti-HBs and anti-HBc are correlated with the HBV viral load level. However, low level of viral load donors pose risks in HBV NAT assays, and show fluctuating state for HBV viral load and leads to non-repeated NAT results during follow up studies.

show abstract

Evaluation of the Procleix Ultrio Elite Assay and the Panther-System for Individual NAT Screening of Blood, Hematopoietic Stem Cell, Tissue and Organ Donors

Cited by 7 publications

References 16 publications

HBV‐RNA Co‐amplification May Influence HBV DNA Viral Load Determination

HBV‐RNA Co‐amplification May Influence HBV DNA Viral Load Determination

The validation and implementation of donor screening for hepatitis B virus, hepatitis C virus, human immunodeficiency virus 1/2 and syphilis by ultrio elite assay (Panther system) and chemiluminescence assay (Abbott Architect i2000SR system) in Namibia

Characteristic of HBV nucleic acid amplification testing yields from blood donors in China

Contact Info

Product

Resources

About