Evaluation of a new third-generation ARCHITECT rHTLV-I/II assay for blood screening and diagnosis

Kapprell, Hans-Peter; Stieler, Myriam; Oer, Michael; Goller, Andreas; Hausmann, Michael; Schochetman, Gerald; Devare, Sushil G.; Qiu, Xiaoxing

doi:10.1016/j.diagmicrobio.2009.12.021

Cited by 12 publications

(19 citation statements)

References 43 publications

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“…These findings are consistent with previously reported results. In an earlier study of 406 precharacterized HTLV-1/2-positive samples, Abbott Architect rHTLV-I/II had a sensitivity of 100% (21, 22). Similarly, in a study of 714 confirmed HTLV-1/2-positive samples, a sensitivity of 100% was reported for Abbott Prism HTLV-I/HTLV-II (23).…”

Section: Discussionmentioning

confidence: 93%

“…The results for the comparator assays were consistent with previous data. In a study of 5,646 blood donor samples, Abbott Architect rHTLV-I/II had a specificity of 99.95%, compared with 99.86% when tested in 692 routine diagnostic samples (21, 22). Ortho Avioq HTLV-I/II had a specificity of 99.95% in a study of 11,415 blood donor samples (24), while Abbott Prism HTLV-I/HTLV-II had a specificity of 99.93% in a study of 21,943 blood donor samples (23).…”

Section: Discussionmentioning

confidence: 99%

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Evaluation of Sensitivity and Specificity Performance of Elecsys HTLV-I/II Assay in a Multicenter Study in Europe and Japan

et al. 2017

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Screening of blood for human T-cell lymphotropic virus type 1 and type 2 (HTLV-1 and -2, respectively) is important to diagnose and prevent infection and ensure the safety of blood supplies. The Elecsys HTLV-I/II assay is a newly developed, electrochemiluminescence screening assay for the detection of HTLV-1/2 infection. The sensitivity and specificity of the Elecsys HTLV-I/II assay were determined using well-characterized HTLV-1/2-positive serum and plasma samples and routine diagnostic and blood donor samples expected to be HTLV negative, respectively. These results were compared with those for at least one of the following CE-marked assays at seven independent laboratories and the Roche Diagnostics facility in Penzberg, Germany: Abbott Architect rHTLV-I/II, Ortho Avioq HTLV-I/II Microelisa system, Abbott Prism HTLV-I/HTLV-II, and DiaSorin Murex HTLV I+II. Fujirebio INNO-LIA HTLV-I/II Score was used as a confirmatory assay. The Elecsys HTLV-I/II, Abbott Architect rHTLV-I/II, and Abbott Prism HTLV-I/HTLV-II assays detected all HTLV-1/2-positive samples (sensitivity, 100%). Sensitivity for Ortho Avioq HTLV-I/II was 98.63%. The Elecsys HTLV-I/II assay had a specificity of 99.95% in blood donor samples, which was comparable to results for the other assays (range, 99.91 to 100%). In routine diagnostic samples, the specificity of the Elecsys HTLV-I/II assay was 99.83%, compared with 99.70% for Abbott Architect rHTLV-I/II. Specificity for the Elecsys HTLV-I/II assay in potentially cross-reactive samples was 100%, compared with 99.0% for Ortho Avioq HTLV-I/II and 99.2% for DiaSorin Murex HTLV I+II. The Elecsys HTLV-I/II assay has the sensitivity and specificity to support its use as a routine screening assay for detecting HTLV infection.

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Section: Discussionmentioning

confidence: 93%

Section: Discussionmentioning

confidence: 99%

Evaluation of Sensitivity and Specificity Performance of Elecsys HTLV-I/II Assay in a Multicenter Study in Europe and Japan

et al. 2017

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“…From the third generation, the recombinant proteins and synthetic peptides were used to capture antibodies by double-antigen sandwich method. 11 These technological advances have demonstrated that the previous comparative assessments showed higher sensitivity and specificity with the third generation than with the first and second generation. [12][13][14] F I G U R E 1 Comparison of the two anti-HTLV assays, Elecsys HTLV-I/II and ARCHITECT rHTLV-I/II, with proven anti-HTLV-positive specimens (n = 100) F I G U R E 2 Frequency histogram for the S/CO results obtained from the potential blood donor screening (n = 500).…”

Section: Discussionmentioning

confidence: 99%

“…For the first‐ and second‐generation assays, an indirect format was applied using viral lysate as an antigen. From the third generation, the recombinant proteins and synthetic peptides were used to capture antibodies by double‐antigen sandwich method . These technological advances have demonstrated that the previous comparative assessments showed higher sensitivity and specificity with the third generation than with the first and second generation …”

Section: Discussionmentioning

confidence: 99%

Evaluation of Elecsys HTLV‐I/II assay in comparison with ARCHITECT rHTLV‐I/II assay with Korean samples

Yun

Kim

Sohn³

et al. 2019

Clinical Laboratory Analysis

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BackgroundThe seroprevalence rate of human T‐lymphotropic virus I and II (HTLV‐I/II) in Korean blood donors has been known as 0.004%, and HTLV‐I/II Ab screening test has been performed since 2008 in Korea. Korea Ministry of Food and Drug Safety (MFDS) approved two chemiluminescent microparticle immunoassays (CMIA) for testing HTLV‐I/II antibody, ABBOTT PRISM HTLV‐I/HTLV‐II and ARCHITECT rHTLV‐I/II. A multicenter performance evaluation study in Europe and Japan was carried out with the new electrochemiluminescence immunoassay (ECLIA) for HTLV‐I/II antibody detection, Elecsys HTLV‐I/II assay which launched in 2017, but not in Korea. We aimed to evaluate the clinical performance of Elecsys HTLV‐I/II assay in comparison with ARCHITECT rHTLV‐I/II for the detection of HTLV‐I/II antibody with Korean samples.MethodsFor sensitivity evaluation, 100 HTLV‐I/II‐positive Korean standards from Korean Red Cross and two HTLV‐II‐positive samples that were purchased from Seracure were used. For the specificity, 500 potential donor specimens from Korea University Hospital healthcare center were used. All the samples were simultaneously analyzed by the two HTLV‐I/II assays, Elecsys HTLV‐I/II assay and ARCHITECT rHTLV‐I/II assay.ResultsElecsys HTLV‐I/II assay and ARCHITECT rHTLV‐I/II assay showed a complete agrement. Elecsys HTLV‐I/II assay showed 100% sensitivity (95% CI: 96.38‐100.0) and specificity (95% CI: 99.26‐100.0).ConclusionsElecsys HTLV‐I/II assay is as reliable as ARCHITECT rTHLV‐I/II assay, and can be used as a screening test for HTLV‐I/II in Korea.

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“…Recently, a variety of sensitive diagnostic kits for serological assays have become available to detect both HTLV-1 and HTLV-2 infections. [9][10][11] However, because pathogenesis between HTLV-1 and HTLV-2 are largely different, discrimination is important when specimens show positivity in these tests. Western blotting is often used to confirm the infection, but indeterminate results occur frequently.…”

Section: Introductionmentioning

confidence: 99%

Development and evaluation of human T‐cell leukemia virus‐1 and ‐2 multiplex quantitative PCR

Kuramitsu

Okuma

Tezuka

et al. 2019

Microbiology and Immunology

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The diagnosis of human T ‐cell leukemia virus type 1 (HTLV‐1) infection in Japan is usually performed by serological testing, but the high rate of indeterminate results from western blotting makes it difficult to assess the infection accurately. Nucleic acid tests for HTLV‐1 and/or HTLV‐2 are used to confirm infection with HTLV‐1 and/or HTLV‐2 and are also used for the follow‐up of HTLV‐1 related diseases. To prepare a highly sensitive method that can discern infection with HTLV‐1 and HTLV‐2, a multiplex quantitative polymerase chain reaction (qPCR) by large‐scale primer screening was developed. Sensitivity and specificity were evaluated by serial dilution of cell lines and by testing with known clinical samples. The resulting multiplex qPCR can detect about four copies of HTLV‐1 provirus per 105 cells. Moreover, HTLV‐1 provirus could be detected in 97.2% (205 of 211) of HTLV‐1 seropositive clinical samples. These sensitivities were sufficiently high compared with the methods reported previously. Also, all the HTLV‐2 seropositive clinical samples tested were found to be positive by this method (three of three). In conclusion, this method can successfully and simultaneously detect both types of HTLV‐1 and HTLV‐2 provirus with extremely high sensitivity.

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Evaluation of a new third-generation ARCHITECT rHTLV-I/II assay for blood screening and diagnosis

Cited by 12 publications

References 43 publications

Evaluation of Sensitivity and Specificity Performance of Elecsys HTLV-I/II Assay in a Multicenter Study in Europe and Japan

Evaluation of Sensitivity and Specificity Performance of Elecsys HTLV-I/II Assay in a Multicenter Study in Europe and Japan

Evaluation of Elecsys HTLV‐I/II assay in comparison with ARCHITECT rHTLV‐I/II assay with Korean samples

Development and evaluation of human T‐cell leukemia virus‐1 and ‐2 multiplex quantitative PCR

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