Comparison of two new HTLV-I/II screening methods, Abbott Alinity i rHTLV-I/II and Diasorin LIAISON® XL murex recHTLV-I/II, to Abbott architect rHTLVI/II assay

Guiraud, Vincent; Crémoux, Florian; Leroy, Isabelle; Cohier, Julien; Hernandez, Pierre; Mansaly, Safietou; Gautheret-Dejean, Agnès

doi:10.1016/j.jcv.2023.105446

Cited by 7 publications

(3 citation statements)

References 19 publications

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“…Regarding the comparison of the assays evaluated, when we categorized them into low, intermediate and high RLU ( Figure 2a ) according to the CLIA sensitivity cut-off point, it was identified that the low and intermediate zones were negative in the WB and the FC-Simplex. The CLIA’s very low cut-off point is a good factor for using this methodology as a screening test, as has been observed in other studies carried out to verify the application of this assay during screening [30–32,36]. However, false-positive results in immunological assays need to be evaluated and minimized, as this impacts the quality of life of candidates for blood donations with a positive result during screening tests.…”

Section: Discussionmentioning

confidence: 98%

“…Conducting research with other populations would provide complementary data and give a better overview of the prevalence of the HTLV virus in Amazonas. If new surveys are carried out on blood donors, it would be interesting to use the same assay methodologies as in the present study, with the aim of providing a safer comparison, taking into account that ELISA and CLIA may differ in terms of the screening and diagnosis process [30,35,36].…”

Section: Discussionmentioning

confidence: 99%

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Performance of Immunological Assays for Universal and Differential Diagnosis of HTLV-1/2 Infection in Candidates for Blood Donations from the Brazilian Amazon

Santos,

Catão,

Martins

et al. 2024

Preprint

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The present study compares the ability of distinct immunological assays (chemiluminescence immunoassay-CLIA, western blot-WB and flow cytometry-FC-Simplex and Duplex) to detect anti-HTLV antibodies in candidates for blood donations at the Amazonas State Blood Center (Brazil) between January 2018 and December 2022. Overall, 257,942 samples from candidates for blood donations were screened using CLIA, which led to 0.15% seropositivity for HTLV (409 samples). A total of 151 candidates for blood donations were enrolled for retesting with CLIA followed by additional testing using WB and FC-Simplex and Duplex analysis. Our results demonstrated that 62% (93/151), 20% (30/151) and 17% (26/151) of the samples presented positive results with retesting using CLIA, WB and FC-Simplex analysis, respectively. Additional analysis of the CLIA, WB and FC-Simplex results revealed an overall agreement of 56% for CLIA and WB (22 co-negative; 30 co-positive samples), 48% for CLIA and FC-Simplex (21 co-negative; 24 co-positive samples) and 80% for WB and FC-Simplex (51 co-negative; 23 co-positive samples). Considering the WB as the reference standard for the diagnosis of infection with HTLV-1/2, we observed that the CLIA results of ≤3.0 RLU and >10.0 RLU in the retest can be used define a negative or positive result, respectively, and could be used as new specific cut-off values. The overall agreement between WB and FC-Duplex for accomplishing the differential diagnosis was evaluated and demonstrated 100% correspondence for the diagnosis of HTLV-1 (15/15) and HTLV-2 (7/7). Our findings demonstrate that gaps in the diagnosis of infection with HTLV-1/2 could be overcome by the simultaneous use of distinct immunological assays during retesting of candidates for blood donations.

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Section: Discussionmentioning

confidence: 98%

Section: Discussionmentioning

confidence: 99%

Performance of Immunological Assays for Universal and Differential Diagnosis of HTLV-1/2 Infection in Candidates for Blood Donations from the Brazilian Amazon

Santos,

Catão,

Martins

et al. 2024

Preprint

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“…The Elecsys HTLV-I/II assay showed 100% sensitivity and 99.91% specificity to the Architect rHTLV-I/II assay and 98.63% specificity and 99.95% specificity to the Ortho Avioq HTLV-I/II assay using a large-scale collection of samples from Europe and Japan ( 13 ). In addition, both the Abbott Alinity i rHTLV-I/II and DiaSorin Liaison XL murex recHTLV-I/II tests showed 100% sensitivity and 100% specificity to the Architect rHTLV-I/II assay ( 25 ).…”

Section: Discussionmentioning

confidence: 99%

Performance evaluation of Espline HTLV-I/II, a newly developed rapid immunochromatographic antibody test for different diagnostic situations

Kuramitsu,

Momose,

Uchida

et al. 2023

Microbiol Spectr

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Antibody screening tests for human T-cell leukemia virus type 1 (HTLV-1) are performed based on methods such as chemiluminescent enzyme immunoassay (CLEIA), chemiluminescence immunoassay (CLIA), electrochemiluminescence immunoassay, and particle agglutination (PA). Espline HTLV-I/II, a commercially available, easy-to-use, and rapid immunochromatographic antibody test (IC), was developed for situations where expensive instruments and laboratory equipment are not available. In this report, we compared the performance of IC with the above existing tests using diverse samples derived from asymptomatic HTLV-1 carriers and patients with HTLV-1-associated diseases in collaboration with 11 Japanese institutes. We found that IC detected HTLV-1 infection in all samples from HTLV-1-associated diseases, including adult T-cell leukemia, HTLV-1-associated myelopathy, and HTLV-1 uveitis (200/200). The sensitivity of IC compared with CLIA, CLEIA, and PA was 99.2% (363/366), 100% (241/241), and 100% (47/47), respectively, and the specificity was 99.4% (994/1000), 100% (60/60), and 100% (40/40), respectively. The positive and negative predictive values of IC were 99.7% [95% confidence interval (CI): 99.12–99.92] and 99.5% (95% CI: 98.82–99.75), respectively. However, IC had difficulty in correctly judging samples that were diagnosed as seroreactive in other first screening tests but negative by a confirmatory test; for example, of 612 confirmed negative samples that were CLIA seroreactive, 332 samples were IC positive. These results confirmed that IC has sufficient sensitivity and specificity as a screening test for HTLV-1, although, like the other screening tests, it also requires a confirmatory test to determine HTLV-1 infection correctly. IMPORTANCE The World Health Organization estimated that 5–10 million people are infected with human T-cell leukemia virus type 1 (HTLV-1). This number is likely to be underestimated because reliable endemic data are available for only approximately 1.5 billion people worldwide. The point-of-care test is a powerful tool for the easy and quick detection of infections without the requirement for expensive instruments and laboratory equipment. Espline HTLV-I/II, a newly developed rapid immunochromatographic antibody test that was evaluated in this study, might significantly advance our understanding of the global epidemiology of HTLV-1 infection.

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Human T‐Cell Lymphotropic Virus Types 1 and 2

Gillim,

Grover

2024

Manual of Molecular and Clinical Laboratory Immunology

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Comparison of two new HTLV-I/II screening methods, Abbott Alinity i rHTLV-I/II and Diasorin LIAISON® XL murex recHTLV-I/II, to Abbott architect rHTLVI/II assay

Cited by 7 publications

References 19 publications

Performance of Immunological Assays for Universal and Differential Diagnosis of HTLV-1/2 Infection in Candidates for Blood Donations from the Brazilian Amazon

Performance of Immunological Assays for Universal and Differential Diagnosis of HTLV-1/2 Infection in Candidates for Blood Donations from the Brazilian Amazon

Performance evaluation of Espline HTLV-I/II, a newly developed rapid immunochromatographic antibody test for different diagnostic situations

Human T‐Cell Lymphotropic Virus Types 1 and 2

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