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

Elsevier

Available online 14 April 2023, 105446

Journal of Clinical VirologyAuthor links open overlay panel, , , , , , ABSTRACTBackground

Diagnosis of Human T-cell Lymphotropic Virus (HTLV) types I and II infection requires sequencial testing with firstly a screening using an Enzyme immunoassay followed by a confirmatory test.

Objectives

To compare the performances of the Alinity i rHTLV-I/II (Abbott®) and LIAISON® XL murex recHTLV-I/II serological screening tests to the ARCHITECT rHTLVI/II test followed if positive by HTLV BLOT 2.4, MP Diagnostics as the reference.

Study design

119 serum samples from 92 known HTLV-I infected patients and 184 from uninfected patients with HTLV were analyzed in parallel with, Alinity i rHTLV-I/II, LIAISON® XL murex recHTLV-I/II and ARCHITECT rHTLVI/II.

Results

Alinity i rHTLV-I/II and Liaison XL murex recHTLV-I/II exhibited a total agreement with ARCHITECT rHTLVI/II for both positive and negative samples. Both tests are suitable alternatives for HTLV screening.

Section snippetsBackground

Human T lymphotropic virus type I (HTLV-I) and Human T lymphotropic virus type II (HTLV-II) were the first retroviruses discovered, respectively in 1980 [1] and 1982 [2]. They are responsible for adult T-cell leukemia/lymphoma (ATLL) [3], HTLV-associated myelopathy (HAM) [4] and inflammatory diseases such as uveitis, myositis and dermatitis [4]. HTLV in adult population is unevenly distributed worldwide: highly endemic in Japan, Caraibeans and several African areas while virtually absent in

Objectives

The objective of this study was to compare two screening immunoassays, Alinity i rHTLV-I/II (Abbott®, Rungis, France), LIAISON® XL murex recHTLV-I/II (DiaSorin, Antony, France), with ARCHITECT rHTLV-I/II (Abbott, Rungis, France) followed for positive samples by HTLV BLOT 2.4 (MP Diagnostics™, Illkirch-Graffenstaden, France) as the reference.

Samples

The study included a retrospective part of clinical and analytical sensitivity, and an exploratory prospective part of specificity. All serum samples had been tested following the routine algorithm of the Service of Virology at the Pitié Salpêtrière Hospital (Paris, France). Architect rHTLV-I/II was used as the screening method with HTLV BLOT 2.4 as the confirmatory assay for reactive results. Only samples confirmed HTLV positive were included in the retrospective study. For clinical

Results

With ARCHITECT rHTLVI/II followed for reactive sera by HTLV BLOT 2.4, MP Diagnostics as the reference assay, Alinity i rHTLV-I/II and LIAISON® XL murex recHTLV-I/II identified correctly all 119 positive samples leading to a sensitivity of 100% with a 95% CI [97%-100%]. All S/CO ranges were similar for the three methods, but Alinity i rHTLV-I/II had a mean S/CO value lower in comparison with Architect (p = 7.5E-16) and Liaison (p = 1.2E-11) (Table 1). Mean S/CO value for reactive samples was

Discussion

All 119 samples from HTLV-I-infected patients were tested positive with the two studied methods, although S/CO values were moderately correlated. A phenomenon of saturation of the signal was observed with LIAISON® XL murex recHTLV-I/II above 130 S/CO, and positive ratios were lower using Alinity i rHTLV-I/II. Of note, all 184 uninfected patients were non-reactive with the two methods. Positive and negative results were highly discriminated, especially for LIAISON® XL murex recHTLV-I/II with a δ

Conclusion

On a serum panel of 119 infected and 184 uninfected patients with HTLV-I/II, Alinity i rHTLV-I/II and LIAISON® XL murex recHTLV-I/II exhibited a total agreement compared with Architect rHTLV-I/II as the referent assay. These two tests are therefore suitable for the screening of HTLV-I/II infection in donors, subject at risk and patients with ATLL or HAM.

Author contributions

Vincent Guiraud: preparation, submission of the final manuscript, Florian Crémoux: and analyzes of data, Isabelle Leroy: samples testing, Julien Cohier samples testing. Pierre Hernandez samples testing. Safietou Mansaly samples testing

Fundings

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

CRediT authorship contribution statement

Vincent Guiraud: Data curation, Writing – original draft. Florian Crémoux: Supervision, Funding acquisition, Validation. Isabelle Leroy: Visualization. Julien Cohier: . Pierre Hernandez: . Safietou Mansaly: . Agnès Gautheret-Dejean: Conceptualization, Methodology, Writing – review & editing.

Declaration of Competing Interests

The authors declare that they have no competing financial interests or personal relationships that could have influenced the work reported in this paper.

Acknowledgments

The authors thank ADEBIOPHARM ER28 association for the financial participation to this study. The authors thank Abbott and DiaSorin laboratories for providing free kits for this study. Otherwise, they had no part on study design, data collection, data analyses and interpretation, manuscript writing nor submission to publication. The authors thank Mostafa Habib for his assistance.

Ethics

This study complies with Good Clinical Practices and ethical principles of the Helsinki declaration. All data were anonymized before analysis. Patients were systematically notified of any supplementary biological analyses on frozen samples, initially collected as part of routine clinical practice.

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