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2015, Number 2

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Rev Cubana Med Trop 2015; 67 (2)

Evaluation of the performance of the immunoenzymatic diagnostic system DAVIH-HTLV-I for detection of antibodies against the human T-cell lymphotropic virus type 1 (HTLV-I)

Romero MK, Pérez GMT, Hernández AM, Sánchez DE, Martín AD

Language: Spanish
References: 17
Page: 173-182
PDF size: 96.62 Kb.


ABSTRACT

Introduction: The human T-cell lymphotropic virus type 1 (HTLV-I) is the causal agent of adult T-cell leukemia/lymphoma (ATLL). Screening for HTLV-I in our country has revealed its unquestionable presence in the population. DAVIH-HTLV-I is a micro-ELISA system produced by DAVIH Laboratories for detection of antibodies against HTLV-I in human serum or plasma.
Objective: Evaluate the performance of the DAVIH-HTLV-I system with a view to registration in the Registry of Diagnostic Media Products of the Center for State Control of the Quality of Drugs (CECMED), an indispensable requirement for its use in our country.
Methods: Four sample panels were used to study the following variables: specificity, sensitivity, efficacy, concordance with the reference system Vironostika HTLV-I/II (Biomeriéux), accuracy on two levels: repeatability (intra-assay) and intermediate accuracy (inter-assay), and robustness.
Results: The following results were obtained: specificity 99.84%; sensitivity 96.49%; concordance 96.55%; detection limit for a 1/256 dilution; high intra- and inter-assay accuracy (CV below 15% and 20%, respectively); a robust system when faced with temperature changes between 36°C and 38°C.
Conclusions: Results show that the DAVIH-HTLV-I system may be used for the screening of antibodies against HTLV-I in the Cuban population. It was therefore recommended for registration with CECMED.


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