Resumen

OCHOA, Rolando et al. Validation of an ELISA for the quantitative determination of tetanus antitoxin in human serum. Vaccimonitor [online]. 2000, vol.9, n.4, pp. 16-21. ISSN 1025-0298.

An indirect solid-phase enzyme-linked immunosorbent assay (ELISA) was developed for the quantitation of tetanus antitoxin in human serum on the basis of a previously calibrated standard. Intra and inter-assay imprecision ranged around 10%. This assay showed an excellent accuracy with recovery values between 90% and 110%. Parallelism deviations were below 10%. They were evaluated by dilutions that covered the working range of the standard curve. The detection limit was 0.0016 International Units per mL (IU/mL). A good correlation was found between the ELISA and the neutralization test (R2= 0,9862). The fitting linear equation was: ELISA = 0,993; neutralization test - 0,2143. Tetanus antitoxin was quantified in serum samples from 408 children, 1-5 year-olds, randomly selected in Havana City. Each age was separately analyzed. The maximum response was reached at 2 years, after finishing the basic scheme of immunization. All children showed antitoxin values higher than the minimum protective level (0,01 IU/mL).

Palabras clave : tetanus antitoxin; enzyme immunoassay; ELISA; validation.

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