A new parallelism acceptance criterion for validating large plate bioassay results

Story, Michael J.; Winson, Julie A.; Beyer, Preston L.; Boehm, Garth

doi:10.1016/0092-1157(86)90010-7

Journal of Biological Standardization

1986

DOI: 10.1016/0092-1157(86)90010-7

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A new parallelism acceptance criterion for validating large plate bioassay results

Michael J. Story¹,

Julie A. Winson²,

Preston L. Beyer³

et al.

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“…As assay methodology, technique, and precision improve, this will be reflected in a descriptive standard reference curve with much less variability. In this situation, standard ANOVA techniques will more frequently detect nonparallelism in near parallel lines (20).…”

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confidence: 99%

“…These weaknesses in the ANOVA methodology have led many researchers to discard it as a reliable measure for ascertaining departures from parallelism. Story et al (20) adjusted the ANOVA calculations to reflect a more realistic interpretation of parallelism in assays that display high degrees of precision. Other investigators have used alternate nonparametric techniques, including subjective visual evaluations, for this purpose.…”

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Determination of parallelism and nonparallelism in bioassay dilution curves

et al. 1994

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There is a lack of consensus among investigators who use a variety of immunoassay techniques (e.g., enzyme-linked immunosorbent assay [ELISA] and radioimmunoassay) regarding the protocols for describing and forming standard reference or calibration curves and interpolating serum antibody concentrations. This confounds the issue of detecting the presence or absence of parallelism between standard reference serum and serially diluted serum sample curves. These curves must be parallel to support the assumption that the antibody-binding characteristics are similar enough to allow the determination of antibody levels in the diluted serum sample. There is no universal and widely adopted strategy for assessing parallelism in bioassays, and without an assurance of parallelism, investigators are not able to calculate reliable estimates for antibody concentrations in serum samples. Furthermore, single-point (dilution) serum assays do not provide information related to parallelism and nonparallelism, and this, too, may lead to considerable error when calculating antibody concentrations. When assay methodology, technique, and precision improve to the extent that standard reference serum and serially diluted serum sample curves are fit with little error, standard analysis of variance techniques are overly sensitive to negligible departures from parallelism. We present a series of guidelines that compose a protocol for assessing parallelism between bioassay dilution curves that are applicable to data derived from ELISAs. These criteria should be applicable, with minor modifications, to most immunoassay experimental situations and, most importantly, are not dependent on the mathematical model used to form the standard reference curve. These guidelines have evolved in our laboratories over the past 4 years during the performance of thousands of ELISAs for antibodies to the capsular polysaccharides of Neisseria meningitidis groups A and C and Haemophilus influenzae type b.

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Determination of parallelism and nonparallelism in bioassay dilution curves

et al. 1994

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Statistical considerations for vaccine immunogenicity trials

Plikaytis

Carlone

2005

Vaccine

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A new parallelism acceptance criterion for validating large plate bioassay results

Cited by 2 publications

References 0 publications

Determination of parallelism and nonparallelism in bioassay dilution curves

Determination of parallelism and nonparallelism in bioassay dilution curves

Statistical considerations for vaccine immunogenicity trials

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