Interlaboratory agreement among results of human papillomavirus type 16 enzyme-linked immunosorbent assays

Howard Strickler, Allan Hildesheim, Raphael P. Viscidi, Keerti V. Shah, Brad Goebel, James Drummond, David Waters, Yeping Sun, Nancy L. Hubbert, Sholom Wacholder, Louise A. Brinton, Cheng Long Han, Philip C. Nasca, Roberta McClimens, Karen Turk, Violet Devairakkam, Susan Leitman, Cynthia Martin, John T. Schiller

Research output: Contribution to journalArticle

25 Citations (Scopus)

Abstract

Serological assays for measuring antibodies to human papillomavirus type 16 (HPV-16) virus-like particles (VLPs) have become important epidemiologic tools in recent years. However, the interlaboratory replicability of these assays has not been assessed. In this investigation, three laboratories tested a panel of specimens obtained from two different groups: 265 subjects in a vulvar cancer case-control study and 107 healthy volunteer blood donors. Each laboratory used an enzyme-linked immunosorbent assay (ELISA), but no attempt was made to standardize assay procedures among the three laboratories. The data showed good day-to-day intralaboratory replicability in laboratory 1 (correlation coefficient, ≤0.88) and good intra-assay variability in laboratory 3 (correlation coefficient, ≤0.93). Interlaboratory correlations, likewise, ranged between 0.61 and 0.80 in both case-control study subjects and healthy blood donors, indicating that ELISA optical density (OD) values between laboratories were linearly related regardless of the population. Kappa coefficients (κ), based on each laboratory's categorical interpretation of its results (as positive or negative), showed good agreement (κ, >0.6) in case-control study subjects and moderate agreement (κ, ≤0.4) in blood donors, a population that had few strongly positive sera. When OD values near seropositive cutoffs were treated as indeterminates, there was little discordance between laboratories in either population. The data suggest that each laboratory measured the same humoral immune response and that their HPV-16 VLP ELISAs performed similarly (Pearson correlations). Interlaboratory differences, however, probably due to reagents and procedures, were considerably greater than intralaboratory day- to-day variability. Interlaboratory agreement in determining seropositivity (κ) could be improved by sharing positive and negative serum controls and by treating marginal results as indeterminate. As part of continuing cooperation to improve interlaboratory agreement, we are preparing bulk serum control specimens to be shared and made available to interested researchers.

Original languageEnglish (US)
Pages (from-to)1751-1756
Number of pages6
JournalJournal of Clinical Microbiology
Volume35
Issue number7
StatePublished - Jul 1997
Externally publishedYes

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Human papillomavirus 16
Enzyme-Linked Immunosorbent Assay
Papillomaviridae
Blood Donors
Case-Control Studies
Virion
Healthy Volunteers
Serum
Vulvar Neoplasms
Population
Humoral Immunity
Research Personnel
Antibodies

ASJC Scopus subject areas

  • Microbiology (medical)
  • Microbiology

Cite this

Strickler, H., Hildesheim, A., Viscidi, R. P., Shah, K. V., Goebel, B., Drummond, J., ... Schiller, J. T. (1997). Interlaboratory agreement among results of human papillomavirus type 16 enzyme-linked immunosorbent assays. Journal of Clinical Microbiology, 35(7), 1751-1756.

Interlaboratory agreement among results of human papillomavirus type 16 enzyme-linked immunosorbent assays. / Strickler, Howard; Hildesheim, Allan; Viscidi, Raphael P.; Shah, Keerti V.; Goebel, Brad; Drummond, James; Waters, David; Sun, Yeping; Hubbert, Nancy L.; Wacholder, Sholom; Brinton, Louise A.; Han, Cheng Long; Nasca, Philip C.; McClimens, Roberta; Turk, Karen; Devairakkam, Violet; Leitman, Susan; Martin, Cynthia; Schiller, John T.

In: Journal of Clinical Microbiology, Vol. 35, No. 7, 07.1997, p. 1751-1756.

Research output: Contribution to journalArticle

Strickler, H, Hildesheim, A, Viscidi, RP, Shah, KV, Goebel, B, Drummond, J, Waters, D, Sun, Y, Hubbert, NL, Wacholder, S, Brinton, LA, Han, CL, Nasca, PC, McClimens, R, Turk, K, Devairakkam, V, Leitman, S, Martin, C & Schiller, JT 1997, 'Interlaboratory agreement among results of human papillomavirus type 16 enzyme-linked immunosorbent assays', Journal of Clinical Microbiology, vol. 35, no. 7, pp. 1751-1756.
Strickler, Howard ; Hildesheim, Allan ; Viscidi, Raphael P. ; Shah, Keerti V. ; Goebel, Brad ; Drummond, James ; Waters, David ; Sun, Yeping ; Hubbert, Nancy L. ; Wacholder, Sholom ; Brinton, Louise A. ; Han, Cheng Long ; Nasca, Philip C. ; McClimens, Roberta ; Turk, Karen ; Devairakkam, Violet ; Leitman, Susan ; Martin, Cynthia ; Schiller, John T. / Interlaboratory agreement among results of human papillomavirus type 16 enzyme-linked immunosorbent assays. In: Journal of Clinical Microbiology. 1997 ; Vol. 35, No. 7. pp. 1751-1756.
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abstract = "Serological assays for measuring antibodies to human papillomavirus type 16 (HPV-16) virus-like particles (VLPs) have become important epidemiologic tools in recent years. However, the interlaboratory replicability of these assays has not been assessed. In this investigation, three laboratories tested a panel of specimens obtained from two different groups: 265 subjects in a vulvar cancer case-control study and 107 healthy volunteer blood donors. Each laboratory used an enzyme-linked immunosorbent assay (ELISA), but no attempt was made to standardize assay procedures among the three laboratories. The data showed good day-to-day intralaboratory replicability in laboratory 1 (correlation coefficient, ≤0.88) and good intra-assay variability in laboratory 3 (correlation coefficient, ≤0.93). Interlaboratory correlations, likewise, ranged between 0.61 and 0.80 in both case-control study subjects and healthy blood donors, indicating that ELISA optical density (OD) values between laboratories were linearly related regardless of the population. Kappa coefficients (κ), based on each laboratory's categorical interpretation of its results (as positive or negative), showed good agreement (κ, >0.6) in case-control study subjects and moderate agreement (κ, ≤0.4) in blood donors, a population that had few strongly positive sera. When OD values near seropositive cutoffs were treated as indeterminates, there was little discordance between laboratories in either population. The data suggest that each laboratory measured the same humoral immune response and that their HPV-16 VLP ELISAs performed similarly (Pearson correlations). Interlaboratory differences, however, probably due to reagents and procedures, were considerably greater than intralaboratory day- to-day variability. Interlaboratory agreement in determining seropositivity (κ) could be improved by sharing positive and negative serum controls and by treating marginal results as indeterminate. As part of continuing cooperation to improve interlaboratory agreement, we are preparing bulk serum control specimens to be shared and made available to interested researchers.",
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AU - Goebel, Brad

AU - Drummond, James

AU - Waters, David

AU - Sun, Yeping

AU - Hubbert, Nancy L.

AU - Wacholder, Sholom

AU - Brinton, Louise A.

AU - Han, Cheng Long

AU - Nasca, Philip C.

AU - McClimens, Roberta

AU - Turk, Karen

AU - Devairakkam, Violet

AU - Leitman, Susan

AU - Martin, Cynthia

AU - Schiller, John T.

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