European Sero-Epidemiology Network 2: Standardisation of immunoassay results for pertussis requires homogeneity in the antigenic preparations

Giammanco, Anna; Nardone, A; Pebody, Richard; Kafatos, George; Andrews, Nick; Chiarini, A; Taormina, Susanna; Ory, Fernando de; Prosenc, Katarina; Krize, Bohumir; Hallander, Hans O.; Ljungman, Margaretha; Marva, Esther; Tsakris, Athanassios; O’Flanagan, D; Schneider, François; Griskevicius, Algirdas; Vranckx, R.; Karacs, I.

doi:10.1016/j.vaccine.2008.06.051

Cited by 18 publications

(13 citation statements)

References 24 publications

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“…One PT-containing kit (Virotech PT) was evaluated prior to being used in a European seroepidemiology study (ESEN), and these results were very comparable to our findings (17). The ESEN study also stressed the importance of antigen preparations for PT-containing ELISAs (6). In accordance with those findings, we observed that in three patient sera anti-PT IgG levels of Ͼ100 IU/ml were detected by the in-house ELISA and by one commercial ELISA but not by two other commercial ELISAs using a different source of PT.…”

Section: Discussionsupporting

confidence: 88%

Performance of Commercial Enzyme-Linked Immunosorbent Assays for Detection of Antibodies to Bordetella pertussis

et al. 2010

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Measuring antibodies to Bordetella pertussis antigens is mostly done by enzyme-linked immunosorbent assays (ELISAs). We compared the performance of ELISA kits that were commercially available in Germany. Eleven measured IgG antibodies, and nine measured IgA antibodies. An in-house ELISA with purified antigens served as a reference method. Samples included two WHO reference preparations, the former Food and Drug Administration (FDA)/Center for Biologics Evaluation and Research (CBER) reference preparations, serum samples from patients with clinically suspected pertussis, and serum samples from patients having received a combined tetanus, diphtheria, and pertussis (Tdap) vaccination. Kits using pertussis toxin (PT) as an antigen showed linearity compared to the WHO Reference preparation (r 2 between 0.82 and 0.99), and these kits could quantify antibodies according to the reference preparation. ELISA kits using mixed antigens showed no linear correlation to the reference preparations. Patient results were compared to results of in-house ELISAs using a dual cutoff of either >100 IU/ml anti-PT IgG or >40 IU/ml anti-PT IgG together with >12 IU/ml anti-PT IgA. The sensitivities of kits measuring IgG antibodies ranged between 0.84 and 1.00. The specificities of kits using PT as an antigen were between 0.81 and 0.93. The specificities of kits using mixed antigens were between 0.51 and 0.59 and were thus not acceptable. The sensitivities of kits measuring IgA antibodies ranged between 0.53 and 0.73, and the specificities were between 0.67 and 0.94, indicating that IgA antibodies may be of limited diagnostic value. Our data suggest that ELISAs should use purified PT as an antigen and be standardized to the 1st International Reference preparation.

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Section: Discussionsupporting

confidence: 88%

Performance of Commercial Enzyme-Linked Immunosorbent Assays for Detection of Antibodies to Bordetella pertussis

et al. 2010

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“…La PCR fue adoptada como método confirmatorio por ser una técnica rápida, con buena sensibilidad y especificidad, como sucedió en Estados Unidos (1996), Francia, Alemania. 4,[25][26][27] A partir del año 2011, el SNVS, basándose en la mejora en el diagnóstico, incorpora la variable "clasificación epidemiológica" con la posibilidad de definir los casos de la enfermedad como confirmados, probables y descartados, en consecuencia, se pudo determinar con mayor precisión la incidencia de la enfermedad, que es el principal indicador del impacto de la inmunización y es útil para monitorear la tendencia. 28 Por esta razón, no se cuenta con datos históricos de casos confirmados entre 2002 y 2010 ya que esta clasificación final no existía en el módulo C2.…”

Section: Discussionunclassified

Situación epidemiológica de coqueluche y estrategias para su control. Argentina, 2002-2011

et al. 2014

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“…In this study, we compared the Viramed immunoblot with the Virotech immunoblot using an ELISA as a reference method in the absence of patient histories or culture results; however, it has been established that a rise in anti-B. pertussis antibodies against PT and FHA is a clear indication of either active disease or vaccination (7,(10)(11)(12).…”

Section: Discussionmentioning

confidence: 99%

“…Numerous studies, however, have established that there is an increase in anti-pertussis toxin (PT) and anti-filamentous hemagglutinin (FHA) serum antibodies during Bordetella infection and that the measurement of these antibodies could assist in the laboratory confirmation of pertussis (7,(10)(11)(12). Since PT is produced only by B. pertussis, anti-PT antibodies are highly specific for B. pertussis infection (18,20).…”

mentioning

confidence: 99%

Comparison of Western Immunobloting to an Enzyme-Linked Immunosorbent Assay for the Determination of Anti-Bordetella pertussis Antibodies

Merrigan

Welch

Litwin

2011

Clin. Vaccine Immunol.

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European Sero-Epidemiology Network 2: Standardisation of immunoassay results for pertussis requires homogeneity in the antigenic preparations

Cited by 18 publications

References 24 publications

Performance of Commercial Enzyme-Linked Immunosorbent Assays for Detection of Antibodies to Bordetella pertussis

Performance of Commercial Enzyme-Linked Immunosorbent Assays for Detection of Antibodies to Bordetella pertussis

Situación epidemiológica de coqueluche y estrategias para su control. Argentina, 2002-2011

Comparison of Western Immunobloting to an Enzyme-Linked Immunosorbent Assay for the Determination of Anti-Bordetella pertussis Antibodies

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