Performance of the elecsys rubella IgG assay in the diagnostic laboratory setting for assessment of immune status

Clinical and Vaccine Immunology

Volumn 20, Issue 3, 2013, Pages 420-426

  Enders, Martin ^a   Bartelt, Uwe ^a   Knotek, Frank ^a   Bunn, Kristina ^a   Strobel, Sirpa ^a   Dietz, Klaus ^b   Endersa, Gisela ^a  

^a Laboratory Prof Gisela Enders and Colleagues   (Germany)

^b UNIVERSITY OF TÜBINGEN   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

IMMUNOGLOBULIN G;

ADOLESCENT; ADULT; ANTIBODY TITER; ARTICLE; CONTROLLED STUDY; DIAGNOSTIC TEST; FEMALE; HEMAGGLUTINATION INHIBITION TEST; HUMAN; IMMUNE STATUS; IMMUNOASSAY; INTERMETHOD COMPARISON; LABORATORY TEST; MAJOR CLINICAL STUDY; PRENATAL CARE; PRIORITY JOURNAL; QUALITATIVE DIAGNOSIS; RUBELLA; SENSITIVITY AND SPECIFICITY;

ADOLESCENT; ADULT; ANTIBODIES, VIRAL; CLINICAL LABORATORY TECHNIQUES; FEMALE; HUMANS; IMMUNOGLOBULIN G; MASS SCREENING; PREGNANCY; RUBELLA; SENSITIVITY AND SPECIFICITY; YOUNG ADULT;

EID: 84875049980     PISSN: 15566811     EISSN: 1556679X     Source Type: Journal    
DOI: 10.1128/CVI.00688-12     Document Type: Article

References (34)

1. Duszak RS. 2009. Congenital rubella syndrome-major review. Optometry 80:36-43.
2. National Institute for Health and Clinical Excellence. 2010. Antenatal care. Routine care for the healthy pregnant woman. National Institute for Health and Clinical Excellence, London, United Kingdom. http://www .nice.org.uk/nicemedia/pdf/CG062NICEguideline.pdf. Accessed November 2012.
3. World Health Organization. 2007. Manual for the laboratory diagnosis of measles and rubella virus infection. WHO/IVB/07.01, 2nd ed. World Health Organization, Geneva, Switzerland. http://www.who.int/immunization -monitoring/LabManualFinal.pdf. Accessed November 2012.
4. World Health Organization. 2008. The immunological basis for immunization series. Module 11: rubella. http://whqlibdoc.who.int/publications/2008/ 9789241596848-eng.pdf. Accessed November 2012.
5. Australian Technical Advisory Group on Immunisation (ATAGI). 2008. The Australian immunisation handbook, 9th edition. Australian Government Department of Health and Ageing, Canberra, Australia. http://www.health.gov.au/internet/ immunise/publishing.nsf/Content/Handbook-home. Accessed January 2013.
6. Kirkham C, Harris S, Grzybowski S. 2005. Evidence-based prenatal care: part II. Third-trimester care and prevention of infectious diseases. Am. Fam. Physician 71:1555-1560.
7. Texas Department of State Health Services. 2012. Rubella. Texas Department of State Health Services, Austin, Texas. http://www.dshs.state.tx.us/ idcu/disease/rubella/. Accessed January 2013.
8. McLean H, Redd S, Abernathy E, Icenogle J, Wallace G. 2012. Rubella, chapter 14. In Roush SW, McIntyre L, Baldy LM (ed), Manual for the surveillance of vaccine-preventable diseases, 5th ed. Centers for Disease Control and Prevention, Atlanta, GA. http://www.cdc.gov/vaccines/pubs/surv-manual/chpt14- rubella.pdf. Accessed January 2013
9. Akkerman D, Cleland L, Croft G, Eskuchen K, Heim C, Levine A, Setterlund L, Stark C, Vickers J, Westby E. 2012. Routine prenatal care. Institute for Clinical Systems Improvement, Cambridge, MA. http://www.primarycareguidelines. com/uploads/5/8/1/0/5810751/icsi 2012-prenatal.pdf. Accessed January 2013.
10. Public Health Agency of Canada. 2013. Canadian immunization guide: rubella vaccine. Public Health Agency of Canada, Ottawa, Ontario, Canada. http://www.phac-aspc.gc.ca/publicat/cig-gci/p04-rube-eng.php. Accessed January 2013.
11. Haute Autorité de Santé France. 2009. Surveillance sérologique et prévention de la toxoplasmose et de la rubéole au cours de la grossesse. Haute Autorité de Santé France, Paris, France. http://www.has-sante.fr/portail/upload/docs/application/ pdf/2009-12/depistages-prenatals-obligatoires-synthese -vf.pdf. Accessed January 2013. (In French.)
12. Mutterschafts-Richtlinien. 18 August 2011. Umsetzung der Schutzimpfungs-Richtlinien-Test auf Rötelnantikörper und Erfassung der Immunitätslage. In Bundesanzeiger, no. 124. Gemeinsamer Bundesausschuss, Berlin, Germany. http://www.g-ba.de/informationen/beschluesse/1323/. Accessed December 2012. (In German.)
13. Bundesamt für Gesundheit Eidgenössische Kommission für Impffragen Schweizerischen Gesellschaft für Gynäkologie und Geburtshilfe. 2006.
14. Impfung von Frauen im gebärfähigen Alter gegen Röteln, Masern, Mumps und Varizellen. Richtlinien und Empfehlungen. Federal Office of Public Health, Bern, Switzerland. http://www.bag.admin.ch/themen/medizin/00682/ 00685/02114/. Accessed January 2013. (In German.)
15. Mutterschafts-Richtlinien. 27 May 1985. Richtlinien des Bundesausschusses der Ärzte und Krankenkassen über die ärztliche Betreuung während der Schwangerschaft und nach der Entbindung. In Bundesanzeiger, vol. 60a. Gemeinsamer Bundesausschuss, Berlin, Germany. (In German.)
16. Skendzel LP. 1996. Rubella immunity. Defining the level of protective antibody. Am. J. Clin. Pathol. 106:170-174.
17. Skendzel LP, Kiefer DJ, Nakamura RM, Nutter CD, Schaefer LE, Stewart JA. 1997. Detection and quantitation of rubella IgG antibody: evaluation and performance criteria for multiple component test products, specimen handling, and use of test products in the clinical laboratory; approved guideline. I/LA6-A. NCCLS, Wayne, PA.
18. Best JM, Enders G. 2007. Laboratory diagnosis of rubella and congenital rubella, p 39-77. In Banatvala J, PeckhamC(ed), Rubella viruses. Perspectives in medical virology, 1st ed. Elsevier Life Sciences, London, United Kingdom.
19. Mendelson E, Aboudy Y, Smetana Z, Tepperberg M, Grossman Z. 2006. Laboratory assessment and diagnosis of congenital viral infections: rubella, cytomegalovirus (CMV), varicella-zoster virus (VZV), herpes simplex virus (HSV), parvovirus B19 and human immunodeficiency virus (HIV). Reprod. Toxicol. 21:350-382.
20. Enders G, Knotek F. 1985. Comparison of the performance and reproducibility of various serological methods and diagnostic kits for the detection of rubella antibodies. J. Virol. Methods 11:1-14.
21. Terletskaia-Ladwig E, Enders G, Meier S, Dietz K, Enders M. 2011. Development and evaluation of an automatable focus reduction neutralisation test for the detection of measles virus antibodies using imaging analysis. J. Virol. Methods 178:124-128.
22. Tian I. 2005. Inferences on the mean of zero-inflated lognormal data: the generalized variable approach. Stat. Med. 24:3223-3232.
23. Bland JM, Altman DG. 1986. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet i:307-310.
24. Holm S. 1979. A simple sequentially rejective multiple test procedure. Scand. J. Stat. 6:65-70.
25. Lin LI. 1989. A concordance correlation coefficient to evaluate reproducibility. Biometrics 45:255-268.
26. McBride GB. 2005. A proposal for strength-of-agreement criteria for Lin's concordance correlation coefficient. NIWA client report: HAM2005-062. MedCalc Software, Ostend, Belgium. http://www.medcalc.org/download/pdf/McBride2005.pdf. Accessed November 2012.
27. Dimech W, Panagiotopoulos L, Francis B, Laven N, Marler J, Dickeson D, Panayotou T, Wilson K, Wootten R, Dax EM. 2008. Evaluation of eight anti-rubella virus immunoglobulin G immunoassays that report results in international units per millilitre. J. Clin. Microbiol. 46:1955-1960.
28. Haukenes G, Blom H. 1975. False positive rubella virus haemagglutination inhibition reactions: occurrence and disclosure. Med. Microbiol. Immunol. 161:99-106.
29. Medici MC, Martinelli M, Albonetti V, Chezzi C, Dettori G. 2008. Evaluation of rubella virus immunoglobulin G (IgG) and IgM assays with the new Vidia instrument. J. Clin. Microbiol. 46:1847-1849.
30. O'Shea S, Dunn H, Palmer S, Bantavala JE, Best JM. 1999. Automated rubella antibody screening: a cautionary tale. J. Med. Microbiol. 48:1047.doi:10.1099/00222615-48-11-1047.
31. Best JM, Banatvala JE, Morgan-Capner P, Miller E. 1989. Fetal infection after maternal reinfection with rubella: criteria for defining reinfection. BMJ 299:773-775.
32. National Institute for Biological Standards and Control. 1995. WHO 1st international standard anti rubella immunoglobulin, human. National Institute for Biological Standards and Control, Hertfordshire, United Kingdom. http://www.nibsc.ac.uk/documents/ifu/RUBI-1-94.pdf. Accessed November 2012.
33. Poethko-Müller C, Mankertz A. 2012. Seroprevalence of measles-, mumps-and rubella-specific IgG antibodies in German children and adolescents and predictors for seronegativity. PLoS One 7:e42867. doi:10 .1371/journal.pone. 0042867.
34. Reiter S, Poethko-Müller C. 2009. Current vaccination coverage and immunization gaps of children and adolescents in Germany. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz 52:1037-1044. (In German.)