• We are sorry, but NCBI web applications do not support your browser and may not function properly. More information
Logo of jcmPermissionsJournals.ASM.orgJournalJCM ArticleJournal InfoAuthorsReviewers
J Clin Microbiol. Jan 1997; 35(1): 174–178.
PMCID: PMC229533

False-positive results in immunoglobulin M (IgM) toxoplasma antibody tests and importance of confirmatory testing: the Platelia Toxo IgM test.

Abstract

Although tests for detection of immunoglobulin M (IgM) toxoplasma antibodies have been reported to have a high degree of accuracy, it is well recognized by investigators in the United States and Europe that false-positive results may occur with many of these tests, at times to an alarming degree. Unfortunately, this information is not well documented in the literature. Studies on various toxoplasma IgM test kits are frequently flawed. The investigators often use reference tests which have not previously been carefully evaluated as well as sera that were not appropriate to answer the question of how often false-positive results might occur. We recently had the unique opportunity to evaluate the accuracy of the Platelia Toxo IgM test in 575 serum samples obtained during an outbreak of toxoplasmosis which occurred in 1995 in the Capital Regional District of British Columbia, Canada. When compared with results obtained in a reference IgM enzyme-linked immunosorbent assay (ELISA), the Platelia Toxo IgM test had a sensitivity of 99.4%, specificity of 49.2%, positive predictive value of 51.9%, negative predictive value of 99.3%, and an overall agreement of 67.0%. In an attempt to resolve discrepancies between these two tests, a serological profile (Sabin-Feldman dye test, IgA and IgE antibody tests, differential agglutination [AC/HS] test, and IgG avidity method) was performed. Of 153 serum samples that were positive in the Platelia Toxo IgM test and negative in the IgM ELISA, 71 (46.4%) were negative in the Sabin-Feldman dye test. Of the serum samples that were positive in the dye test, 77 (93.9%) had a serological profile most compatible with an infection acquired in the distant past. These results reveal high numbers of false-positive results in the Platelia Toxo IgM test and highlight the importance of appropriate evaluation of commercial tests that are currently being marked. Our results also emphasize the importance of confirmatory testing to determine whether the results of an IgM antibody test reflect the likelihood of a recently acquired infection.

Full Text

The Full Text of this article is available as a PDF (168K).

Selected References

These references are in PubMed. This may not be the complete list of references from this article.
  • Ashburn D, Evans R, Skinner LJ, Chatterton JM, Joss AW, Ho-Yen DO. Comparison of relative uses of commercial assays for Toxoplasma gondii IgM antibodies. J Clin Pathol. 1992 Jun;45(6):483–486. [PMC free article] [PubMed]
  • Bobić B, Sibalić D, Djurković-Djaković O. High levels of IgM antibodies specific for Toxoplasma gondii in pregnancy 12 years after primary toxoplasma infection. Case report. Gynecol Obstet Invest. 1991;31(3):182–184. [PubMed]
  • Candolfi E, Ramirez R, Hadju MP, Shubert C, Remington JS. The Vitek immunodiagnostic assay for detection of immunoglobulin M toxoplasma antibodies. Clin Diagn Lab Immunol. 1994 Jul;1(4):401–405. [PMC free article] [PubMed]
  • Crouch CF. Enzyme immunoassays for IgG and IgM antibodies to Toxoplasma gondii based on enhanced chemiluminescence. J Clin Pathol. 1995 Jul;48(7):652–657. [PMC free article] [PubMed]
  • Dannemann BR, Vaughan WC, Thulliez P, Remington JS. Differential agglutination test for diagnosis of recently acquired infection with Toxoplasma gondii. J Clin Microbiol. 1990 Sep;28(9):1928–1933. [PMC free article] [PubMed]
  • Del Bono V, Canessa A, Bruzzi P, Fiorelli MA, Terragna A. Significance of specific immunoglobulin M in the chronological diagnosis of 38 cases of toxoplasmic lymphadenopathy. J Clin Microbiol. 1989 Sep;27(9):2133–2135. [PMC free article] [PubMed]
  • Gorgievski-Hrisoho M, Germann D, Matter L. Diagnostic implications of kinetics of immunoglobulin M and A antibody responses to Toxoplasma gondii. J Clin Microbiol. 1996 Jun;34(6):1506–1511. [PMC free article] [PubMed]
  • Goullier-Fleuret A, Picot S. Etude multicentrique de l'enzymun-test Toxo-IgG et IgM. Ann Biol Clin (Paris) 1989;47(7):397–400. [PubMed]
  • Hall AV, Johnson JD, Stevens PJ, Renton NE, Holliman RE. Measurement of Toxoplasma IgM by a microparticle capture enzyme immuno-assay. J Med Microbiol. 1993 Jan;38(1):34–37. [PubMed]
  • Hedman K, Lappalainen M, Seppäiä I, Mäkelä O. Recent primary toxoplasma infection indicated by a low avidity of specific IgG. J Infect Dis. 1989 Apr;159(4):736–740. [PubMed]
  • Herbrink P, van Loon AM, Rotmans JP, van Knapen F, van Dijk WC. Interlaboratory evaluation of indirect enzyme-linked immunosorbent assay, antibody capture enzyme-linked immunosorbent assay, and immunoblotting for detection of immunoglobulin M antibodies to Toxoplasma gondii. J Clin Microbiol. 1987 Jan;25(1):100–105. [PMC free article] [PubMed]
  • Ilstrup DM. Statistical methods in microbiology. Clin Microbiol Rev. 1990 Jul;3(3):219–226. [PMC free article] [PubMed]
  • Joynson DH, Payne RA, Balfour AH, Prestage ES, Fleck DG, Chessum BS. Five commercial enzyme linked immunosorbent assay kits for toxoplasma specific IgM antibody. J Clin Pathol. 1989 Jun;42(6):653–657. [PMC free article] [PubMed]
  • Lappalainen M, Koskela P, Koskiniemi M, Ammälä P, Hiilesmaa V, Teramo K, Raivio KO, Remington JS, Hedman K. Toxoplasmosis acquired during pregnancy: improved serodiagnosis based on avidity of IgG. J Infect Dis. 1993 Mar;167(3):691–697. [PubMed]
  • Liesenfeld O, Press C, Flanders R, Ramirez R, Remington JS. Study of Abbott Toxo IMx system for detection of immunoglobulin G and immunoglobulin M toxoplasma antibodies: value of confirmatory testing for diagnosis of acute toxoplasmosis. J Clin Microbiol. 1996 Oct;34(10):2526–2530. [PMC free article] [PubMed]
  • Luyasu V, Robert AR, Schaefer L, Macioszek J. Multicenter evaluation of a new commercial assay for detection of immunoglobulin M antibodies to Toxoplasma gondii. Multicenter Study Group. Eur J Clin Microbiol Infect Dis. 1995 Sep;14(9):787–793. [PubMed]
  • Montoya JG, Remington JS. Studies on the serodiagnosis of toxoplasmic lymphadenitis. Clin Infect Dis. 1995 Apr;20(4):781–789. [PubMed]
  • Naot Y, Remington JS. An enzyme-linked immunosorbent assay for detection of IgM antibodies to Toxoplasma gondii: use for diagnosis of acute acquired toxoplasmosis. J Infect Dis. 1980 Nov;142(5):757–766. [PubMed]
  • Pelloux H, Ciapa P, Goullier-Fleuret A, Ambroise-Thomas P. Evaluation du système Vidas pour le diagnostic sérologique de la toxoplasmose. Ann Biol Clin (Paris) 1993;51(10-11):875–878. [PubMed]
  • Petithory JC, Reiter-Owona I, Berthelot F, Milgram M, De Loye J, Petersen E. Performance of European laboratories testing serum samples for Toxoplasma gondii. Eur J Clin Microbiol Infect Dis. 1996 Jan;15(1):45–49. [PubMed]
  • Rotmans J, Duchenne W, Linschooten C, In't Veld N, Polderman A. Comparative study of three immunoassays for detection of immunoglobulin M antibodies against Toxoplasma gondii. Eur J Clin Microbiol Infect Dis. 1988 Aug;7(4):535–538. [PubMed]
  • Sabin AB, Feldman HA. Dyes as Microchemical Indicators of a New Immunity Phenomenon Affecting a Protozoon Parasite (Toxoplasma). Science. 1948 Dec 10;108(2815):660–663. [PubMed]
  • Safford JW, Abbott GG, Craine MC, MacDonald RG. Automated microparticle enzyme immunoassays for IgG and IgM antibodies to Toxoplasma gondii. J Clin Pathol. 1991 Mar;44(3):238–242. [PMC free article] [PubMed]
  • Schaefer LE, Dyke JW, Meglio FD, Murray PR, Crafts W, Niles AC. Evaluation of microparticle enzyme immunoassays for immunoglobulins G and M to rubella virus and Toxoplasma gondii on the Abbott IMx automated analyzer. J Clin Microbiol. 1989 Nov;27(11):2410–2413. [PMC free article] [PubMed]
  • Stepick-Biek P, Thulliez P, Araujo FG, Remington JS. IgA antibodies for diagnosis of acute congenital and acquired toxoplasmosis. J Infect Dis. 1990 Jul;162(1):270–273. [PubMed]
  • Van Enk RA, James KK, Thompson KD. Evaluation of three commercial enzyme immunoassays for toxoplasma and cytomegalovirus antibodies. Am J Clin Pathol. 1991 Mar;95(3):428–434. [PubMed]
  • Verhofstede C, Van Renterghem L, Plum J. Comparison of six commercial enzyme linked immunosorbent assays for detecting IgM antibodies against Toxoplasma gondii. J Clin Pathol. 1989 Dec;42(12):1285–1290. [PMC free article] [PubMed]
  • Wong SY, Hajdu MP, Ramirez R, Thulliez P, McLeod R, Remington JS. Role of specific immunoglobulin E in diagnosis of acute toxoplasma infection and toxoplasmosis. J Clin Microbiol. 1993 Nov;31(11):2952–2959. [PMC free article] [PubMed]
  • Wong SY, Remington JS. Toxoplasmosis in pregnancy. Clin Infect Dis. 1994 Jun;18(6):853–862. [PubMed]

Articles from Journal of Clinical Microbiology are provided here courtesy of American Society for Microbiology (ASM)

Formats:

Related citations in PubMed

See reviews...See all...

Cited by other articles in PMC

See all...

Links

  • MedGen
    MedGen
    Related information in MedGen
  • PubMed
    PubMed
    PubMed citations for these articles
  • Substance
    Substance
    PubChem Substance links

Recent Activity

Your browsing activity is empty.

Activity recording is turned off.

Turn recording back on

See more...