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Genitourin Med. 1997 June; 73(3): 207–211.
PMCID: PMC1195824

Differences in the sensitivity of the Amplicor Chlamydia trachomatis PCR assay.

Abstract

PURPOSE: To evaluate the use of the Amplicor PCR assay in two European centres (Amsterdam and Vienna) as a standard for amplification assays in comparative studies. STUDY DESIGN: Both centres used the Amplicor PCR assay and their own standard diagnostic methods as the reference assay. Discrepant results were further analysed by an Omp1-PCR assay. In total 805 female patients and 614 male patients were included in the studies. RESULTS: The prevalence of Chlamydia trachomatis infections in female patients was 10.0% in Amsterdam and 2.5% in Vienna and in male patients 13.7% and 10.8%, respectively. The mean sensitivity of the Amplicor PCR assay with cervical specimens from female patients was 92.5% and the mean specificity was 99.2%. For the reference assays the mean values were 87.5% and 100.0% respectively. The mean sensitivity of the Amplicor PCR assay with urine specimens from male patients was 70.3% and the mean specificity was 97.6%. For the reference assays these values were 64.9% and 100.0% respectively. The mean sensitivity of the Amplicor PCR assay with urethral specimens from male patients was 67.6% and the mean specificity was 98.5%. For the reference assays these values were 62.2% and 100.0% respectively. Of all specimens together, 1.0% showed an OD value between 0.25 and 0.5 in the Amplicor PCR assay and had to be retested. The sensitivity of the Amplicor PCR assay was less than could be expected from previous studies comparing amplification assays under similar conditions. Also, the sensitivity of the Amplicor PCR assay varied considerably between study centres using urine specimens from male patients-45.9% and 94.6%, respectively. CONCLUSION: The Amplicor PCR assay cannot be considered as a standard for amplification assays in comparative studies.

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Selected References

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  • Taylor-Robinson D. Chlamydia trachomatis and sexually transmitted disease. BMJ. 1994 Jan 15;308(6922):150–151. [PMC free article] [PubMed]
  • Barnes RC. Laboratory diagnosis of human chlamydial infections. Clin Microbiol Rev. 1989 Apr;2(2):119–136. [PMC free article] [PubMed]
  • Taylor-Robinson D. Laboratory methods for chlamydial infections. J Infect. 1992 Jul;25 (Suppl 1):61–67. [PubMed]
  • Taylor-Robinson D. The value of non-culture techniques for diagnosis of Chlamydia trachomatis infections: making the best of a bad job. Eur J Clin Microbiol Infect Dis. 1992 Jun;11(6):499–503. [PubMed]
  • Ilstrup DM. Statistical methods in microbiology. Clin Microbiol Rev. 1990 Jul;3(3):219–226. [PMC free article] [PubMed]
  • Pate MS, Hook EW., 3rd Laboratory to laboratory variation in Chlamydia trachomatis culture practices. Sex Transm Dis. 1995 Sep-Oct;22(5):322–326. [PubMed]
  • Saiki RK, Gelfand DH, Stoffel S, Scharf SJ, Higuchi R, Horn GT, Mullis KB, Erlich HA. Primer-directed enzymatic amplification of DNA with a thermostable DNA polymerase. Science. 1988 Jan 29;239(4839):487–491. [PubMed]
  • Ossewaarde JM, Rieffe M, Rozenberg-Arska M, Ossenkoppele PM, Nawrocki RP, van Loon AM. Development and clinical evaluation of a polymerase chain reaction test for detection of Chlamydia trachomatis. J Clin Microbiol. 1992 Aug;30(8):2122–2128. [PMC free article] [PubMed]
  • Schachter J, Stamm WE, Chernesky MA, Hook EW, 3rd, Jones RB, Judson FN, Kellogg JA, LeBar B, Mårdh PA, McCormack WM, et al. Nonculture tests for genital tract chlamydial infection. What does the package insert mean, and will it mean the same thing tomorrow? Sex Transm Dis. 1992 Sep-Oct;19(5):243–244. [PubMed]
  • Loeffelholz MJ, Lewinski CA, Silver SR, Purohit AP, Herman SA, Buonagurio DA, Dragon EA. Detection of Chlamydia trachomatis in endocervical specimens by polymerase chain reaction. J Clin Microbiol. 1992 Nov;30(11):2847–2851. [PMC free article] [PubMed]
  • Coughlin SS, Trock B, Criqui MH, Pickle LW, Browner D, Tefft MC. The logistic modeling of sensitivity, specificity, and predictive value of a diagnostic test. J Clin Epidemiol. 1992 Jan;45(1):1–7. [PubMed]
  • Miyashita N, Lijima Y, Matsumoto A. Evaluation of the sensitivity and specificity of polymerase chain reaction test kit, AMPLICOR Chlamydia trachomatis. Microbiol Immunol. 1994;38(1):81–85. [PubMed]
  • Smith IW, Morrison CL, Patrizio C, McMillan A. Use of a commercial PCR kit for detecting Chlamydia trachomatis. J Clin Pathol. 1993 Sep;46(9):822–825. [PMC free article] [PubMed]
  • de Barbeyrac B, Pellet I, Dutilh B, Bébéar C, Dumon B, Géniaux M, Bébéar C. Evaluation of the Amplicor Chlamydia trachomatis test versus culture in genital samples in various prevalence populations. Genitourin Med. 1994 Jun;70(3):162–166. [PMC free article] [PubMed]
  • Bauwens JE, Clark AM, Stamm WE. Diagnosis of Chlamydia trachomatis endocervical infections by a commercial polymerase chain reaction assay. J Clin Microbiol. 1993 Nov;31(11):3023–3027. [PMC free article] [PubMed]
  • Jaschek G, Gaydos CA, Welsh LE, Quinn TC. Direct detection of Chlamydia trachomatis in urine specimens from symptomatic and asymptomatic men by using a rapid polymerase chain reaction assay. J Clin Microbiol. 1993 May;31(5):1209–1212. [PMC free article] [PubMed]
  • Bauwens JE, Clark AM, Loeffelholz MJ, Herman SA, Stamm WE. Diagnosis of Chlamydia trachomatis urethritis in men by polymerase chain reaction assay of first-catch urine. J Clin Microbiol. 1993 Nov;31(11):3013–3016. [PMC free article] [PubMed]
  • Stary A, Teodorowicz L, Hörting-Müller I, Nerad S, Storch M. Evaluation of the Gen-Probe PACE 2 and the Microtrak enzyme immunoassay for diagnosis of Chlamydia trachomatis in urogenital samples. Sex Transm Dis. 1994 Jan-Feb;21(1):26–30. [PubMed]
  • Ossewaarde JM, Rieffe M, van Doornum GJ, Henquet CJ, van Loon AM. Detection of amplified Chlamydia trachomatis DNA using a microtiter plate-based enzyme immunoassay. Eur J Clin Microbiol Infect Dis. 1994 Sep;13(9):732–740. [PubMed]
  • van Doornum GJ, Buimer M, Prins M, Henquet CJ, Coutinho RA, Plier PK, Tomazic-Allen S, Hu H, Lee H. Detection of Chlamydia trachomatis infection in urine samples from men and women by ligase chain reaction. J Clin Microbiol. 1995 Aug;33(8):2042–2047. [PMC free article] [PubMed]
  • Thomas BJ, MacLeod EJ, Taylor-Robinson D. Evaluation of a commercial polymerase chain reaction assay for Chlamydia trachomatis and suggestions for improving sensitivity. Eur J Clin Microbiol Infect Dis. 1995 Aug;14(8):719–723. [PubMed]
  • Kellogg JA, Seiple JW, Klinedinst JL, Stroll ES, Cavanaugh SH. Improved PCR detection of Chlamydia trachomatis by using an altered method of specimen transport and high-quality endocervical specimens. J Clin Microbiol. 1995 Oct;33(10):2765–2767. [PMC free article] [PubMed]

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