Multicenter evaluation of AMPLICOR and automated COBAS AMPLICOR CT/NG tests for Neisseria gonorrhoeae

被引:108
作者
Martin, DH
Cammarata, C
van der Pol, B
Jones, RB
Quinn, TC
Gaydos, CA
Crotchfelt, K
Schachter, J
Moncada, J
Jungkind, D
Turner, B
Peyton, C
机构
[1] Louisiana State Univ, Med Ctr, Dept Internal Med, New Orleans, LA 70118 USA
[2] City New Orleans Delgado Clin, New Orleans, LA USA
[3] Indiana Univ, Sch Med, Indianapolis, IN USA
[4] NIAID, NIH, Bethesda, MD 20892 USA
[5] Johns Hopkins Univ, Baltimore, MD USA
[6] Univ Calif San Francisco, San Francisco, CA 94143 USA
[7] Thomas Jefferson Univ Hosp, Pittsburgh, PA USA
[8] Univ Texas, Med Branch, Galveston, TX 77550 USA
关键词
D O I
10.1128/JCM.38.10.3544-3549.2000
中图分类号
Q93 [微生物学];
学科分类号
071005 ; 100705 ;
摘要
The fully automated COBAS AMPLICOR CT/NG and semiautomated AMPLICOR CT/NG; tests were evaluated in a multicenter trial for their ability to detect Neisseria gonorrhoeae infections, Test performance compared to that of culturing was evaluated for 2,192 matched endocervical swab and urine specimens obtained From women and for 1,981 matched urethral swab and urine specimens obtained from men. Culture-negative, PCR-positive specimens that tested positive in a confirmatory PCR test for an alternative target sequence within the N. gonorrhoeae 16S rRNA gene were considered to be true positives. The overall prevalences of gonorrhea were 6.6% in women and 20.1% in men. The COBAS AMPLICOR and AMPLICOR formats yielded concordant results for 98.8% of the specimens and exhibited virtually identical sensitivities and specificities. The results that follow are for the COBAS AMPLICOR format. With the infected patient as the reference standard, the resolved sensitivities of PCR were 92.4% for endocervical swab specimens and 64.8% for female urine specimens. There were no significant differences in these rates between women with and without symptoms, Among symptomatic men, COBAS AMPLICOR sensitivities were 94.1% for urine and 98.1% for urethral swabs; for asymptomatic men, the results were 42.3 and 73.1%, respectively, In comparison, the sensitivities of culturing were 84.8% for endocervical specimens, 92.7% for symptomatic male urethral specimens, and only 46.2% for urethral specimens obtained from asymptomatic men. When PCR results were analyzed as if only a single test had been performed on a single specimen type, the resolved sensitivity,ias always higher. The resolved specificities of PCR were 99.5% for endocervical swab specimens, 99.8% for female urine specimens, 98.9% for male urethral swab specimens, and 99.9% for male urine specimens. The internal control revealed that 2.1% of specimens were inhibitory when initially tested. Nevertheless, valid results were obtained for 99.2% of specimens because 60.0% of the inhibitory specimens were not inhibitory when a second aliquot was tested. The COBAS AMPLICOR CT/NG test for N. gonorrhoeae exhibited high sensitivity and specificity with urethral swab and urine specimens from men and endocervical swab specimens from women and thus is well suited for diagnosing and screening for N, gonorrhoeae infection.
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页码:3544 / 3549
页数:6
相关论文
共 20 条
[1]   ASSOCIATION OF RECURRENT CHLAMYDIAL INFECTION WITH GONORRHEA [J].
BATTEIGER, BE ;
FRAIZ, J ;
NEWHALL, WJ ;
KATZ, BP ;
JONES, RB .
JOURNAL OF INFECTIOUS DISEASES, 1989, 159 (04) :661-669
[2]   Screening for gonorrhea and Chlamydia by DNA amplification in adolescents attending middle school health centers - Opportunity for early intervention [J].
Burstein, GR ;
Waterfield, G ;
Joffe, A ;
Zenilman, JM ;
Quinn, TC ;
Gaydos, CA .
SEXUALLY TRANSMITTED DISEASES, 1998, 25 (08) :395-402
[3]   Evaluation of the Abbott LCx ligase chain reaction assay for detection of Chlamydia trachomatis and Neisseria gonorrhoeae in urine and genital swab specimens from a sexually transmitted disease clinic population [J].
Carroll, KC ;
Aldeen, WE ;
Morrison, M ;
Anderson, R ;
Lee, D ;
Mottice, S .
JOURNAL OF CLINICAL MICROBIOLOGY, 1998, 36 (06) :1630-1633
[4]   LIGASE CHAIN-REACTION FOR DETECTION OF NEISSERIA-GONORRHOEAE IN UROGENITAL SWABS [J].
CHING, SF ;
LEE, H ;
HOOK, EW ;
JACOBS, MR ;
ZENILMAN, J .
JOURNAL OF CLINICAL MICROBIOLOGY, 1995, 33 (12) :3111-3114
[5]   Evaluation of AMPLICOR Neisseria gonorrhoeae PCR using cppB nested PCR and 16S rRNA PCR [J].
Farrell, DJ .
JOURNAL OF CLINICAL MICROBIOLOGY, 1999, 37 (02) :386-390
[6]   Gonorrhea in the United States, 1981-1996 - Demographic and geographic trends [J].
Fox, KK ;
Whittington, WL ;
Levine, WC ;
Moran, JS ;
Zaidi, AA ;
Nakashima, AK .
SEXUALLY TRANSMITTED DISEASES, 1998, 25 (07) :386-393
[7]   Comparison of three commercially available amplification assays, AMP CT, LCx, and COBAS AMPLICOR, for detection of Chlamydia trachomatis in first-void urine [J].
Goessens, WHF ;
Mouton, JW ;
vanderMeijden, WI ;
Deelen, S ;
vanRijsoortVos, TH ;
Toom, NLD ;
Verbrugh, HA ;
Verkooyen, RP .
JOURNAL OF CLINICAL MICROBIOLOGY, 1997, 35 (10) :2628-2633
[8]   Diagnosis of Neisseria gonorrhoeae infections in women by using the ligase chain reaction on patient-obtained vaginal swabs [J].
Hook, EW ;
Ching, SF ;
Stephens, J ;
Hardy, KF ;
Smith, KR ;
Lee, HH .
JOURNAL OF CLINICAL MICROBIOLOGY, 1997, 35 (08) :2129-2132
[9]  
HOOK EW, 1990, SEXUALLY TRANSMITTED, P149
[10]   Evaluation of the Abbott LCx assay for detection of Neisseria gonorrhoeae in endocervical swab specimens from females [J].
Kehl, SC ;
Georgakas, K ;
Swain, GR ;
Sedmak, G ;
Gradus, S ;
Singh, A ;
Foldy, S .
JOURNAL OF CLINICAL MICROBIOLOGY, 1998, 36 (12) :3549-3551