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Background
This sexually transmitted disease is still terrorizing patients of all ages.
OUTLINE
Epidemiology Disease Associations Laboratory/Radiologic/Other Diagnostic Testing Prognosis and Treatment Commonly Used Terms
EPIDEMIOLOGY CHARACTERIZATION SYNONYMS INCIDENCE Prevalence of chlamydial and gonococcal infections among young adults in the United States.
Miller WC, Ford CA, Morris M, Handcock MS, Schmitz JL, Hobbs MM, Cohen MS, Harris KM, Udry JR.
Department of Medicine, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill 27599-7435, USA
JAMA. 2004 May 12;291(18):2229-36. Abstract quote
CONTEXT: Chlamydial and gonococcal infections are important causes of pelvic inflammatory disease, ectopic pregnancy, and infertility. Although screening for Chlamydia trachomatis is widely recommended among young adult women, little information is available regarding the prevalence of chlamydial and gonococcal infections in the general young adult population.
OBJECTIVE: To determine the prevalence of chlamydial and gonococcal infections in a nationally representative sample of young adults living in the United States.
DESIGN, SETTING, AND PARTICIPANTS: Cross-sectional analyses of a prospective cohort study of a nationally representative sample of 14,322 young adults aged 18 to 26 years. In-home interviews were conducted across the United States for Wave III of The National Longitudinal Study of Adolescent Health (Add Health) from April 2, 2001, to May 9, 2002. This study sample represented 66.3% of the original 18,924 participants in Wave I of Add Health. First-void urine specimens using ligase chain reaction assay were available for 12,548 (87.6%) of the Wave III participants.
MAIN OUTCOME MEASURES: Prevalences of chlamydial and gonococcal infections in the general young adult population, and by age, self-reported race/ethnicity, and geographic region of current residence.
RESULTS: Overall prevalence of chlamydial infection was 4.19% (95% confidence interval [CI], 3.48%-4.90%). Women (4.74%; 95% CI, 3.93%-5.71%) were more likely to be infected than men (3.67%; 95% CI, 2.93%-4.58%; prevalence ratio, 1.29; 95% CI, 1.03-1.63). The prevalence of chlamydial infection was highest among black women (13.95%; 95% CI, 11.25%-17.18%) and black men (11.12%; 95% CI, 8.51%-14.42%); lowest prevalences were among Asian men (1.14%; 95% CI, 0.40%-3.21%), white men (1.38%; 95% CI, 0.93%-2.03%), and white women (2.52%; 95% CI, 1.90%-3.34%). Prevalence of chlamydial infection was highest in the south (5.39%; 95% CI, 4.24%-6.83%) and lowest in the northeast (2.39%; 95% CI, 1.56%-3.65%). Overall prevalence of gonorrhea was 0.43% (95% CI, 0.29%-0.63%). Among black men and women, the prevalence was 2.13% (95% CI, 1.46%-3.10%) and among white young adults, 0.10% (95% CI, 0.03%-0.27%). Prevalence of coinfection with both chlamydial and gonococcal infections was 0.030% (95% CI, 0.18%-0.49%).
CONCLUSIONS: The prevalence of chlamydial infection is high among young adults in the United States. Substantial racial/ethnic disparities are present in the prevalence of both chlamydial and gonococcal infections.AGE RANGE-MEDIAN
Gonorrhea and chlamydia screening among young women: stage of change, decisional balance, and self-efficacy.Banikarim C, Chacko MR, Wiemann CM, Smith PB.
Eric Williams Science Medical Center, Department of Pediatrics, West Indies (C.B.), Trincity, Trinidad
J Adolesc Health 2003 Apr;32(4):288-95 Related Articles, Links
Gonorrhea and chlamydia screening among young women: stage of change, decisional balance, and self-efficacy.Banikarim C, Chacko MR, Wiemann CM, Smith PB.
Eric Williams Science Medical Center, Department of Pediatrics, West Indies (C.B.), Trincity, Trinidad
To assess perceived sexually transmitted disease (STD) (gonorrhea and chlamdydia) screening behaviors among young women at risk for STDs by evaluating readiness, pros and cons, and self-efficacy to seek STD screening in the absence of symptoms.Two hundred forty young urban women (mean 18.8 years +/-1.59) consecutively attending an urban reproductive clinic voluntarily completed a 67-item questionnaire on STD screening behaviors that included the stages of change (SOCs), decisional balance, and self-efficacy as well as sexual practices and partner relationships. The data were analyzed using descriptive statistics, multivariate analyses of variance, Chi-square tests, and Wilcoxon signed rank test.Ninety-five percent of the participants would be willing to obtain STD screening for early disease detection. Participants were further along the SOCs for STD screening following unprotected sex with a change in partner than main partner, (p <.001). Pros and cons of STD screening varied according to the SOCs for STD screening with a change in partner and main partner. Self-efficacy increased linearly along the SOCs for STD screening (p <.001).
Most young women recognize the importance of STD screening but are not currently being tested when at risk for STDs. STD screening behaviors varied according to the partner relationship, which highlights the importance of stage- and partner-matched counseling to promote STD screening particularly when at risk for STDs.
GEOGRAPHY
DISEASE ASSOCIATIONS CHARACTERIZATION CHLAMYDIA
Co-infection with gonorrhoea and chlamydia: how much is there and what does it mean?Creighton S, Tenant-Flowers M, Taylor CB, Miller R, Low N.
MRC Health Service Research Collaboration, Department of Social Medicine, University of Bristol, Canynge Hall, Whiteladies Road, Bristol BS8 2PR, UK.
Int J STD AIDS 2003 Feb;14(2):109-13 Abstract quote A cross-sectional study of new clients with either gonorrhoea or chlamydia attending King's College Hospital in 1998. One thousand two hundred and thirty-nine women and 1141 men had gonorrhoea, chlamydia or both. Overall, 24.2% (124/512) of heterosexual men and 38.5% (136/353) of women with gonorrhoea also had chlamydia (P<0.001).
Of heterosexual males 18.8% (124/660) and 13% (136/1022) of females with chlamydia also had gonorrhoea (P=0.002). Ethnicity had no effect on the proportion of co-infection after controlling for age and gender. Clients with dual infection were younger than those with either infection alone (P=0.0001). Over half of women and a quarter of men aged 15 to 19 years were dually infected so testing for both gonorrhoea and chlamydia may be appropriate in this age group in settings outside genitourinary clinics.
The high proportion of cases of gonorrhoea that also have chlamydia justifies the policy of epidemiological treatment for chlamydia.
PREVENTION
Prevention of sexually transmitted diseases (STDs) in female sex workers: prospective evaluation of condom promotion and strengthened STD services.Sanchez J, Campos PE, Courtois B, Gutierrez L, Carrillo C, Alarcon J, Gotuzzo E, Hughes J, Watts D, Hillier SL, Buchanan K, Holmes KK.
Center for AIDS and STD, University of Washington, Seattle, Washington 98104, USA.
Sex Transm Dis 2003 Apr;30(4):273-9 Abstract quote BACKGROUND: In Peru, a previous study of government-sponsored periodic examinations of female sex workers (FSWs) found no significant impact on rates of sexually transmitted diseases (STDs).
GOAL: This study assessed the impact of technically improved periodic STD services on STD prevalence and on consistent condom use (CCU).
STUDY DESIGN: The study involved monthly follow-up of 917 FSWs at two STD clinics, with evaluations before and during implementation of strengthened STD services, which included periodic screening and treatment for gonorrhea, chlamydial infection, trichomoniasis, bacterial vaginosis (BV), and syphilis; counseling; and supply of condoms. Outcome analyses were adjusted for participation bias.
RESULTS: During 7908 person-months of observation, the prevalences of gonorrhea, chlamydial infection, trichomoniasis, and BV declined significantly and CCU increased significantly, with similar trends in both clinics. During follow-up, gonorrhea, chlamydial infection, trichomoniasis, and BV were negatively associated with follow-up after screening. BV also was positively associated with use of an intrauterine device and negatively with douching. CCU during follow-up was associated with significantly decreased risk of gonorrhea, chlamydial infection, and trichomoniasis.
CONCLUSIONS: Strengthened periodic screening for and treatment of confirmed STD, in addition to condom promotion and provision, represent feasible, effective interventions in commercial sex, and time series analyses can provide a useful approach to evaluating new interventions.
LABORATORY/
RADIOLOGIC/
OTHER TESTSCHARACTERIZATION Evaluation of Urine Specimen Integrity in a Public Health STD Screening Program
Nathan C. Birch, MD
Douglas F. Stickle, PhD
Anita Young
Philip Medina
and Steven H. Hinrichs, MDAm J Clin Pathol 2003;119:516-521 Abstract quote
Detection of Chlamydia trachomatis and/or Neisseria gonorrhoeae infection in urine using molecular amplification assays has permitted institutions with limited medical facilities to offer testing for these sexually transmitted diseases (STDs).The Nebraska Public Health Laboratory (NPHL) investigated the validity of urine samples submitted for C trachomatis and/or N gonorrhoeae amplification after receiving a substantial number of clear specimens. Approximately 75% of all urine specimens submitted for STD testing to the NPHL were from correctional facilities. The falsification of urine specimens submitted for microbiology studies is not evaluated routinely, and this problem was previously undocumented.
By using the criteria for specific gravity of 1.001 or less and a creatinine concentration of less than 5 mg/dL (442 µmol/L), approximately 8% of all specimens submitted during the study interval were determined to be inconsistent with urine. The microbiology laboratory should be aware of the possibility for specimen manipulation to identify facilities submitting falsified specimens, to initiate appropriate intervention, and to minimize false-negative reporting.
CULTURE Culture in McCoy cells-current reference method for C. trachomatis DNA HYBRIDIZATION/SIGNAL AMPLIFICATION DIGENE
Comparison of Digene Hybrid Capture 2 and Conventional Culture for Detection of Chlamydia trachomatis and Neisseria gonorrhoeae in Cervical Specimens.Darwin LH, Cullen AP, Arthur PM, Long CD, Smith KR, Girdner JL, Hook III EW, Quinn TC, Lorincz AT.
Digene Corporation, Gaithersburg, Maryland 20878. University of Alabama at Birmingham, Birmingham, Alabama 35294. Johns Hopkins University, Baltimore, Maryland 21205.
J Clin Microbiol 2002 Feb;40(2):641-4 Abstract quote Digene's Hybrid Capture 2 (HC2) CT/GC, CT-ID, and GC-ID DNA tests were evaluated by comparison to traditional culture methods for detecting Chlamydia trachomatis and Neisseria gonorrhoeae infections in 669 cervical specimens from high-risk female populations attending two sexually transmitted disease clinics.
For detection of either or both infections, the HC2 CT/GC test algorithm had 93.8% sensitivity and 95.9% specificity compared to those of culture. After resolution of discrepant results by direct fluorescent-antibody (DFA) staining or PCR assay, the relative sensitivity and specificity of the HC2 CT/GC test algorithm increased to 94.8 and 99.8%, while the values for culture were 83.6% (McNemar's P value, 0.0062) and 100%, respectively.
For detection of the individual pathogens, the relative sensitivities for the HC2 CT-ID and GC-ID tests were 97.2 and 92.2% and the specificities were greater than 99% compared to culture adjucated by DFA staining and PCR. Test performance varied at the two clinics: the HC2 CT/GC algorithm, CT-ID, and GC-ID tests had significantly higher sensitivities (McNemar's P value, <0.05) than that of culture for the population at one clinic as well as for the combined populations. At the other clinic, the HC2 tests performed as well as culture.
Evaluation of the digene hybrid capture II CT-ID test for detection of Chlamydia trachomatis in endocervical specimens.Girdner JL, Cullen AP, Salama TG, He L, Lorincz A, Quinn TC.
Division of Infectious Diseases, The Johns Hopkins University, Baltimore, Maryland 21205, USA.
J Clin Microbiol 1999 May;37(5):1579-81 Abstract quote The performance characteristics of the new signal amplification-based Hybrid Capture (HC) II CT-ID test system (Digene, Silver Spring, Md.) with endocervical specimens were compared to those of tissue culture and PCR (AMPLICOR CT PCR; Roche Molecular Systems, Branchburg, N.J.) for detection of Chlamydia trachomatis in 587 women. HC II CT-ID identified 62 of 65 confirmed C. trachomatis-positive patients (sensitivity of 95.4%) and was negative for 517 of 522 patients who were negative by culture and PCR (specificity of 99.0%). Twelve of the 65 confirmed positive patients were negative by culture but were identified by both HC II CT-ID and PCR (sensitivity of culture was 81.5% [P < 0.01]). In comparison, PCR detected 59 of 65 positive specimens (sensitivity of 90.8%) and had a specificity of 99.6% (520 of 522). These results demonstrate that the Digene HC II CT-ID test is a highly sensitive and specific assay for the detection of C. trachomatis infection in endocervical specimens.
Detection of Chlamydia trachomatis and Neisseria gonorrhoeae in swab specimens by the Hybrid Capture II and PACE 2 nucleic acid probe tests.Modarress KJ, Cullen AP, Jaffurs WJ Sr, Troutman GL, Mousavi N, Hubbard RA, Henderson S, Lorincz AT.
Digene Corporation, Silver Spring, Maryland 20904, USA.
Sex Transm Dis 1999 May;26(5):303-8 Abstract quote BACKGROUND AND OBJECTIVES: The Digene Hybrid Capture II (HC II) CT/GC Test (Digene Corp., Beltsville, MD) is a new nucleic acid signal amplification-based test for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae in specimens from the genital tract. For optimal results, the HC II CT/GC Test employs a special conical shaped brush for cervical specimen collection from nonpregnant women and swabs from pregnant women. GOALS: To validate a protocol for HC II C. trachomatis and N. gonorrhoeae testing of specimens collected for the GenProbe PACE 2 System.
STUDY DESIGN: Specimens were collected from 1,746 patients with a swab and placed in GenProbe transport media according to the manufacturer's recommended procedure. The specimens were first tested at two clinical laboratories by the PACE 2 system, and then blindly tested by HC II CT/GC using an adjusted cutoff value. Discrepant specimens were adjudicated by polymerase chain reaction (PCR), and the result common to two of the three testing methods (HC II, PACE 2, and PCR) was defined as the consensus result.
RESULTS: Combining the data from both sites, the relative sensitivity of the HC II Test compared with the consensus result for the detection of 1,761 specimens for C. trachomatis and 1,750 specimens for N. gonorrhoeae was 100% for both organisms. The relative specificities for C. trachomatis and N. gonorrhoeae detection were 99.8% and 99.7%, respectively. The relative sensitivities of the PACE 2 CT and GC Systems were 86.5% and 87.1%, respectively, with relative specificities of 99.9% and 100%. The difference in sensitivity between HC II and PACE 2 for C. trachomatis detection was significant (P < 0.016).
CONCLUSION: The HC II CT/GC Test can be performed using specimens collected in GenProbe transport media and has a significantly greater sensitivity for C. trachomatis detection than the PACE 2 System.
Ability of the digene hybrid capture II test to identify Chlamydia trachomatis and Neisseria gonorrhoeae in cervical specimens.Schachter J, Hook EW 3rd, McCormack WM, Quinn TC, Chernesky M, Chong S, Girdner JI, Dixon PB, DeMeo L, Williams E, Cullen A, Lorincz A.
Chlamydia Research Laboratory, Department of Laboratory Medicine, University of California, San Francisco, San Francisco, California 94110, USA.
J Clin Microbiol 1999 Nov;37(11):3668-71 Abstract quote The Digene Hybrid Capture II (HCII CT/GC) test is a combination test designed to detect Chlamydia trachomatis and Neisseria gonorrhoeae in a single specimen. It is a nucleic acid hybridization test which uses signal amplification to increase sensitivity.
We compared its performance to that of culture on cervical specimens from 1,370 women. Direct fluorescent-antibody assay was used to resolve discrepant results for C. trachomatis. Samples were collected with a proprietary cervical brush or with endocervical swabs. The HCII CT/GC test proved to be sensitive and specific in detecting these organisms.
Compared to N. gonorrhoeae culture, it had a sensitivity of 93% (87/94) and a specificity of 98.5% (1,244/1,263). Compared to C. trachomatis culture, the sensitivity was 97.7% (129/132) and specificity was 98.2% (1,216/1,238). Testing of some specimens with discrepant results by PCR suggested that the test would actually prove to be even more specific if it were compared to a nucleic acid amplification test (NAAT). The sensitivity of C. trachomatis culture was somewhat less, at 88.6% (117/132). The endocervical brush appeared to be better than Dacron swabs for collecting specimens. The HCII CT/GC test offers an attractive format that allows simultaneous detection of C. trachomatis and N. gonorrhoeae with a single specimen. An initial positive result is followed by repeat tests with probes to identify chlamydiae or gonococci.
This test is more sensitive than C. trachomatis culture and is at least as sensitive as culture for gonococci. It deserves further evaluation and comparison with NAATs and may well offer an attractive alternative for diagnosis and screening of these infections.
ABBOT LCX
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.Carroll KC, Aldeen WE, Morrison M, Anderson R, Lee D, Mottice S.
Department of Pathology, University of Utah Health Sciences Center, Salt Lake City 84132, USA.
J Clin Microbiol 1998 Jun;36(6):1630-3 Abstract quote The Abbott LCx ligase chain reaction (LCR) assay for the simultaneous detection of Chlamydia trachomatis and Neisseria gonorrhoeae was evaluated by using swab and urine specimens from 562 patients. C. trachomatis results by LCR were compared to those by the Gen-Probe PACE 2 assay, whereas N. gonorrhoeae results by LCR were compared to those by culture. The Gen-Probe and LCR assays were performed according to the manufacturers' instructions. Gram-negative diplococci growing on modified Thayer-Martin medium were confirmed as N. gonorrhoeae by the GonoGen II assay. Supplemental data analysis was performed by major outer membrane protein PCR for C. trachomatis and probes for pilin gene detection for N. gonorrhoeae. A true-positive result for each pathogen was defined as a positive result for all three or two of three assays.
Overall agreement among the six assays was 94.8%. C. trachomatis prevalence was 16.2%; N. gonorrhoeae prevalence was 5.5%. The overall sensitivity and specificity, respectively, for each test (after supplemental data analysis) were as follows: for C. trachomatis, Gen-Probe, 65.9 and 100%; LCR on urine, 90.1 and 100%; LCR on swab specimens, 96.7 and 100%; and for N. gonorrhoeae, culture, 80.6 and 100%; LCR on urine, 93.5 and 99.8%; and LCR on swab specimens, 96.8 and 100%. For women, the N. gonorrhoeae culture was very insensitive compared to its performance in men (58.3 versus 94.7%, respectively).
For C. trachomatis, the Gen-Probe assay's sensitivity was lower for men than for women (62.3 versus 71.1%, respectively). The sensitivity for C. trachomatis detection by LCR on urethral and cervical swab specimens was 96.2 and 97.4% for men and women, respectively. For men, swab results were slightly better than urine results for both pathogens (sensitivity for C. trachomatis in swab and urine specimens, 96.2 and 92.5%, respectively; sensitivity for N. gonorrhoeae in swab and urine specimens, 100 and 94.7%, respectively), while for women, cervical swabs were superior in sensitivity to urine samples for detecting C. trachomatis (swab, 97.4%; urine, 81.6%) and equivalent for N. gonorrhoeae (swab, 92.3%; urine, 91.6%). The LCx LCR appears to be both sensitive and specific for the detection of C. trachomatis and N. gonorrhoeae when performed on urine or genital swab samples. Swab samples had better sensitivity than urine samples for the detection of both pathogens.
BD PROBETEC
Strand displacement amplification and homogeneous real-time detection incorporated in a second-generation DNA probe system, BDProbeTecET.Little MC, Andrews J, Moore R, Bustos S, Jones L, Embres C, Durmowicz G, Harris J, Berger D, Yanson K, Rostkowski C, Yursis D, Price J, Fort T, Walters A, Collis M, Llorin O, Wood J, Failing F, O'Keefe C, Scrivens B, Pope B, Hansen T, Marino K, Williams K, et al.
Becton Dickinson Microbiology Systems, 54 Loveton Circle, Sparks, MD 21152, USA.
Clin Chem 1999 Jun;45(6 Pt 1):777-84 Abstract quote BACKGROUND: Amplified DNA probes provide powerful tools for the detection of infectious diseases, cancer, and genetic diseases. Commercially available amplification systems suffer from low throughput and require decontamination schemes, significant hands-on time, and specially trained laboratory staff. Our objective was to develop a DNA probe system to overcome these limitations.
METHODS: We developed a DNA probe system, the BDProbeTecTMET, based on simultaneous strand displacement amplification and real-time fluorescence detection. The system uses sealed microwells to minimize the release of amplicons to the environment. To avoid the need for specially trained labor, the system uses a simple workflow with predispensed reagent devices; a programmable, expandable-spacing pipettor; and the 96-microwell format. Amplification and detection time was 1 h, with potential throughput up to 564 patient results per shift. We tested 122 total patient specimens obtained from a family practice clinic with the BD ProbeTecET and the Abbott LCx(R) amplified system for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae.
Results: Based on reportable results, the BDProbeTecET results for both organisms were 100% sensitive and 100% specific relative to the LCx.
Conclusions: The BDProbeTecET is an easy-to-use, high-throughput, closed amplification system for the detection of nucleic acid from C. trachomatis and N. gonorrhoeae and other organisms.
Performance characteristics of the Becton Dickinson ProbeTec System for direct detection of Chlamydia trachomatis and Neisseria gonorrhoeae in male and female urine specimens in comparison with the Roche Cobas System.Chan EL, Brandt K, Olienus K, Antonishyn N, Horsman GB.
Virology Section, Department of Clinical Microbiology, Provincial Laboratory, Regina, Saskatchewan, Canada.
Arch Pathol Lab Med 2000 Nov;124(11):1649-52 Abstract quote OBJECTIVE: The Becton Dickinson BDProbeTec ET System is a new semiautomated system using strand displacement amplification technology that simultaneously amplifies and detects Chlamydia trachomatis and Neisseria gonorrhoeae DNA. The strand displacement amplification products are hybridized with a fluorescent detector probe and are captured by a chemiluminescent assay in a microwell format. An amplification control is also included to monitor assay inhibition. This study evaluated the performance of the BDProbTec ET system in detecting C trachomatis and N gonorrhoeae in male and female urine specimens, calculated its ability to process large volumes of specimens, and determined the inhibition rate.
MATERIALS AND METHODS: Eight hundred twenty-five male and 399 female urine specimens were tested for both C trachomatis and N gonorrhoeae with the BDProbeTec ET system, and results were compared with those of the Roche Amplicor Cobas system. All urine specimens were processed on both assays on the same day they were received, according to the manufacturers' instructions. Discrepant results were resolved by in-house polymerase chain reaction assays. Internal or amplification controls were also used in each specimen assay to monitor inhibition. The throughput of the BDProbTec ET system was further tested with 150 urine specimens on an 8-hour shift for 2 days.
RESULTS: The overall sensitivity, specificity, positive predicative value, and negative predicative value for for detection of chlamydia were 95.3%, 99.3%, 95.9%, and 99.2% for strand displacement amplification and 95.9%, 98.3%, 90.6%, and 99.3% for the Roche Amplicor system. For detection of gonorrhea, these values were 100%, 99.7%, 88.2%, and 100% and 96.7%, 98.9%, 69%, and 99.9%, respectively. The overall inhibition rates for both strand displacement amplification and Roche Amplicor were less than 3.5%. The BDProbTec ET system was able to produce 150 results each for chlamydia and gonorrhea and the internal control within the 8-hour shift.
CONCLUSIONS: The performance characteristics of the BDProbeTec ET assay are similar to those of the Roche Amplicor polymerase chain reaction for detection of chlamydia and gonorrhea in male and female urine specimens. The system was able to produce 300 results in an 8-hour shift.
Multicenter evaluation of the BDProbeTec ET System for detection of Chlamydia trachomatis and Neisseria gonorrhoeae in urine specimens, female endocervical swabs, and male urethral swabs.Van Der Pol B, Ferrero DV, Buck-Barrington L, Hook E 3rd, Lenderman C, Quinn T, Gaydos CA, Lovchik J, Schachter J, Moncada J, Hall G, Tuohy MJ, Jones RB.
Indiana University School of Medicine, Indianapolis, IN 46202, USA.
J Clin Microbiol 2001 Mar;39(3):1008-16 Abstract quote The performance of the Becton Dickinson BDProbe Tec ET System Chlamydia trachomatis and Neisseria gonorrhoeae Amplified DNA Assays (BD Biosciences, Sparks, Md.) was evaluated in a multicenter study.
Specimens were collected from 2,109 men and women, with or without symptoms, attending sexually transmitted disease, family planning, and obstetrics and gynecology clinics. Both swab and urine samples were collected, and the results obtained from 4,131 specimens were compared to those from culture and the LCx nucleic acid amplification test (Abbott Industries, Abbott Park, Ill.). PCR and cytospin of the culture transport medium with chlamydia direct fluorescent antibody staining were used to adjudicate chlamydia culture-negative results. Sensitivity and specificity were calculated both with and without use of the amplification control (AC), with little apparent difference in the results. Without the AC result, sensitivity for C. trachomatis and N. gonorrhoeae were 92.8 and 96.6%, respectively, for cervical swabs and 80.5 and 84.9% for urine from women. C. trachomatis and N. gonorrhoeae sensitivities were 92.5 and 98.5%, respectively, for male urethral swabs and 93.1 and 97.9% for urine from men.
This amplified DNA system for simultaneous detection of chlamydial and gonococcal infections demonstrated superior sensitivity compared to chlamydia culture and has performance characteristics comparable to those of other commercially available nucleic acid-based assays for these organisms.
Screening for Chlamydia trachomatis infection using the BDProbeTec ET Chlamydia trachomatis amplified DNA assay on urine in a GUM clinic setting: a simple, fast and cost-effective alternative.Browning MR, Corden S, Mitchell B, Westmoreland D.
Department of Genitourinary Medicine, West Wing Hospital (Cardiff Royal Infirmary), Newport Road, Cardiff CF24 0SZ, UK.
Int J STD AIDS 2001 Jul;12(7):430-6 Abstract quote This study compared the BDProbeTec ET Chlamydia trachomatis amplified DNA assay on urine specimens with culture of genital swabs for the detection of C. trachomatis in patients attending the Department of Genitourinary Medicine (GUM), Cardiff Royal Infirmary. Almost twice as many patients tested positive by BDProbeTec ET than by culture.
A similar difference was found for both males and females. The case notes of those patients positive by BDProbeTec ET alone were analysed and a significantly greater number were found to have risk indicators for C. trachomatis infection when compared with age and sex comparable controls, providing clinical validation of our findings. The BDProbeTec ET assay was easy to use, more importantly, the test format features an internal control integral with every sample. The cost per true positive was calculated as comparable with culture.
We conclude that the BDProbeTec ET assay is a superior alternative to culture for identifying patients infected with C. trachomatis in the GUM clinic setting.
Evaluation of a strand displacement amplification assay (BD ProbeTec-SDA) for detection of Neisseria gonorrhoeae in urine specimens.Akduman D, Ehret JM, Messina K, Ragsdale S, Judson FN.
Denver Public Health Department, Denver, Colorado 80204-4507, USA.
J Clin Microbiol 2002 Jan;40(1):281-3 Abstract quote The performance of a strand displacement amplification assay (the BDProbeTec-SDA assay) in detecting Neisseria gonorrhoeae in urine specimens was evaluated.
When performed under stringent quality control conditions, the BDProbeTec-SDA assay is a sensitive, specific, and efficient method for the screening of large numbers of noninvasively obtained specimens.
Because the predictive value of an assay is a function of the prevalence of the disease, culture confirmation is needed for samples with positive results from populations in which the prevalence of a disease is low or in situations in which false-positive results may have important medical, psychosocial, or medicolegal consequences.
COBAS AMPLIACOR
Evaluation of COBAS AMPLICOR (Roche): accuracy in detection of Chlamydia trachomatis and Neisseria gonorrhoeae by coamplification of endocervical specimens.Livengood CH 3rd, Wrenn JW.
Chlamydia Laboratory, Duke University Medical Center, Durham, North Carolina, USA.
J Clin Microbiol 2001 Aug;39(8):2928-32 Abstract quote We evaluated further the accuracy of the COBAS AMPLICOR (Roche) (CA) PCR-based system in detection of Chlamydia trachomatis and Neisseria gonorrhoeae in endocervical specimens. Endocervical specimens collected for any indication for testing for C. trachomatis and N. gonorrhoeae among a university hospital health system population were included.
Testing for C. trachomatis was done by two PCR methods, CA and manual microwell AMPLICOR (Roche) (MWA), and by culture; testing for N. gonorrhoeae was done by CA and culture. Discrepancy resolution was performed. Reproducibility testing and hands-on labor time measurements for CA were done. Among 654 C. trachomatis samples, the prevalence of true positivity was 9.2%, and among the 618 N. gonorrhoeae samples, the prevalence of true positivity was 4.4%. For detection of C. trachomatis, the sensitivity, specificity, and negative and positive predictive values were, respectively, as follows for each test: CA, 93.3, 99.7, 99.3, and 96.4%; MWA, 91.7, 99.7, 99.2, and 96.5%; and culture, 65.0, 100, 96.6, and 100%. For detection of N. gonorrhoeae those values were as follows: CA, 96.3, 100, 99.8, and 100%; and culture, 92.6, 100, 99.7, and 100%. Hands-on labor time for each clinical result was estimated to be at 7.5 min. The prevalence of inhibitory specimens was 3.5%, including two positive C. trachomatis samples which would have been missed otherwise. The direct cost of each clinical result with CA was estimated to be $9.09.
Our methods include a diverse range of indications for testing among women, using endocervical swabbing samples, 2 M sucrose phosphate transport medium, and discrepancy resolution for comparison. Under our test conditions, the CA system is an accurate, rapid, and cost- and labor-efficient method for detection of C. trachomatis and N. gonorrhoeae.
GEN PROBE
A comparative study for detection of Chlamydia trachomatis and Neisseria gonorrhoeae with DNA probe (a note).Szell A, Tisza T, Horvath A.
Department of Dermato-Venereology, Semmelweis University School of Medicine, Budapest, Hungary.
Acta Microbiol Immunol Hung 1994;41(3):291-3 Abstract quote A newly developed DNA probe assay (Gen-Probe Pace 2 San Diego, USA) was compared with Chlamydia trachomatis direct immunofluorescence and Neisseria gonorrhoeae culture. Detection of C. trachomatis in cervical specimens from women and urethral specimens from men showed 23% positivity out of 313 cases.
Out of the 69 positive cases 40 were positive with both examinations, in 29 cases only with DNA probe. Examinations of N. gonorrhoeae in 254 patients gave 98% positivity. Sensitivity of DNA probe assay was 100%, specificity was 97.8%.
On the basis of preliminary data Gen-Probe is suitable for the detection of both causative agents.
Evaluation of nucleic acid-based test (PACE 2C) for simultaneous detection of Chlamydia trachomatis and Neisseria gonorrhoeae in endocervical specimens.Iwen PC, Walker RA, Warren KL, Kelly DM, Hinrichs SH, Linder J.
Department of Pathology and Microbiology, University of Nebraska Medical Center, Omaha, USA.
J Clin Microbiol 1995 Oct;33(10):2587-91 Abstract quote A nucleic acid-based test (Gen-Probe PACE 2C System) was evaluated for the ability to detect Chlamydia trachomatis and Neisseria gonorrhoeae from endocervical specimens in a single assay.
Three swab samples, randomized for collection order, were obtained from each patient and tested by N. gonorrhoeae and C. trachomatis culture and by the PACE 2C probe assay. Fifty of 395 specimens were culture positive for N. gonorrhoeae (17 specimens), C. trachomatis (26 specimens), or both (7 specimens), of which PACE 2C testing detected 48 specimens. The PACE 2C assay was positive for 56 specimens, including 8 specimens not positive by culture. Of the total of 10 discrepancies between culture and PACE 2C results, resolution testing yielded four false-negative culture, four false-positive PACE 2C, and two false-negative PACE 2C results. The sensitivity, specificity, and positive and negative predictive values for PACE 2C after reevaluation were 96.3, 98.8, 92.9 and 99.4%, respectively. The overall sensitivities for C. trachomatis and N. gonorrhoeae culture were 89.2 and 88.9%, respectively. The prevalence rate for C. trachomatis was 9.4%, and that for N. gonorrhoeae was 6.8%.
The Gen-Probe PACE 2C System is a reliable alternative for screening endocervical specimens for both C. trachomatis and N. gonorrhoeae in a single assay.
Performance of the Gen-Probe AMPLIFIED Chlamydia Trachomatis Assay in detecting Chlamydia trachomatis in endocervical and urine specimens from women and urethral and urine specimens from men attending sexually transmitted disease and family planning clinics.Ferrero DV, Meyers HN, Schultz DE, Willis SA.
San Joaquin County Regional Public Health Laboratory, Stockton, California, USA.
J Clin Microbiol 1998 Nov;36(11):3230-3 Abstract quote The Gen-Probe AMPLIFIED Chlamydia Trachomatis Assay (AMP CT) uses transcription-mediated amplification and hybridization protection assay procedures to qualitatively detect Chlamydia trachomatis rRNA in urine, endocervical swab, and urethral specimens.
The performance of the AMP CT was compared to that of cell culture for endocervical swab and urine specimens from women and urethral and urine specimens from men. Analysis of specimens with discrepant results was performed by a combination of reculture, direct fluorescent-antibody (DFA) staining of specimen sediment, and amplification which targeted a different chlamydial rRNA. A total of 800 urine samples were tested by the AMP CT (607 from women and 193 from men), and 7. 1% were positive for C. trachomatis, with a sensitivity of 91.2% and a specificity of 99.6% upon discrepant analysis. A total of 926 swab specimens were tested by culture and AMP CT (717 endocervical swab specimens and 209 urethral swab specimens from men), and 7.7% were positive for C. trachomatis, with a sensitivity and specificity of 100% upon discrepant analysis.
The AMP CT is a sensitive and specific nucleic acid hybridization assay for the detection of C. trachomatis in endocervical swab specimens from women, urethral swab specimens from men, and urine specimens from men and women.
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Rosai J. Ackerman's Surgical Pathology. Eight Edition. Mosby 1996.
Sternberg S. Diagnostic Surgical Pathology. Third Edition. Lipincott Williams and Wilkins 1999.
Weedon D. Weedon's Skin Pathology. Churchill Livingstone. 1997.
Fitzpatrick's Dermatology in General Medicine. 5th Edition. McGraw-Hill. 1999.
Robbins Pathologic Basis of Disease. Sixth Edition. WB Saunders 1999.
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