| Study, year | Screening test(s) | Definition of a positive screening exam | Reference standard(s) | Country Setting Prevalence |
|---|---|---|---|---|
| NAATs vs. NAATs | ||||
| Chernesky et al, 200531 | ACT Site: urethral swab, FCU | Positive result from at least 1 NAAT in both urethral swab and FCU; or one specimen positive on both NAATs | AC2 PTGC | Canada, U.S. STI clinics |
| Gaydos et al, 201336 | Xpert Site: self-collected vaginal, cervix, female FCU, male FCU | Positive result from at least 1 of the reference NAATs | AC2 PTGC | U.S. STI clinics |
| Schachter et al, 200337 | ACT, Amplicor Site: FCU, cervix, clinician-collected vaginal, self-collected vaginal | Agreement between positive results with vaginal swab and cervical swab or FCU | Culture | U.S., Canada Family planning, obstetrics/gynecology, and STI clinics CT prevalence across sites: 5.4% to 10.2% by culture |
| Schoeman et al, 201240 | AC2 Site: endocervix, self-collected vaginal | Positive result from 1 NAAT confirmed by second NAAT | Aptima CT | United Kingdom Sexual health clinic Prevalence: NR |
| Shrier et al, 200438 | Amplicor Site: endocervix, FCU, clinician-collected vaginal, self-collected vaginal | 1 positive culture or 2 positive nonculture tests or 1 positive nonculture test confirmed by nested PCR | Culture Amplicor Abbot LCx assay | U.S. University medical center and children's hospital 21.6% positive for CT at any site |
| Taylor et al, 201232 | c4800 Site: FCU AC2, CT/GC Qx Site: FCU, urethral swab | Positive result from ≥2 NAATs with different target regions in urethral swab and/or FCU | AC2 CT/GC Qx | U.S. Obstetrics/gynecology, family planning, and STI clinics Prevalence ≥1% |
| Taylor et al, 201139 | CTQ, PTCT, AC2 Site: endocervical, female FCU, urethral swab, male FCU, all female sites, all male sites | ≥1 positive result from each reference NAAT; for assay comparison, positive result required from each of other 2 assays | AC2 PTCT | U.S. Family planning, obstetrics/gynecology, and STI clinics CT prevalence across sites: 11.6% in females, 21.4% in males |
| Van Der Pol et al, 201233 | c4800, AC2, CT/GC Qx Site: endocervical, FCU | Positive result from ≥2 NAATs with different target regions in endocervical swab and/or FCU; each NAAT was evaluated based on results of other 2 NAATs | AC2 CT/GC Qx | U.S. Family planning, obstetrics/gynecology, and STI clinics Prevalence NR |
| Study, year | Population Characteristics | Eligibility Criteria | Sample size Proportion with condition |
|---|---|---|---|
| NAATs vs. NAATs | |||
| Chernesky et al, 200531 | Age (mean): 28.5 y 100% male 62.2% non-Hispanic black, 24.6% white | Men ages 15 to 77 y. Excluded if they could not concurrently provide all samples, had urinated within 1 hour, had taken antibiotics in the last 21 days, or if they could not provide informed consent. | 1322 enrolled 17.9% CT 13.8% NG |
| Gaydos et al, 201336 | Age: ≥14 y (range or mean NR) 45% male (full sample, asymptomatic information NR separately) Race: NR | Age ≥14 y, sexually active in the last 6 months, and attending a participating clinic. Excluded if enrolled in previous trial, received antimicrobial therapy within 21 days of study, or history of hysterectomy. | 2,270 asymptomatic 3.5% CT 0.7% NG |
| Schachter et al, 200337 | Age (range): 16 to 25 y 100% female Race: NR | Females ages 16 to 25 y who were not pregnant and attending a study clinic for routine exam or birth control advice. Excluded if they had been treated with antibiotics within the last 30 days, were attending the clinic because of symptoms, or had a male partner treated for genital symptoms. | 2517 tested 9.6% of women with CT by culture of 1 specimen |
| Schoeman et al, 201240 | Age (mean): 25 y 100% female Ethnicity: 80% white, 9% black, 7% mixed, 4% other | Women age ≥16 y presenting to study clinic for a new visit. Excluded if used antibiotics in the preceding 28 days, were unable or unwilling to perform self-taken swab, or have the standard exam and swabs performed by clinicians. | 3973 enrolled 10.3% with CT |
| Shrier et al, 200438 | Age (mean): 19 y 100% female 22% history of CT Median time since previous CT infection: 539 days (range, 43 to 2738) 8% with history of other STI | Females ages 16 to 25 y who had ever had sexual intercourse, did not report symptoms of an STI, and were being seen at clinic for routine gynecologic care. Excluded if they were pregnant, had taken antibiotics in the previous 21 days, were diagnosed with CT in the previous 6 weeks, or had sexual contact with a partner diagnosed with an STI. | 139 eligible 126 analyzed 21.6% CT 2% NG or trichomoniasis (1 participant had CT and NG) |
| Taylor et al, 201232 | Age: 55% ≤30 y 100% male Race: 64.7% black, 32.9% white, 0.4% Asian, 0.4% American Indian/Alaskan Native, 0.1% Hawaiian/Pacific Islander, 1.3% other, 0.1% unknown Ethnicity: 82.7% non-Hispanic, 15.1% Hispanic, 2.2% unknown ethnicity | Men age ≥14 y. Excluded if they had been previously enrolled in the study or used antimicrobials effective against CT or NG in the preceding 21 days. | 768 enrolled 16.4% CT 9.2% NG |
| Taylor et al, 201139 | Age (range): 17 to 64 y 32% male Race: NR Note: 2.7% of females were pregnant | Men and women ages 17 to 64 y who presented with urogenital symptoms or were being screened for CT and NG. Excluded if they had taken antibiotics in the previous 21 days, urinated in the previous hour, had sample collection issues, did not provide informed consent, or were younger than the age required by the site's IRB. | 1538 enrolled 11.6% of females with CT 21.4% of males with CT |
| Van Der Pol et al, 201233 | Age: ≥14 y 100% female 43.1% black, 48.4% white, 22.1% Hispanic, 2.8% Asian/Pacific Islander, 5.7% other | Women age ≥14 y who were eligible for routine CT/NG screening as per standard practice at each enrollment site. Excluded if they had been previously enrolled, used antimicrobial agents active against CT or NG in preceding 21 days, used Raplense, a vaginal lubricant, within the past 3 days, or had a history of hysterectomy or contraindication to Pap test/cervical sampling. | 4479 enrolled 6.3% CT 1.5% NG |
| Study, year | Screening test(s) | Proportion unexaminable by screening test | Number of indeterminate results | Proportion who underwent reference standard and included in analysis | True positives | False positives | False negatives | True negatives | Sensitivity (95% CI) |
|---|---|---|---|---|---|---|---|---|---|
| NAATs vs. NAATs | |||||||||
| Chernesky et al, 200531 | ACT Site: urethral swab | NR | NR | 100% | 94 | 16 | 1 | 634 | 98.9% (94.3 to 100) |
| Site: FCU | 94 | 19 | 1 | 638 | 98.9% (94.3 to 100) | ||||
| Gaydos et al, 201336 | Xpert Site: self-collected vaginal | NR | 0.25% (total sample) were invalid and unreadable | 99.6% | 48 | 7 | 1 | 1076 | 98.0% (89.1 to 99.9) |
| Site: cervix | 46 | 6 | 2 | 1074 | 95.8% (85.7 to 99.5) | ||||
| Site: female FCU | 49 | 2 | 2 | 1083 | 96.1% (86.5 to 99.5) | ||||
| Site: male FCU | 29 | 1 | 0 | 1102 | 100% (90.2 to 100) | ||||
| Schachter et al, 200337 | ACT Site: FCU | Not reported | Not reported | Unclear | 86* | 7 | 33* | 1265* | 72.0% |
| Site: cervix | 106* | 10 | 13* | 1262* | 89.1% | ||||
| Site: clinician-collected vaginal | 107* | 9 | 12* | 1263* | 89.9% | ||||
| Site: self-collected vaginal | 111* | 6 | 8* | 1266* | 93.3% | ||||
| Amplicor Site: FCU | 63* | 5 | 12* | 501* | 84.0% | ||||
| Site: cervix | 68* | 3 | 7* | 503* | 90.7% | ||||
| Site: clinician-collected vaginal | 70* | 6 | 5* | 500* | 93.3% | ||||
| Site: self-collected vaginal | 68* | 5 | 7* | 501* | 90.7% | ||||
| Schoeman et al, 201240 | AC2 Site: endocervix | 0.7% | 4 | 97.3% | 163 | 0 | 20 | 2050 | 89.0% (84.0 to 93.0) |
| Site: self-collected vaginal | 178 | 1 | 5 | 2049 | 97.0% (94.0 to 99.0) | ||||
| Shrier et al, 200438 | Amplicor Site: endocervix | 1 participant excluded because no samples were collected by physician | None reported; 8 participants had a single positive result that needed confirmation by nested PCR | 90.6% (analysis only included eligible participants with results on all tests) | 14 | 0 | 13 | 99 | 51.9% (32.0 to 71.3) |
| Site: FCU | 12 | 0 | 15 | 99 | 44.4% (26.9 to 63.6) | ||||
| clinician-collected vaginal | 15 | 0 | 12 | 99 | 55.6% (36.4 to 73.1) | ||||
| self-collected vaginal | 14 | 1 | 13 | 98 | 51.9% (32.0 to 71.3) | ||||
| Taylor et al, 201232 | c4800 Site: FCU | 2.9% | NR | 97.1% | 51 | 2 | 1 | 418 | 98.1% (89.9 to 99.7) |
| AC2 Site: FCU | 50 | 4 | 1 | 417 | 98.0% (89.7 to 99.7) | ||||
| Site: urethral swab | 48 | 5 | 3 | 416 | 94.1% (84.1 to 98.0) | ||||
| CT/GC Qx Site: FCU | 50 | 2 | 2 | 418 | 96.2% (87.0 to 98.9) | ||||
| Site: urethral swab | 45 | 1 | 7 | 419 | 86.5% (74.7 to 93.3) | ||||
| Taylor et al, 201139 | CTQ Site: endocervical | 4.7%; 13% of men had only 2 urethral swabs collected rather than 3 | 19 unable to calculate from PTCT; 7/19 resolved negative All 19 were negative by CTQ and AC2 | 95.3% | 53 | 8 | 4 | 385 | 93.0% (83.0 to 98.1) |
| Site: female FCU | 54 | 2 | 3 | 391 | 94.7% (85.4 to 98.9) | ||||
| Site: urethral swab | 31 | 2 | 4 | 178 | 88.6% (73.3 to 96.8) | ||||
| Site: Male FCU | 35 | 2 | 0 | 178 | 100.0% (90.0 to 100.0) | ||||
| All female sites | 216 | 12 | 12 | 1559 | 94.7% (91.0 to 97.3) | ||||
| All male sites | 101 | 6 | 4 | 534 | 96.2% (90.5 to 99.0) | ||||
| PTCT Site: endocervical | 51 | 0 | 8 | 379 | 86.4% (75.0 to 94.0) | ||||
| Site: female FCU | 53 | 1 | 6 | 384 | 89.8% (79.2 to 96.2) | ||||
| Site: urethral swab | 31 | 2 | 5 | 173 | 86.1% (70.5 to 95.3) | ||||
| Site: male FCU | 35 | 1 | 1 | 173 | 97.2% (85.5 to 99.9) | ||||
| All female sites | 104 | 1 | 14 | 763 | 88.1% (80.9 to 93.4) | ||||
| All male sites | 66 | 3 | 6 | 346 | 91.7% (82.7 to 96.9%) | ||||
| AC2 Site: endocervical | 52 | 4 | 4 | 389 | 92.9% (82.7 to 98.0) | ||||
| Site: female FCU | 55 | 2 | 1 | 392 | 98.2% (90.4 to 100.0) | ||||
| Site: urethral swab | 30 | 2 | 3 | 166 | 90.9% (75.7 to 98.1) | ||||
| Site: male FCU | 35 | 0 | 1 | 179 | 97.2% (85.5 to 99.9) | ||||
| All female sites | 107 | 6 | 5 | 781 | 95.5% (89.9 to 98.5) | ||||
| All male sites | 65 | 2 | 4 | 345 | 94.2% (85.8 to 98.4) | ||||
| Van Der Pol et al, 201233 | c4800 Site: endocervical | 3.6% of enrolled; 16.4% for primary analysis of particular specimen type | NR | 96.4% | 94 | 1 | 11 | 2163 | 89.5% (82.2 to 94.0) |
| Site: FCU | 98 | 4 | 12 | 2165 | 89.1% (81.9 to 93.6) | ||||
| AC2 Site: endocervical | 101 | 12 | 3 | 2173 | 97.1% (91.9 to 99.0) | ||||
| Site: FCU | 98 | 5 | 8 | 2181 | 92.5% (85.8 to 96.1) | ||||
| CT/GC Qx Site: endocervical | 102 | 7 | 4 | 2155 | 96.2% (90.7 to 98.5) | ||||
| Site: FCU | 101 | 6 | 4 | 2161 | 96.2% (90.6 to 98.5) | ||||
| Study, year | Screening test(s) | Specificity (95% CI) | Positive likelihood ratio (95% CI) | Negative likelihood ratio (95% CI) | Positive predictive value (95% CI) | Negative predictive value (95% CI) | Sponsor | Quality rating |
|---|---|---|---|---|---|---|---|---|
| NAATs vs. NAATs | ||||||||
| Chernesky et al, 200531 | ACT Site: urethral swab | 97.5% (96.0 to 98.6) | 40.2 (24.8 to 65.3)* | 0.01 (0.00 to 0.08)* | 85.5% (77.5 to 91.5)* | 99.8% (99.1 to 100)* | NR | Fair |
| ACT Site: FCU | 98.0% (96.6 to 98.9) 97.1% (95.5 to 98.3)* | 34.2 (22.0 to 53.3)* | 0.01 (0 to 0.08)* | 83.2% (75 to 89.6)* | 99.8% (99.1 to 100)* | |||
| Gaydos et al, 201336 | Xpert Site: self-collected vaginal | 99.4% (98.7 to 99.7) | 151.6 (72.3 to 317.5)* | 0.02 (0.00 to 0.14)* | 87.3% (75.5 to 94.7) | 99.9% (99.5 to 99.9) | Cepheid, grant from National Insitute of Biomedical Imaging and Bioengineering | Fair |
| Site: cervix | 99.4% (98.8 to 99.8) | 172.5 (77.5 to 383.9)* | 0.04 (0.01 to 0.16)* | 88.5% (76.5 to 95.6) | 99.8% (99.3 to 99.7) | |||
| Site: female FCU | 99.8% (99.3 to 100) | 521.2 (130.4 to 2083.8)* | 0.04 (0.01 to 0.15)* | 96.1% (86.5 to 99.4) | 99.8% (99.3 to 99.9) | |||
| Site: male FCU | 99.9% (99.5 to 100) | 1103.0 (155.5 to 7823.6)* | 0.00* | 96.7% (82.7 to 99.4) | 100% (99.6 to 100) | |||
| Schachter et al, 200337 | ACT Site: FCU | 99.5% | 131.3 (62.2 to 277.2)* | 0.28 (0.21 to 0.37)* | 92.5% (85.1 to 96.9)* | 97.5% (96.5 to 98.2)* | Roche Molecular Systems; Abbott Laboratories; GenProbe, Inc; CDC | Fair |
| Site: cervix | 99.3% | 113.3 (60.9 to 210.7)* | 0.11 (0.07 to 0.18)* | 91.4% (84.7 to 95.8)* | 99.0% (98.3 to 99.5)* | |||
| Site: clinician-collected vaginal | 99.4% | 127.1 (66.1 to 244.4)* | 0.10 (0.06 to 0.17)* | 92.2% (85.8 to 96.4)* | 99.1% (98.4 to 99.5)* | |||
| Site: self-collected vaginal | 99.6% | 197.8 (88.9 to 440.0)* | 0.07 (0.03 to 0.13)* | 94.9% (89.2 to 98.1) | 99.4% (98.8 to 99.7) | |||
| Amplicor Site: FCU | 99.0% | 85.0 (35.3 to 204.5) | 0.16 (0.10 to 0.27)* | 92.7% (83.7 to 97.5)* | 97.7% (96.0 to 98.8)* | |||
| Site: cervix | 99.4% | 152.9 (49.4 to 473.7)* | 0.09 (0.05 to 0.19)* | 95.8% (88.1 to 99.1)* | 98.6% (97.2 to 99.4)* | |||
| Site: clinician-collected vaginal | 98.8% | 78.7 (35.5 to 174.7)* | 0.07 (0.03 to 0.16)* | 92.1% (83.6 to 97.0)* | 99.0% (97.7 to 99.7)* | |||
| Site: self-collected vaginal | 99.0% | 91.8 (38.2 to 220.2)* | 0.09 (0.05 to 0.19)* | 93.2% (84.7 to 97.7)* | 98.6% (97.2 to 99.4)* | |||
| Schoeman et al, 201240 | AC2 Site: endocervix | 100% (99.8 to 100.0) | Unable to calculate | 0.11 (0.07 to 0.17)* | 100.0% (97.7 to 100.0)* | 99.0% (98.5 to 99.4)* | None reported (GenProbe provided supplies) | Good |
| Site: self-collected vaginal | 99.9% (99.7 to 100.0) | 1994.0 (281.0 to 14151.3)* | 0.03 (0.01 to 0.06)* | 99.4% (96.9 to 99.9)* | 99.8% (99.4 to 99.9)* | |||
| Shrier et al, 200438 | Amplicor Site: endocervix | 100% (96.5 to 100) | Unable to calculate | 0.48 (0.33 to 0.71)* | 100% (77.0 to 100) | 88.4% (81.1 to 93.6) | Roche Molecular Systems, Inc; CDC; NIMH, NIH | Good |
| Site: FCU | 100% (96.5 to 100) | 0.56 (0.40 to 0.78) | Unable to calculate | 100% (76.4 to 100) | 86.8% (79.6 to 92.3) | |||
| Site: clinician-collected vaginal | 100% (96.5 to 100) | Unable to calculate | 0.44 (0.29 to 0.68)* | 100% (78.7 to 100) | 89.2% (82.4 to 94.0) | |||
| Site: self-collected vaginal | 99.0% (95.0 to 100) | 51.3 (7.1 to 373.2)* | 0.49 (0.33 to 0.72)* | 93.3% (69.8 to 99.7) | 88.3% (81.0 to 93.5) | |||
| Taylor et al, 201232 | c4800 Site: FCU | 99.5% (98.3 to 99.9) | 206.0 (51.7 to 821.3)* | 0.02 (0.00 to 0.13)* | 96.2% (87.0 to 99.4)* | 99.8% (98.7 to 100.0)* | Roche Molecular Systems | Fair |
| AC2 Site: FCU | 99.0% (97.6 to 99.6) | 103.2 (38.9 to 273.9)* | 0.02 (0.00 to 0.14)* | 92.6% (82.1 to 97.9)* | 99.8% (98.7 to 100.0)* | |||
| Site: urethral swab | 98.9% (97.3 to 99.5) | 79.3 (33.1 to 189.9)* | 0.06 (0.02 to 0.18)* | 90.6% (79.3 to 96.8)* | 99.3% (97.9 to 99.8)* | |||
| CT/GC Qx Site: FCU | 99.5% (98.3 to 99.9) | 201.9 (50.6 to 805.6)* | 0.04 (0.01 to 0.15)* | 96.2% (86.8 to 99.4)* | 99.5% (98.3 to 99.9)* | |||
| Site: urethral swab | 99.8% (98.7 to 100.0) | 363.5 (51.2 to 2581.9)* | 0.13 (0.07 to 0.27)* | 97.8% (88.4 to 99.6)* | 98.4% (96.6 to 99.3)* | |||
| CTQ Site: endocervical | 98.0% (96.0 to 99.1) | 45.7 (22.3 to 91.0)* | 0.07 (0.03 to 0.18)* | 86.9% (75.8 to 94.2)* | 99.0% (97.4 to 99.7)* | BD Diagnostics | Fair | |
| Site: female FCU | 99.5% (98.2 to 99.9) | 186.2 (46.7 to 742.7)* | 0.05 (0.02 to 0.16)* | 96.4% (87.7 to 99.5)* | 99.2% (97.8 to 99.8)* | |||
| Site: urethral swab | 98.9% (96.0 to 99.9) | 79.7 (20.0 to 317.9)* | 0.12 (0.05 to 0.29)* | 93.9% (79.7 to 99.1)* | 97.8% (94.5% to 99.4)* | |||
| Site: Male FCU | 98.9% (96.0 to 99.9) | 90.0 (22.7 to 357.1)* | 0.00* | 94.6% (81.8 to 99.2)* | 100.0% (97.9 to 100.0)* | |||
| All female sites | 99.2% (98.7 to 99.6) | 124.0 (70.5 to 218.1)* | 0.05 (0.03 to 0.09)* | 94.7% (91.0 to 97.3)* | 99.2% (98.7 to 99.6)* | |||
| All male sites | 98.9% (97.6 to 99.6%) | 86.6 (39.0 to 192.0)* | 0.04 (0.01 to 0.10)* | 94.4% (88.2 to 97.9)* | 99.3% (98.1 to 99.8)* | |||
| PTCT Site: endocervical | 100.0% (99.0 to 100.0) | Unable to calculate | 0.14 (0.07 to 0.26)* | 100.0% (93.0 to 100.0)* | 97.9% (96.0 to 99.1)* | |||
| Site: female FCU | 99.7% (98.6 to 100.0) | 345.9 (48.8 to 2453.7)* | 0.10 (0.05 to 0.22)* | 98.2% (90.1 to 99.7)* | 98.5% (96.7 to 99.4)* | |||
| Site: urethral swab | 98.9% (95.9 to 99.9) | 75.4 (18.9 to 300.8)* | 0.14 (0.06 to 0.32)* | 93.9% (79.7 to 99.1)* | 97.2% (93.6 to 99.1)* | |||
| Site: male FCU | 99.4% (96.8 to 100.0) | 169.2 (23.9 to 1195.2)* | 0.03 (0.00 to 0.19)* | 97.2% (85.4 to 99.5)* | 99.4% (96.8 to 99.9)* | |||
| All female sites | 99.9% (99.3 to 100.0) | 673.4 (94.9 to 4779.6)* | 0.12 (0.07 to 0.19)* | 99.1% (94.8 to 99.8)* | 98.2% (97.0 to 99.0)* | |||
| All male sites | 99.1% (97.5 to 99.8) | 106.6 (34.5 to 329.8)* | 0.08 (0.04 to 0.18)* | 95.6% (87.8 to 99.0)* | 98.3% (96.3 to 99.4)* | |||
| AC2 Site: endocervical | 99.0% (97.4 to 99.7) | 91.2 (34.3 to 242.5)* | 0.07 (0.03 to 0.19)* | 92.9% (82.7 to 98.0)* | 99.0% (97.4 to 99.7)* | |||
| Site: female FCU | 99.5% (98.2 to 99.9) | 193.5 (48.5 to 771.3)* | 0.02 (0.00 to 0.13)* | 96.5% (87.9 to 99.5)* | 99.8% (98.6 to 100.0)* | |||
| Taylor et al, 201139 | AC2 Site: urethral swab | 98.8% (95.8 to 99.9) | 76.4 (19.2 to 304.1)* | 0.09 (0.03 to 0.27)* | 93.8% (79.2 to 99.1)* | 98.2% (94.9 to 99.6)* | BD Diagnostics | Fair |
| Site: male FCU | 100.0% (98.0 to 100.0) | Unable to calculate | 0.03 (0.00 to 0.19)* | 100.0% (89.9 to 100.0)* | 99.4% (96.9 to 99.9)* | |||
| All female sites | 99.2% (98.3 to 99.7) | 125.3 (56.4 to 278.4)* | 0.04 (0.02 to 0.11)* | 94.7% (88.8 to 98.0)* | 99.4% (98.5 to 99.8)* | |||
| All male sites | 99.4% (97.9 to 99.9) | 163.4 (41.0 to 651.7)* | 0.06 (0.02 to 0.15)* | 97.0% (89.6 to 99.6)* | 98.9% (97.1 to 99.7)* | |||
| Van Der Pol et al, 201233 | c4800 Site: endocervical | 100.0% (99.7 to 100.0) | 1937.3 (272.7 to 13762.3)* | 0.10 (0.06 to 0.18)* | 99.0% (94.3 to 99.8)* Note: authors estimate PPV of 77.3% to 99.7% (based on hypothetical prevalence range of 1% to 50%) | 99.5% (99.1 to 99.8)* | Roche Molecular Systems | Fair |
| Site: FCU | 99.8% (99.5 to 99.9) | 483.1 (181.1 to 1288.8)* | 0.11 (0.06 to 0.19)* | 96.1% (90.3 to 98.9)* | 99.5% (99.0 to 99.7)* | |||
| AC2 Site: endocervical | 99.5% (99.0 to 99.7) | 176.8 (100.5 to 311.2)* | 0.03 (0.01 to 0.09)* | 89.4% (82.2 to 94.4)* | 99.9% (99.6 to 100.0)* | |||
| Site: FCU | 99.8% (99.5 to 99.9) | 404.2 (168.1 to 971.8)* | 0.08 (0.04 to 0.15)* | 95.2% (89.0 to 98.4)* | 99.6% (99.3 to 99.8)* | |||
| CT/GC Qx Site: endocervical | 99.7% (99.3 to 99.8) | 297.2 (141.7 to 623.3)* | 0.04 (0.01 to 0.10)* | 93.6% (87.2 to 97.3)* | 99.8% (99.5 to 100.0)* | |||
| Site: FCU | 99.7% (99.4 to 99.9) | 347.4 (156.1 to 773.1)* | 0.04 (0.01 to 0.10)* | 94.4% (88.2 to 97.9)* | 99.8% (99.5 to 100.0)* | |||
Calculated.
Abbreviations: AC2 = Aptima Combo 2; ACT = Aptima Chlamydia trachomatis test; Amplicor = Roche cobas Amplicor test; BD = Becton Dickinson; c4800= Roche cobas 4800 CT and NG test; CDC = Centers for Disease Control and Prevention; CI = confidence interval; CT = Chlamydia trachomatis; CTQ = BD ProbeTec CT Qx amplified DNA assay on the Viper system; CT/GC Qx = BD ProbeTec CT and NG Qx amplified DNA assay; EIA = enzyme immunoassay; FCU = first-catch urine; IRB = institutional review board; NAAT = nucleic acid amplification test; NG = Neisseria gonorrhea; NIH = National Institutes of Health; NIMH = National Institute for Mental Health; NR = not reported; PCR = polymerase chain reaction; PT = ProbeTech; PTCT = BD ProbeTech ET CT amplified DNA assay; PTGC = BD ProbeTech ET amplified DNA assay for CT and NG; STI = sexually transmitted infection.
From: Appendix C, Evidence and Quality Tables
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