DOI: 10.1128/JCM.01766-16
Article Figures & Data
Figures
- FIG 1
Sample collection scheme and definition of patient or composite infection status. (A) Samples from women where self-obtained vaginal swab (SOV), clinician-obtained vaginal swab (COV); and endocervical swab (EC). (B) Samples from men.
Tables
- TABLE 1
Participants and prevalence by study site
Patient sex/clinic Clinic type Chlamydia (no. positive/no. enrolled [%]) Gonorrhea (no. positive/no. enrolled [%]) Trichomonas (no. positive/no. enrolled [%]) Women Eskenazi Health Services OB/GYN 12/172 (7.0) 3/172 (1.7) 12/100 (12.0) Indiana University STI 13/88 (14.8) 4/88 (4.5) 15/75 (20.0) Louisiana State University Health Sciences Center STI 15/165 (9.1) 3/165 (1.8) 22/116 (19.0) Planned Parenthood, Gulf Coast Family planning 22/415 (5.3) 4/415 (1.0) 11/74 (14.9) Planned Parenthood, Southern NE Family planning 4/160 (2.5) 2/160 (1.3) 3/68 (4.4) Planned Parenthood, Southeastern Pennsylvania Family planning 11/283 (3.9) 2/283 (0.7) 25/240 (10.4) State University of New York, Downstate Other 4/101 (4) 0/101 (0) 14/68 (20.6) University of Alabama at Birmingham STI 61/606 (10.1) 27/606 (4.5%) 52/402 (12.9%) All participants 142/1990 (7.1%) 45/1990 (2.3%) 154/1143 (13.5%) Men Indiana University STI 35/106 (33.0) 31/107 (29.0) Trichomonas testing not done using male urine Louisiana State University Health Sciences Center STI 56/278 (20.1) 35/284 (12.3) Planned Parenthood, Southern NE Family planning 7/42 (16.7) 2/42 (4.8) State University of New York, Downstate Other 13/88 (14.8) 6/90 (6.7) University of Alabama at Birmingham STI 70/316 (22.2%) 34/317 (10.7%) All participants 181/830 (21.8%) 108/840 (12.9%) - TABLE 2
BD MAX sensitivity and specificity by sample type compared to infection status for chlamydia, gonorrhea, and trichomonas
Specimen type Chlamydia Gonorrhea Trichomonas Sensitivitya Specificitya Sensitivitya Specificitya Sensitivitya Specificitya Vaginal swab Asymptomatic 100 [51/51] (93.0–100) 98.7 [734/744] (97.5–99.3) 94.1 [16/17] (73.0–99.0) 99.9 [777/778] (99.3–100) 93.1 [27/29] (78.0–98.1) 97.5 [270/277] (94.9–98.9) Symptomatic 98.9 [89/90] (94.0–99.8) 98.6 [938/951] (97.7–99.2) 96.3 [26/27] (81.7–99.3) 99.8 [1,012/1,014] (99.3–99.9) 96.7 [119/123] (91.9–98.2) 99.5 [616/619] (98.6–99.8) Total 99.3 [140/141] (96.1–99.9) 98.6 [1,672/1,695](98.0–99.1) 95.5 [42/44] (84.9–98.7) 99.8 [1,789/1,792] (99.5–99.9) 96.1 [146/152] (91.7–98.2) 98.9 [886/896] (98.0–99.4) Endocervical swab Asymptomatic 94.1 [48/51] (84.1–98.0) 99.1 [737/744] (98.1–99.5) 94.1 [16/17] (73.0–99.0) 100 [777/777] (99.5–100) 96.6 [28/29] (82.8–99.4) 98.2 [270/275] (95.8–99.2) Symptomatic 96.6 [84/87] (90.3–98.8) 99.4 [943/949] (98.6–99.7) 96.3 [26/27] (81.7–99.3) 99.9 [1,002/1,003] (99.4–100) 92.7 [114/123] (86.7–96.1) 99.8 [611/612] (99.1–100) Total 95.7 [132/138] (90.8–98.0) 99.2 [1,680/1,693] (98.7–99.6) 95.5 [42/44] (84.9–98.7) 99.9 [1,779/1,780] (99.7–100) 93.4 [142/152] (88.3–96.4) 99.3 [881/887] (98.5–99.7) Female urine Asymptomatic 92.3 [48/52] (81.8–97.0) 99.7 [747/749] (99.0–99.9) 88.9 [16/18] (67.2–96.9) 99.5 [779/783] (98.7–99.8) 93.1 [27/29] (78.0–98.1) 98.2 [272/277] (95.8–99.2) Symptomatic 91.1 [82/90] (83.4–95.4) 99.4 [952/958] (98.6–99.7) 100 [28/28] (87.9–100) 99.9 [1,019/1,020] (99.4–100) 92.8 [116/125] (86.9–96.2) 99.8 [615/616] (99.1–100) Total 91.5 [130/142] (85.8–95.1) 99.5 [1,699/1,707] (99.1–99.8) 95.7 [44/46] (85.5–98.8) 99.7 [1,798/1,803] (99.4–99.9) 92.9 [143/154] (87.7–96.0) 99.3 [887/893] (98.5–99.7) Male urine Asymptomatic 98.6 [69/70] (92.3–99.7) 99.5 [378/380] (98.1–99.9) 80.0 [4/5] (37.6–96.4) 100 [447/447] (99.1–100) No evaluation of trichomonas testing was performed in male urine No evaluation of trichomonas testing was performed in male urine Symptomatic 94.6 [105/111] (88.7–97.5) 99.3 [267/269] (97.399.8) 100 [103/103] (96.4–100) 100 [285/285] (98.7–100) Total 96.1 [174/181] (92.2–98.1) 99.4 [645/649] (98.4–99.8) 99.1 [107/108] (94.9–99.8) 100 [732/732] (99.5–100) ↵a Values shown are percentage [number of positive results/number of infections] (95% confidence interval).
- TABLE 3
Performance of female samples when comparing the BD MAX to CTQ/GCQ and Aptima assays (AC2 and ATV) using a rolling infection status calculation
Disease/sample type Sensitivity Specificity MAXa Qx assaysa Aptima assaysa P value MAXa Qx assaysa Aptima assaysa P value Chlamydia Endocervical 95.7 [132/138] (90.8–98.0) 90.3 [131/145] (84.4–94.2) 94.6 [135/145] (87.8–96.2) 0.414 99.2 [1,681/1,694] (98.7–99.6) 99.6 [1,701/1,708] (99.2–99.8) 99.4 [1,701/1,711] (98.9–99.7) 0.380 Female urine 91.5 [130/142] (85.8–95.1) 88.3 [128/145] (82.0–92.5) 87.0 [127/146] (80.6–91.5) 0.414 99.5 [1,699/1,707] (99.1–99.8) 99.8 [1,709/1,713] (99.4–99.9) 99.6 [1,701/1,708] (99.2–99.8) 0.380 Gonorrhea Endocervical 95.5 [42/44] (84.9–98.7) 97.8 [45/46] (88.7–99.6) 93.6 [44/47] (82.8–97.8) 0.760 99.9 [1,780/1,781] (99.7–100) 99.7 [1,801/1,807] (99.3–99.8) 99.9 [1,808/1,810] (99.6–100) 0.170 Female urine 95.7 [44/46] (85.5–98.8) 97.8 [45/46] (88.7–99.6) 93.6 [44/47] (82.8–97.8) 0.760 99.7 [1,798/1,803] (99.4–99.9) 99.7 [1,806/1,812] (99.3–99.8) 99.9 [1,805/1,807] (99.6–100) 0.170 Trichomonas Vaginal swabs 96.6 [143/148] (92.3–98.5) Not done 98.0 [145/148] (94.2–99.3) 1.0 98.8 [858/868] (97.9–99.4) Not done 98.2 [852/868] (97.0–98.9) 1.0 ↵a Values shown are percentage [number of positive results/number of infections] (95% confidence interval).
- TABLE 4
Head-to-head comparison of MAX TV and other assays for detection of trichomonas
Test type MAX TV (−) MAX TV (+) Percent agreementa (95% CI) Overall agreement (95% CI) Wet prep (−) 889 68 NPA = 92.9 (91.9–94.6) 93.2 (91.5–94.6) Wet prep (+) 3 88 PPA = 96.7 (90.8–98.9) Culture (−) 886 11 NPA = 98.8 (97.8–99.3) 98.4 (97.4–99.0) Culture (+) 6 145 PPA = 96.0 (91.6–98.2) ATV (−) 852 3 NPA = 99.6 (99.0–99.9) 98.6 (97.7–99.2) ATV (+) 11 150 PPA = 93.2 (88.2–96.1) ↵a Positive (PPA) and negative (NPA) percent agreement calculated on the presumption that the reference method is 100% accurate.
