pISSN 2234-3806eISSN 2234-3814
Table. 1.
Analytical performance of LabGenius CT/NG in comparison with BD MAX CT/GC/TV
| Specimen type and target species | BD MAX CT/GC/TV Positive |
BD MAX CT/GC/TV Negative |
PPA (%) | NPA (%) | OPA (%) | Cohen’s kappa | |||
|---|---|---|---|---|---|---|---|---|---|
| LabGenius CT/NG Positive |
LabGenius CT/NG Negative |
LabGenius CT/NG Positive |
LabGenius CT/NG Negative |
||||||
| Vaginal swab (N=343) | |||||||||
| Chlamydia trachomatis | 127 | 22 | 1 | 193 | 99.2 (95.7–99.9) | 89.8 (85.0–93.1) | 93.3 (90.1–95.5) | 0.91 (0.88–0.95) | |
| Neisseria gonorrhoeae | 64 | 7 | 1 | 271 | 98.5 (91.8–99.7) | 97.5 (94.9–98.8) | 97.7 (95.5–98.8) | 0.92 (0.87–0.98) | |
| Urine (N=167) | |||||||||
| Chlamydia trachomatis | 61 | 11 | 7 | 88 | 89.7 (80.2–94.9) | 88.9 (81.2–93.7) | 89.2 (83.6–93.1) | 0.78 (0.68–0.88) | |
| Neisseria gonorrhoeae | 63 | 2 | 0 | 102 | 100 (94.3–100.0) | 98.1 (93.3–99.5) | 98.8 (95.7–99.7) | 0.93 (0.88–0.98) | |
| Total (N=510) | |||||||||
| Chlamydia trachomatis | 188 | 33 | 8 | 281 | 95.9 (92.2–97.9) | 89.5 (85.6–92.4) | 92.0 (89.3–94.0) | 0.83 (0.79–0.88) | |
| Neisseria gonorrhoeae | 127 | 9 | 1 | 373 | 99.2 (95.7–99.9) | 97.6 (95.6–98.8) | 98.0 (96.4–98.9) | 0.95 (0.92–0.98) | |
Abbreviations: CT, Chlamydia trachomatis; NG, Neisseria gonorrhoeae; TV, Trichomonas vaginalis; PPA, positive percent agreement; NPA, negative percent agreement; OPA, overall percent agreement.
Ann Lab Med 2025;45:218~222 https://doi.org/10.3343/alm.2024.0118
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