| Sensitivity/specificity genital samples (a,b) |
Sample type |
CT % sensitivity / specificity |
NG % sensitivity / specificity |
| Male Urine |
97.5 / 99.9 |
98.0 / 99.9 |
| Female endocervical swab |
97.4 / 99.6 |
100.0 / 100 |
| Female vaginal swab |
98.7 / 99.4 |
100.0 / 99.9 |
| Female Urine |
97.6 / 99.8 |
95.6 / 99.9 |
| Pooled percent agreement extra-genital samples (a,b) |
Sample type |
CT % agreement positive / negative |
NG % agreement positive / negative |
| Rectal |
89.72% / 99.23% |
92.75% / 99.75% |
| Pharyngeal |
89.96% / 99.62% |
92.51% / 98.56% |
| Use setting (a,b) |
Table-top, not portable |
| Level 2 service (district hospital) |
| Specimen (a,b) |
Female and male urine, endocervical swab, vaginal swab, rectal swab and pharyngeal swab from asymptomatic and symptomatic patients |
| Steps; user-friendly (a,b) |
~4; sample preparation automated. Three-step process from sample provision to processing; sealed cartridge system; <1 minute hands-on time |
| Time to result (run-time) (a,b) |
~90 mins |
| Cold chain; reagent stability (a,b) |
No; to be determined |
| Power (a,b) |
Mains power or solar power |
| Training; user-friendly (a,b) |
Less than half a day |
| Connectivity for monitoring, surveillance & data export (a,b) |
Yes; computer/internet required; remote calibration; C360 platform system provides systems and epidemiology monitoring. Connectivity between GeneXpert and electronic patient records used to deliver results in published service evaluation [47]. |
| Equipment price (USD); per test price (a,b) |
~17,000 USD (with 4 modules), but could be higher; 16.20 USD (CT/NG) |
| Environmentally friendly (a,b) |
No: single use cartridge; disposal of used materials via local medical waste regulations |
| Environmental tolerance of packaged test kit and operating conditions (robust—tolerance to difficult environmental conditions) (a,b) |
Stable temperature and power required but has been used successfully in remote healthcare settings (see Table 3) |
| Internal quality control (a) |
Yes. Sample Adequacy Control on each cartridge for increased results integrity |
| Sample capacity/through-put (a) |
Various capacity readers available (single to 80 cartridge units); readers stackable for scale-up |
