Table 3.
Sensitivity and specificity of investigated oral fluid screening tests compared to laboratory reference tests of THC in oral fluid at positivity thresholds ranging from 0 to 5 ng/mL THC, as reported by 9 experimental studies of roadside tests for cannabis use.
| Screening Test (positivity threshold, ng/mL THC) | Study (sample) | Laboratory Reference Test (n tests; n reference test positives) | Sensitivity and specificity (% [95% CI]) at varying positivity thresholds (ng/mL THC) |
|||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 0–0.5 |
1.0 |
2.0 |
5.0 |
|||||||
| SENS | SPEC | SENS | SPEC | SENS | SPEC | SENS | SPEC | |||
| Alere DDS | ||||||||||
| Alere DDS 2 Mobile Test System (25) | Newmeyer 2017 (adult occasional and frequent cannabis users) | LC-MS/MS in OF (134; 0.2: 93, 1.0: 60, 2.0: 60, 5.0: 31) | 44.1 (34.4–54.2) | 92.7 (80.6–97.5) | 61.7 (49.0–72.9) | 90.5 (81.7–95.3) | 61.7 (49.0–72.9) | 90.5 (81.7–95.3) | 96.8 (83.8–99.4) | 86.4 (78.5–91.7) |
| Swortwood 2017 (adult occasional and frequent cannabis users) | LC-MS/MS in OF (545; 0.2: 397, 1.0: 265, 2.0: 212, 5.0: 147) | 36.5 (31.9–41.4) | 99.3 (96.3–99.9) | 53.2 (47.2–59.1) | 98.2 (95.9–99.2) | 65.1 (58.5–71.2) | 97.6 (95.3–98.8) | 84.4 (77.6–89.3) | 94.5 (91.8–96.3) | |
| Draeger DrugTest | ||||||||||
| DrugTest 5000 (10) | Desrosiers 2012 (adult current cannabis smokers) | 2D-GC-MS in OF (66; 0.5: 58, 1.0: 57, 2.0: 54) | 75.9 (63.5–85.0) | 100.0 (67.6–100.0) | 77.2 (64.8–86.2) | 100.0 (70.1–100.0) | 81.5 (69.2–89.6) | 100.0 (75.8–100.0) | – | – |
| Arkell 2019 (adult infrequent cannabis users) | LC-MS/MS in OF (163; 1.0: 116, 2.0: 91) | – | – | 39.7 (31.2–48.8) | 97.9 (88.9–99.6) | 44.0 (34.2–54.2) | 90.3 (81.3–95.2) | – | – | |
| DrugTest 5000 (5) | Toennes 2013 (heavy cannabis users) | GC-MS in OF (282; 269) | – | – | – | – | – | – | 94.4 (91.0–96.6) | 15.4 (4.3–42.2) |
| Newmeyer 2017 (adult occasional and frequent cannabis users) | LC-MS/MS in OF (103; 0.2: 83, 1.0: 56, 2.0: 56, 5.0: 28) | 34.9 (25.6–45.7) | 100.0 (83.9–100.0) | 50.0 (37.3–62.7) | 97.9 (88.9–99.6) | 50.0 (37.3–62.7) | 97.9 (88.9–99.6) | 89.3 (72.8–96.3) | 94.7 (87.1–97.9) | |
| Swortwood 2017 (adult occasional and frequent cannabis users) | LC-MS/MS in OF (551; 0.2: 401, 1.0: 252, 2.0: 208, 5.0: 145) | 36.9 (32.3–41.7) | 99.3 (96.3–99.9) | 57.5 (51.4–63.5) | 98.7 (96.6–99.5) | 66.3 (59.7–72.4) | 96.8 (94.4–98.2) | 80.0 (72.8–85.7) | 91.9 (88.8–94.2) | |
| Desrosiers 2012 (adult current cannabis smokers) | 2D-GC-MS in OF (66; 0.5: 58, 1.0: 57, 2.0: 54) | 86.2 (75.1–92.8) | 75.0 (40.9–92.8) | 87.7 (76.8–93.9) | 77.8 (45.3–93.7) | 90.7 (80.1–95.6) | 75.0 (46.8–91.1) | – | - | |
| Desrosiers 2014 (adult occasional and frequent cannabis users) (Oral-Eze/StatSure)a | 2D-GC-MS in OF (394; 1.0: 303, 2.0: 258/395; 1.0: 294, 2.0: 258) | – | – | 66.7 (61.2–71.7)/66.7 (61.1–71.8) | 98.9 (94.0–99.8)/93.1 (86.4–96.6) | 75.6 70.0–80.4)/74.0 (68.4–79.0) | 94.1 (88.8–97.0)/91.2 (85.3–94.9) | – | - | |
| Hartman 2015 (adult occasional cannabis users) (all sessions/high-dose THC sessions) | 2D-GC-MS in OF (1710; 1.0: 1125, 2.0: 961, 5.0: 719/546; 1.0: 456, 2.0: 411, 5.0: 333) | – | – | 40.4 (37.5–43.2)/48.7 (44.1–53.3) | 99.8 (99.0–100.0)/100.0 (95.9–100.0) | 47.0 (43.9–50.2)/53.8 (48.9–58.5) | 99.6 (98.8–100.0)/99.3 (95.9–99.9) | 60.8 (57.2–64.3)/64.9 (59.6–69.8) | 98.2 (97.2–98.8)/97.2 (94.0–98.7) | |
| Securetec DrugWipe | ||||||||||
| DrugWipe 5S (15) | Wille 2015 (adult regular cannabis users) | UPLC-MS/MS in OF (79; 60) | – | – | 43.3 (31.6–55.9) | 100.0 (83.2–100.0) | – | – | – | – |
| DrugWipe 5S (10) | Arkell 2019 (adult infrequent cannabis users) | LC-MS/MS in OF (165; 1.0: 118, 2.0: 93) | – | – | 25.4 (18.4–34.0) | 100.0 (92.4–100.0) | 28.0 (19.8–37.8) | 94.4 (86.6–97.8) | – | – |
| Tests in Development | ||||||||||
| Disposable screen-printed carbon electrode (0)b | Wanklyn 2016 (cannabis smokers and non-cannabis smokers) | LC-MS/MS in OF (508; 337) | 28.2 (23.6–33.2) | 98.8 (95.8–99.7) | – | – | – | – | – | – |
2D-GC-MS = 2-dimensional gas chromatography mass spectrometry; CI = confidence interval; DDS = Drug Detection System; GC-MS = gas chromatography mass spectrometry; LC-MS/MS = liquid chromatography tandem mass spectrometry; OF = oral fluid; THC = delta-9-tetrahydrocannabinol; UPLC-MS/MS = ultra-performance liquid chromatography tandem mass spectrometry.
Comparative studies are demarcated in bold.
2 OF samples for confirmatory analysis were collected per participant per test using two different collection devices (Oral-Eze and StatSure). OF samples collected with each device were analyzed separately and resulting sensitivity and specificity results were reported separately.
A cut-off value for the current was calculated using the CA3-CA1 current responses for samples containing 0 ng/mL Δ9-THC. The cut-off was defined as the average CA3-CA1 current plus 2 standard deviations. Results show sensor performance at different time points (s) in the CA3-CA1 response (method involves 3 CA steps, CA3-CA1). Results are reported for optimal performance (0.050–0.075).