Table 4.
Direct comparisons of test sensitivity and specificity compared to laboratory reference tests of THC in oral fluid at varying positivity thresholds (ng/mL THC), as reported by 4 experimental and 8 observational randomized and non-randomized comparative 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) |
|||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 0.2 |
0.5 |
1.0 |
2.0 |
5.0 |
10.0 |
27.0 |
||||||||||
| SENS | SPEC | SENS | SPEC | SENS | SPEC | SENS | SPEC | SENS | SPEC | SENS | SPEC | SENS | SPEC | |||
| Oral fluid screening tests vs. observational tests | ||||||||||||||||
| Draeger DrugTest 5000 (25) | Fierro 2014a (drivers positive for THC at a cut-off of 1 ng/mL THC in OF) | UPLC-MS/MS in OF (253; 135) | – | – | – | – | – | – | – | – | – | – | – | – | 76.3 (68.5–82.7) | 93.2 (87.2–96.5) |
| Observed signs of impairment | – | – | – | – | – | – | – | – | – | – | – | – | 19.3 (13.5–26.7) | 94.9 (89.4–97.6) | ||
| Oral fluid screening tests vs. oral fluid screening tests | ||||||||||||||||
| Draeger DrugTest 5000 (10) | Arkell 2019 (adult infrequent cannabis users) | LC-MS/MS in OF (163; 1.0: 116, 2.0: 91, 10.0: 45) | – | – | – | – | 39.7 (31.2–48.8) | 97.9 (88.9–99.6) | 44.0 (34.2–54.2) | 90.3 (81.3–95.2) | – | – | 66.7 (52.1–78.6) | 85.6 (78.1–90.8) | – | – |
| Securetec DrugWipe 5S (10) | LC-MS/MS in OF (165; 1.0: 118, 2.0: 93, 10.0: 47) | – | – | – | – | 25.4 (18.4–34.0) | 100.0 (92.4–100.0) | 28.0 (19.8–37.8) | 94.4 (86.6–97.8) | – | – | 44.7 (31.4–58.8) | 92.4 (86.1–95.9) | – | – | |
| Draeger 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) | – | – | – | – | – | – |
| Draeger DrugTest 5000 (5) | – | – | 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) | – | – | – | – | – | – | ||
| Cozart RapiScan] (50) | Drummer 2007 (drivers below alcohol limit and positive on screening for methamphetamine or THC) | GC-MS-SIM in OF (101; 73) | – | – | – | – | – | – | 18.3 (11.4–28.0) | NC | – | – | – | – | – | – |
| Securetec DrugWipe II (30) | GC-MS-SIM in OF/blood (85; 82) | – | – | – | – | – | – | 57.5 (46.1–68.2) | NC | – | – | – | – | - | – | |
| Affiniton DrugWipe 5 (20) | Logan 2014 (subjects under arrest for DUI) | GC-MS in OF (90; 23) | – | – | – | – | – | – | 43.5 (25.6–63.2) | 92.5 (83.7–96.8) | – | – | – | – | - | – |
| Draeger DrugTest 5000 (5) | GC-MS in OF (91; 24) | – | – | – | – | – | – | 58.3 (38.8–75.5) | 98.5 (92.0–99.7) | – | – | – | – | – | – | |
| Alere DDS 2 (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) | – | – | – | – |
| Draeger DrugTest 5000 (5) | 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) | – | – | – | – | |
| Concateno DDS (31) | Strano-Rossi 2012 (Group 1) (drivers stopped during roadside patrols) | UHPLC-MS/MS + GC-MSb in OF (NR) | – | – | – | – | 89 (68–109) | NR | – | – | – | – | – | – | – | – |
| Draeger DrugTest 5000 (5) | – | – | – | – | 95 (86–104) | NR | – | – | – | – | – | – | – | – | ||
| Draeger DrugTest 5000 (5) | Strano-Rossi 2012 (Group 2) (drivers stopped during roadside patrols) | UHPLC-MS/MS + GC-MSb in OF (NR) | – | – | – | – | 80 (67–92) | NR | – | – | – | – | – | – | – | – |
| Mavand RapidSTAT (15) | – | – | – | – | 69 (51–87) | NR | – | – | – | – | – | – | – | – | ||
| Mavand RapidSTAT (15) | Strano-Rossi 2012 (Group 3) (drivers stopped during roadside patrols) | UHPLC-MS/MS + GC-MSb in OF (NR) | – | – | – | – | 85 (73–97) | NR | – | – | – | – | – | – | – | – |
| Securetec DrugWipe 5+ (30) | – | – | – | – | 58 (41-75) | NR | – | – | – | – | – | – | – | – | ||
| Concateno DDS (31) | Strano-Rossi 2012 (Group 4) (drivers stopped during roadside patrols) | UHPLC-MS/MS + GC-MSb in OF (NR) | – | – | – | – | 33 (7-60) | NR | – | – | – | – | – | – | – | – |
| Securetec DrugWipe 5+ (30) | – | – | – | – | 31 (6-56) | NR | – | – | – | – | – | – | – | – | ||
| Alere DDS 2 Mobile Test System (25) | 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 5000 (5) | 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) | – | – | – | – | |
| Safecare Ora-Check (50) | Tang 2018 (adult substance abuse clinic and rehabilitation centre patients) | LC-MS in OF (285; 20) | – | – | – | – | 0.0 (0.0–16.1) | 100.0 (98.6–100.0) | – | – | – | – | – | – | – | – |
| Securetec DrugWipe 6S (20) | LC-MS in OF (429; 32) | – | – | – | – | 21.9 (11.0–38.8) | 100.0 (99.0–100.0) | – | – | – | – | – | – | – | – | |
| Ulti-Med SalivaScreen (50) | LC-MS in OF (412; 28) | – | – | – | – | 0.0 (0.0–12.1) | 100.0 (99.0–100.0) | – | – | – | – | – | – | – | – | |
2D-GC-MS = 2-dimensional gas chromatography mass spectrometry; CI = confidence interval; DDS = Drug Detection System; DUI = driving under the influence; DRE = Drug Recognition Expert; GC-MS = gas chromatography mass spectrometry; GC-MS-SIM = gas chromatography mass spectrometry with selected ion monitoring; LC-MS/MS = liquid chromatography tandem mass spectrometry; OF = oral fluid; THC = delta-9-tetrahydrocannabinol; UHPLC-MS/MS = ultra high-performance liquid chromatography mass spectrometry.
Experimental studies are demarcated in bold. Crouch 2005, Walsh 2003, and Walsh 2007 were comparative in design but did not evaluate devices against the same reference test positivity thresholds and were thus excluded from this table.
Results are for the THC alone group.
GC-MS (1 ng/mL positivity threshold) was used for THC-positive screening test results unconfirmed by UHPLC-MS/MS (2 ng/mL THC positivity threshold).