LIMITATIONS OF PROCEDURE
- Only human oral fluid should be used.
- Results on the LE5 Drug Tester are preliminary qualitative analytical test results. A positive response will require confirmation by a laboratory based reference assay.
- The presumptive presence of drugs is not a measure of intoxication.
- A negative result may not necessarily indicate a drug free sample. Drugs may be present below the stated cut off.
- Foods/medicines or preclinical errors may result in false results.
DIRECTIONS FOR USE
Prior to use, the test device and cartridge should reach room temperature (+15 to +30°C).
PERFORMANCE CHARACTERISTICS
Independent Laboratory Testing
Test strips were evaluated by two independent laboratories.
Testing used fresh saliva with no drugs provided a ‘Negative’ saliva, and with fresh saliva spiked to give drug concentrations at +50% of the cut-off, ‘Positive’ saliva. The drug concentrations were verified using LC-MSMS.
Ten independent tests were made at each drug concentration.
The drugs evaluated were Methamphetamine, Cocaine, Amphetamine, Oxycodone, ∆9-THC and Morphine*.
DRUG |
CUT-OFF ng/ml |
% ACCURACY NEG saliva (n=10) |
% ACCURACY +ive saliva (n=10) |
---|---|---|---|
Methamphetamine |
50 ng/ml |
100 |
100 |
Cocaine |
50 ng/ml |
100 |
100 |
Amphetamine |
50 ng/ml |
100 |
100 |
∆9-THC |
15 ng/ml |
100 |
100 |
Opiates |
50 ng/ml |
100 |
100 |
Oxycodone |
40 ng/ml |
100 |
100 |
SPECIFICITY
Druglizer LE5 results listed in the following table are based on our manufacturers statements provided. The specificity was evaluated by testing various drugs, their metabolites and other drugs present in oral fluid. All compounds are prepared in an artificial saliva. Positive results are obtained at concentrations greater than that listed.
DRUG TEST |
TEST COMPOUNDS |
CONCENTRATION (ng/ml) |
---|---|---|
Amphetamine (AMP50) |
D-Amphetamine |
50 |
- |
L-Amphetamine |
4,000 |
- |
β-Phenylethylamine |
25,000 |
- |
Tryptamine |
12,500 |
- |
p-Hydroxyamphetamine |
100 |
- |
(+)-3,4Methylenediozyamphetamine (MDA) |
100 |
- |
Methoxyphenamine |
12,500 |
Cocaine (COC50) |
Benzoylecgonine |
50 |
- |
Cocaine |
50 |
- |
Cocaethylene |
50 |
- |
Ecgonine |
3000 |
- |
Ecognine methyl ester |
25,000 |
Marijuana (THC25) |
∆9-Tetrahydrocannabinol |
25 |
- |
∆8-Tetrahydrocannabinol |
75 |
- |
11-nor-∆9-THC-9 COOH |
12 |
- |
11-hydroxy-∆9-THC |
300 |
Methamphetamine (MET50) |
d-Methamphetamine |
50 |
- |
Fenfluramine |
60,000 |
- |
p-Hydroxymethamphetamine |
400 |
- |
L-Phenylephrine |
6,250 |
- |
MDEA |
50 |
- |
MDMA |
50 |
- |
Procaine |
2,000 |
- |
Methoxyphenamine |
25,000 |
- |
Mephentermine |
1,500 |
- |
Ephedrine |
400 |
- |
Benzphetamine |
25,000 |
Opiates (OPI50) |
Morphine |
50 |
- |
Codeine |
30 |
- |
Diacetylmorphine (Heroin) |
75 |
- |
Ethylmorphine |
30 |
- |
Hydrocodone |
125 |
- |
Hydromorphone |
125 |
- |
6-Monoacetylmorphine (6-MAM) |
25 |
- |
Morphine-3-ß-D-Glucoronide |
75 |
- |
Narlorphine |
12,500 |
- |
Oxycodone |
31,250 |
- |
Oxymorphone |
31,250 |
- |
Thebaine |
2,500 |
- |
Levorphanol |
500 |
- |
Norcodeine |
9,000 |
- |
Normorphine |
31,250 |
- |
Pholcodine |
500 |
- |
Methadone |
1,000 |
- |
Dolantin |
1,000 |
Benzodiazepine (BZO10) |
Clobazam |
10 |
- |
Clonazepam |
25 |
- |
Delorazepam |
50 |
- |
Alprazolam |
10 |
- |
Hydroxyalprazolam |
100 |
- |
Bromazepam |
50 |
- |
Chlordiazepoxide |
50 |
- |
Clorazepate |
25 |
- |
Diazepam |
100 |
- |
Estazolam |
400 |
- |
Desalkylflurazepam |
10 |
- |
Flunitrazepam |
10 |
- |
Lorazepam |
200 |
- |
Nordiazepam |
50 |
- |
Midazolam |
400 |
- |
Norchlordiazepoxide |
10 |
- |
Oxazepam |
10 |
- |
Temazepam |
10 |
- |
Tranxene |
25 |
- |
Triazolam |
200 |
Oxycodone (OXY40) |
Oxycodone |
40 |
- |
Oxymorphone |
80 |
- |
Levorphanol |
10,000 |
- |
Hydrocodone |
1,500 |
- |
Hydromorphone |
10,000 |
- |
Naloxone |
5,000 |
- |
Naltrexone |
5,000 |
*Methamphetamine, Cocaine, Amphetamine, Opiates and Oxycodone have shown by independent laboratory to be compliant with AS/NZS 4706:2019
BIBLIOGRAPHY
- Oral Fluid Testing for Drugs of Abuse. Bosker W.M. Huestis M.A – Clin.Chem 55:11 1910-1931 2009.
- Drug Testing in oral fluid evaluation of sample collection devices.
Langel K, Engblom C, Pehrsson A, Gunner T, Ariniemi K, Lillsunde P. – j.Anal Toxicol. 2008;32: 393-401. - Current knowledge on cannabinoids in oral fluid. Lee D, Huestis M.A – Drug Test Analysis 2014, 6, 88-111.
- Methamphetamine: An update on epidemiology, pharmacology, clinical phenomenology and treatment literature. Courtney K.E Ray L.A – Drug Alcohol Depend. 2014, Oct 1; 143: 11-21.