PRODUCT INFORMATION

Method

Disposable saliva test that is based on biochemical functionality

Accuracy of method

The saliva’s alcohol content follows blood alcohol content very closely

Indication limit of test

The test strip’s limit is an alcohol content of 0,2 ‰ (promilles)

The values indicating reliability are based on clinical studies carried out by an independent laboratory, where genuine people consumed alcohol and used the Promilless test in actual situations. In the study, the Promilless test results were compared to blood test results carried out in the laboratory. (see below)

Result readability

The result of the test strip is clearly readable from the darkening of the green control area and the yellow test area. The result can be read as soon as the slightest colour reaction has occurred. The colour does not need to be separately compared with colour scales.

Reliability

The test strip has a self-testing feature, which indicates the functionality of the strip to the user, taking in to account any possible incorrect storage, the end of the product’s life cycle and incorrect use conditions.

Usability

Consumer product
Easy-to-use and instructions with clear images
Small cardboard packaging ( 80mm x 110mm x 4mm)
Two separate test strips packed in foil
Fits easily into a pocket or wallet
No batteries
No calibration needed

package

Result readable

The test result can be read in two minutes. An actual set time is not, however, needed.

Intended use

Product is designed to be used by consumer for checking the BAC (blood alcohol content) level, either under or above 0,2‰. Test fulfills directive 2001/95/EC for general product safety.

RESEARCH REFERENCES

Several scientific studies have shown that the alcohol content in saliva and blood go hand-in-hand (McColl, et al. 1979, Jones 1979a, Jones 1979b, Haeckel & Bucklitsch 1987, Jones 1993 and Gubala & Zuba, 2003) *.

The measurement of blood alcohol content from saliva is scientifically proven to be a reliable method.

*Source:Gubala, W. & Zuba, D. (2003) Gender differences in the pharmacokinetics of ethanol in saliva and blood after oral ingestion. Pol. J. Pharmacol. 55: 639-644.Haeckel, R. & Bucklitsch, I. (1987) The comparability of ethanol concentrations in peripheral blood and saliva. The phenomenon of variation in saliva to blood concentration ratios. J. Clin. Chem. Clin. Biochem. 25(4): 199-204.Jones, A.W. (1979a) Inter- and intra-individual variations in the saliva/blood alcohol ratio during ethanol metabolism in man. Clin. Chem. 25(8): 1394-1398.Jones, A.W. (1979b) Distribution of ethanol between saliva and blood in man. Clin. Exp. Pharmacol. Physiol. 6(1): 53-59.Jones, A.W. (1993) Pharmacokinetics of ethanol in saliva: comparison with blood and breath alcohol profiles, subjective feelings of intoxication, and diminished performance. Clin. Chem. 39(9): 1837-1844.McColl, K.E., Whiting, B., Moore, M.R. & Goldberg, A. (1979) Correlation of ethanol concentrations in blood and saliva. Clin. Sci. (Lond) 56(3): 283-286.
CONCLUSIONS FROM SCIENTIFIC STUDIES

Instant test that use saliva as an analytic are reliable indicators in determining the blood alcohol content (Jones 1995, Degutis et al. 2004)*.

The functionality of the test is based on a generally known reaction (Honchar 1978, Prencipe 1987)**.

Source:* Jones, A.W. (1995) Measuring ethanol in saliva with the QED Enzymatic test device: Comparison of results with blood- and breath-alcohol concentrations. J.Anal. Toxicol. 19: 169-174.* Degutis, L.C., Rabinovici, R., Sabbaj, A., Mascia, R. & D’Onofrio, G. (2004) The saliva test strip is an accurate method to determine blood alcohol concentration in trauma patients. Acad. Emerg. Med. 11(8): 885-887.**Honchar, M.V. (1978) A sensitive method for quantitative analysis of hydrogen peroxide and oxidase substrates in biological samples. Ukr. Biokhim. Zh. 70(5): 157-163.** Prencipe, L., Iaccheri, E. & Manzati, C. (1987) Enzymatic ethanol assay: a new colorimetric method based on measurement of hydrogen peroxide. Clin. Chem. 33(4): 486-489.
CLINICAL STUDY
“Prospective, open label, single-centre study determining the efficiency, sensitivity, specificity, positive and negative predictive value of the saliva alcohol test in healthy adults compared to conventional blood alcohol and breathalyzer measurements”

In the research programme, the functioning of the Promilless test was tested for 50 research subjects and compared to the research subjects’ blood samples as well as the results of breathalysers intended for professional and authority use. There has been a total of 300 test events.
The planning and implementation of the research protocol have been carried out by an independent party.
The research has been approved by the Ethics Committee of Pohjois-Savo Hospital District.
The research has been carried out in April-May 2016.

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