ALFA Scientific Designs's drugs of abuse saliva test

Dr. Wang recognized the need for high quality rapid diagnostic screening tests that would be reliable and readily available to the medical professionals. This method of medical in-vitro rapid diagnostic devices is a relatively new technology. It provides test results in just a few minutes and no equipment is required. These advantages make these tests very popular with the point of care market.

Alfa is a privately held corporation whose principals are highly educated and experienced scientists with diverse backgrounds. Since its inception, Alfa Scientific Designs has developed an extensive line of rapid testing products. We now manufacture and supply over 40 products in the rapid test industry. Alfa is dedicated to consistently provide high quality products. In this pursuit, Alfa is FDA regulated and has attained ISO 13485 certificate.

Alfa Scientific Designs’ objective has always been “to develop high quality, novel and advanced in-vitro diagnostic devices for the drug of abuse, infectious disease, pregnancy, fertility, cardiac and cancer markets”. To support this objective Alfa Scientific has formed strategic alliances with selected universities, research institutes, and clinical laboratories, as well as other bio-medical companies both domestically and internationally. The development of these global networks has ensured that high quality, unique products are developed in an effective manner. It is the details involved in the development of one Alfa’s new products, a new DOA saliva test, which is the subject of this article.

Drugs-of-abuse tests for use at point of care are being marketed by companies through out the world. However, most of them are urine-based assays. Lack of privacy and risk of sample alteration are concerns often associated with using urine samples.

Recently, interest in saliva as a diagnostic medium has increased dramatically, as saliva has been shown to reflect tissue fluid levels of therapeutic, hormonal, immunological and toxicological molecules. Furthermore, saliva collection is simple and non-invasive. Saliva can be collected on-site in the presence of witness without compromising the subject's privacy, thus making it difficult to adulterate test results. Drugs present in saliva are mostly unbound parent drug or lipophilic metabolites circulating in the blood. Since these are the forms of the drugs that affect a person’s performance and behavior, saliva is a good specimen in the detection of drug involvement and performance impairment.

However, current saliva-based rapid test devices have their own limitations as well. The interpretation of the test result is not objective because most saliva-based drug test devices, in their present form, are not easily quantifiable. The test procedures are not very user-friendly because they require at least two distinct steps (sample collection, preparation and assay itself) to complete the assay. Collecting samples large enough for confirmation testing is difficult and the accuracy of the test needs further improvement. Further work is also needed to improve the sensitivity and reliability of the assay, particularly for THC (delta9-tetrahydrocannabinol).

For this reason, companies such as Alfa Scientific Designs, Inc. have been working hard to develop a simple one-step saliva-based rapid test for drug of abuse. The test is a lateral flow chromatographic immunoassay for the detection of multiple drugs (MTD, MET, COC, THC, MOR and AMP) in human oral fluid. The test lines are scanned by a portable electronic reader and results are obtained in ten minutes. The remaining sample on the collection pad can be squeezed out in to the collection tube and submitted for a further confirmatory test. Compared with other drug testing devices, the major advantage of Alfa’s product is its ease of use. No additional handling steps are required except collecting of the sample; the assay runs automatically at the end of sample collection. Thus, the test can be easily performed on-site during sample collection.

The first difficulty in the developing the drug testing device was to develop a reliable electronic scanner/reader for the assay. Traditional test strip assay results are interpreted visually making it unsuitable for traffic control applications where the legal-quality data is used by the law enforcement unit to convict the potential offender. Working with our partners, Alfa has built two such prototype readers with a wireless interface which can read color intensity and transmit test results to the station database for legal documentation. The built-in software is capable of adjusting background correction and setting the assay time period for better performance.

The development efforts were complicated by the high viscosity associated with oral fluid which cause slow sample migration. Saliva is an aqueous secretion produced by exocrine glands in the oral cavity. The major macromolecular components of the secretions are networks of high-molecular-mass glycoprotein’s, which make saliva sample viscous. Neither difficulty associated with one-step drug test is the issue of inadvertent negative results for THC. THC is the predominant analyte detected in oral fluid following marijuana ingestion. The detection of THC in oral fluid is very difficult because of the very low concentrations. Furthermore, THC adheres to plastic or glass surfaces and contributes to the false negative test result. Alfa has developed and optimized the test so that the non-specific interaction is minimized.

Alfa’s one-step drug assays system will have clear advantage in road-side check point applications where the reliability of the test and quick assay turn around time is critical. The Alfa one-step system was introduced last summer and to date the tests have been most encouraging.

As a small company, Alfa takes great pride in the quality of the products it has been offering. We are committed to providing our customers with the highest quality products, professional service, and competitive pricing in the IVD industry.

Alfa is very proud of its record as a manufacturer of over 36 FDA 510(k) cleared and CE Marked products in the rapid testing industry, and is constantly looking for new tests that can provide even greater benefits to our customers. The new saliva test is certainly one of these products.

We hope that you have found this discussion on the challenges involved with the development of our new saliva test informative and educational. We welcome this opportunity to introduce Alfa Scientific Designs, Inc. and to explain its product development process.