MedTest Announces Commercial Availability of Four New “Forensic Use Only” Urine Drug Screening Reagents to Its Broad Test Menu

14 Nov 2017
Abigail Berry
Administrator / Office Personnel

Product news

MedTest has announced the commercial availability of four new “Forensic Use Only” urine drug tests for use on its BS-200, BS-480 and BA-800M Chemistry Analyzers. The addition of these products broadens MedTest’s menu of urine drug screening reagents currently available.

The four new assays are: DRI Fentanyl, CEDIA AB-PINACA (Spice K2), CEDIA UR-144/XLR-11 (Spice K2) and DRI Ethyl Glucuronide.

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In the United States, Forensic Use Only products may only be sold to laboratories associated with the criminal justice system as these products have not been cleared by the US Food and Drug Administration (FDA) via the Section 510(k) pre-market notification process. These products are not intended to be used for In Vitro Diagnostic Use and may not be used for medical or diagnostic purposes to identify ailments, dependency or illness. To insure compliance with the FDA regulations for Forensic Use Only products, MedTest will require customers to sign an acknowledgement letter that will be kept on file before these products will be shipped.

Wayne Brinster, CEO of MedTest, stated: “With the emerging focus on the Opioid Crisis in the United States, MedTest is pleased to be able to offer these tests on our scalable chemistry instruments used in criminal justice laboratories. Whether test volume is low or high, MedTest can provide a “right-sized” testing solution that will optimize laboratory operations and provide cost-effective instrument and reagents.”

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The BA-800M analyzer is truly unique compared to other analyzers in its class.  What makes it stand out? Largest Walk-Away Capacity - The BA-800M analyzer offers the Largest Number of Sample Positions: 440 on the BA-800M 580 on the BA-800M2 Most economical reagent consumption - The BA-800M analyzer has the Least Amount of Reagent Consumption - Minimum Reaction Volume is 100 µL. Scalable - Add a 2nd BA-800M system, creating a BA-800M2, to increase sample and through-put capacity to meet growing testing volumes. The BA-800M2 has 2 analytical processers and one Sample Delivery Module. Specialty Test Menu Capable - The BA-800M analyzer accommodates up to 4-reagent testing formats (example - Vitamin D assay).   How does the BA-800M meet the LabORATORY’S Clinical Goals? STAT Function – Fast Lane for STAT Rack on SDM or dedicated STAT positions on sample carousel. Reflexive Testing – Programmable to minimize wait time for results. Confidence in Results – Sample Clot Detection and Reagent Bubble Detection. Specialty Test Menu Capable – Accommodates up to four reagent testing format.   How does the BA-800M meet the LabORATORY’S Operational Goals? Walk-Away Capacity – Largest number of sample positions. Scalable – Add a 2nd BA-800M system to increase sample and through-put capacity. Probe Collision Protection – Auto-Recovery function minimizes operator time.   How does the BA-800M meet the LabORATORY’S FINANCIAL Goals? Reagent Consumption (Tests Per Milliliter Reagent) - 18 out of 19 Drugs of Abuse reagents provide 20 test results per mL of reagent. (The Tricyclic Antidepressants Drug of Abuse reagent provides 13 test results per mL of reagent) Minimum Reaction Volume of 100 μL – Less reagents used per test = lower cost per test = more tests per kit. Special Design of Reagent Bottles – Less dead volume waste. Only available in the USA & Canada

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MedTest Announces Commercial Availability of Four New “Forensic Use Only” Urine Drug Screening Reagents to Its Broad Test Menu