Accu-Tell Rapid Multi-Drug Saliva Test (CE)

Specifications One step drug of abuse rapid test kit

CE mark

strip,cassette,multi-drug panel

Specimen:urine or saliva

INTENDED USE Accu-Tell ® One Step Multi-Drug Saliva Test Panel is rapid, qualitative, competitive immunoassay for the determination of Drug-of-Abuse (DOA) and/or their metabolites in human saliva. The device allows the detection of multiple drugs in one simple step. One Step Multi-Drug Screen Test is intended to be used in Professional Medical & Forensic laboratories. This test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrophotometry (GC/MS) is the preferred confirmatory method. Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.     PRINCIPLE OF THE PROCEDURE Accu-Tell® One Step Multi-Drug Saliva Test Panel is a device composed of 2-7 chromatographic strips designed to detect 2-7(as per the format) individual drugs of abuse. Each strip consists of a sample pad treated with antibody colloidal gold conjugate and membrane treated with drug conjugate and control reagent. Saliva sample initially reacts with the antibody gold conjugate, and then migrates up the strip, by capillary action, to the test area. If sufficient drug is present in the saliva, it binds with the conjugate, preventing it from binding to the drug conjugate immobilized on the membrane in the test region. Any unbound conjugate continues to migrate up the strip to the control region where it binds to the control reagent producing a pink/purple band. The control band indicates that the result is valid. A negative specimen produces two (2) distinct color lines, one in the test area and one in the control area. A positive specimen produces only one (1) color line in the control area.   TEST PROCEDURE 1. Bring all materials and specimens to room temperature. 2. Remove test device from the sealed foil pouch. 3. Dispense 80ul of saliva sample by pipette to each sample well of the test device. 4. Read results between 3-8 minutes. Do not interpret results after 8 minutes. INTERPRETATION OF RESULT Positive: One(1) pink/purple band appears in the control region. No band is found in the test region. This is an indication that the drug level is above the detection sensetivity level.   Negative: Two(2) pink/purple bands form. In addition to the control band, a pink/purple band also appears in the test region. Note: This immunoassay is a screening test. A negative result indicates the drug level is below the detevtion sensetivity. It is important to understand that concentrations of the drug below cut off may cause a faint "ghost line" to form in the test region. The "ghost line" should be considered a negative result.   Invalid: If there are no distinct color bands in either the test or control region of the device, the test result is invalid. Retest the sample using a new device. Note: Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when results are positive. Positive results should be confirmed by an alternate method such as GC/MS.   WARNINGS AND PRECAUTIONS Saliva specimens may be infectious. Upon completion of all testing discard the residual saliva in an approved manner. Properly handle and dispose of all used devices in a biohazard container.   PERFORMANCE CHARACTERISTICS Sensitivity Accu-Tell® One Step Multi-Drug Saliva Test Panels have been individually assayed using a comparable reference screen. The compounds detected by this assay have been identified and the levels that produce positive result are listed below. GC/MS testing must be performed to confirm a positive result.   CE, ISO 13485 & ISO 9001 certify, Germany Rheinland TUV certificate.     We have exported our in vitro rapid diagnostic and lab equipment to over 50 countries.   If you need high quality product at competitive price, good after-sale service, good supply chain —— Please contact us without hesitation.       Our Aim:   ——Let every family benefit from our convenient and reliable diagnostic products and services.   ——Let our lab equipment be used in every laboratory of the world.       our Values on Quality:   ——Delivers customer value in all projects, services and processes;   ——Gives quality at least as much consideration as schedules and budgets when day-to-day choices need to be made;   ——Drives QMS results to the bottom line in terms of defect reduction and financial benefits;   ——Allocates resources to achieve quality execution. If you need more information about our products and company, please feel free to contact us anytime.   AccuBioTech Co., Ltd.
USA: 113 Barksdale Professional Center, Newark, DE 19711, USA
China: Building 10, No. 28 Yu Hua Road, Beijing 101300, China Tel: 0086 10 62058220
Fax: 0086 10 62055579 Website: www.accubiotech.com