PRODUCT INFORMATION AND FEATURES: REQUIRES URINE SAMPLE TESTS FOR: – AMPHETAMINES – METHAMPHETAMINES – MORPHINE – COCAINE – TETRAHYDROCANNABINOL (MARIJUANA) FEATURES: • MEETS SAMHSA REQUIREMENTS / U.S. FDA 510(K) CLEARED • 99% ACCURACY LEVELS / FAST AND ACCURATE RESULTS • CLEAR INSTRUCTION / EASY-TO-READ PANEL • LONG SHELF LIFE (12-18 MONTHS)
PRODUCT INFORMATION AND FEATURES: TEST PROCEDURE THE TEST PROCEDURE CONSISTS OF ADDING THE URINE SAMPLE TO THE SAMPLE WELL OF THE DEVICE AND WATCHING FOR THE APPEARANCE OF COLORED LINES IN THE RESULT WINDOW. TEST PROTOCOL TEST PROTOCOL 1. FOR EACH TEST, OPEN ONE ACCUSIGN® THC POUCH THC AND LABEL THE ACCUSIGN® DEVICE WITH THE PATIENT ID. 2. HOLDING THE DROPPER VERTICALLY, DISPENSE 3 DROPS (110ΜL) OF THE URINE SAMPLE INTO THE SAMPLE WELL (S). 3. READ THE RESULT AFTER 3 MINUTES, BUT WITHIN 10 MINUTES. INTERPRETATION OF RESULTS NEGATIVE: THE APPEARANCE OF A REDDISH-PURPLE CONTROL LINE (C) AND A LINE NEXT TO T INDICATES A NEGATIVE TEST RESULT; I.E., NO DRUG ABOVE THE CUTOFF LEVEL HAS BEEN DETECTED. THE COLOR INTENSITIES OF THE CONTROL LINE AND THE TEST LINE MAY NOT BE EQUAL. ANY FAINT TEST LINE IN THE RESULT WINDOW, VISIBLE IN 10 MINUTES, SHOULD BE INTERPRETED AS NEGATIVE. A NEGATIVE TEST RESULT DOES NOT INDICATE THE ABSENCE OF DRUG IN THE SAMPLE; IT ONLY INDICATESDURAL CONTROL. A DISTINCT REDDISH-PURPLE CONTROL LINE SHOULD APPEAR AT THE CONTROL POSITION IN THE RESULT WINDOW, IF THE TEST PROCEDURE IS PERFORMED PROPERLY, AN ADEQUATE SAMPLE VOLUME IS USED, THE SAMPLE AND REAGENT ARE WICKING ON THE MEMBRANE, AND THE TEST REAGENTS AT THE CONTROL LINE AND THE CONJUGATE-COLOR INDICATOR ARE REACTIVE. IN ADDITION, IF THE TEST IS PERFORMED CORRECTLY AND THE DEVICE IS WORKING PROPERLY, THE BACKGROUND IN THE RESULT WINDOW WILL BECOME CLEAR AND PROVIDE A DISTINCT RESULT. THIS MAY BE CONSIDERED AN INTERNAL NEGATIVE PROCEDURAL CONTROL. THE POSITIVE AND NEGATIVE PROCEDURAL CONTROLS CONTAINED IN EACH ACCUSIGN® THC TEST DEVICE SATISFY THE REQUIREMENTS OF TESTING A POSITIVE CONTROL AND A NEGATIVE CONTROL ON A DAILY BASIS. IF THE CONTROL LINE DOES NOT APPEAR AT THE CONTROL POSITION IN THE RESULT WINDOW, THE TEST IS INVALID AND A NEW TEST SHOULD BE PERFORMED. IF THE PROBLEM PERSISTS, CONTACT PBM FOR TECHNICAL ASSISTANCE. EXTERNAL CONTROL: EXTERNAL CONTROLS MAY ALSO BE USED TO ASSURE THAT THE REAGENTS ARE WORKING PROPERLY AND THAT THE ASSAY PROCEDURE IS FOLLOWED CORRECTLY. IT IS RECOMMENDED THAT A CONTROL BE TESTED AT REGULAR INTERVALS AS GOOD LABORATORY TESTING PRACTICE. FOR INFORMATION ON HOW TO OBTAIN CONTROLS, CONTACT PBM’S TECHNICAL SERVICES.