: DA-701 V3.0 版 供體外診斷使用 台塑生醫迅知嗎啡-甲基安非 …

1 - 2 1 formosa One Sure MOP-MET 2 in 1 Rapid test kit P1 For In Vitro Diagnostic 002462 : DA-701 /MDMA - Morphine 3- -D glucuronide Morphine 3- -D glucuronide - 500 ng/ml 300 ng/ml 1.

2 2. 3. 1. Goat anti-mouse-IgG (14%) 2. Morphine-BSA (20%) 3. MAb anti-Morphine CGC (23%) 4. Methamphetamine-BSA (20%) 5. MAb anti-Methamphetamine CGC (23%) 8-30 C 90 l 3 1. 2. 90 l ( ) 3. 5-10 30 Positive : C MET / MOP /MDMA / Negative : ( C MET MOP ) /MDMA C MOP C MET /MDMA Invalid : 1. (5-10 ) 2. ( /MDMA 500 ng/ml 300ng/ml) 3.

3 4. 1. 2. GC/MS 3. 4. 5. 6. codeine, nalorphine, heroine 7. 1. / 500 ng/ml /MDMA 300ng/ml 2. 3. 4. 5. 6. 7. 8. 9. (S) C (C) (T) - 2 1 formosa One Sure MOP-MET 2 in 1 Rapid test kit P2 For In Vitro Diagnostic 002462 : DA-701 (Accuracy) GC/MS - (Specificity) / (ng/ml) D-Methamphetamine 500 L-Methamphetamine 5,000 Mephemterime 50,000 D-Amphetamine 50,000 / (ng/ml) Morphine 300 Codeine 300 Morphine-3- -glucuronide 300 Hydrocodone 5,000 (Precision) (Reproducibility) 1.

4 A. lot to lot reproducibility - 2 1 4 X ( -50%, 250ng/ml) 500ng/ml +50%,750ng/ml 1000ng/ml B. Run to Run variability - 2 1 20 5 X ( -50%, 250ng/ml) 500ng/ml +50%, 750ng/ml 1000ng/ml C. (Operator reproducibility) - 2 1 8 ( -50%, 250ng/ml 500ng/ml +50%, 750ng/ml 1000ng/ml 4 D. (batch consistency) - 2 1 40 ( -50%, 250ng/ml 500ng/ml +50%, 750ng/ml 1000ng/ml 4 2. - 2 1 1. A. lot to lot reproducibility - 2 1 4 X ( -50%, 150 ng/ml) 300 ng/ml +50%, 450 ng/ml 600 ng/ml B.))

5 Run to Run variability - 2 1 20 5 X ( -50%, 150 ng/ml) 300 ng/ml +50%, 450 ng/ml 600 ng/ml 4 C. (Operator reproducibility) - 2 1 8 X ( -50%,150 ng/ml) 300 ng/ml +50%, 450 ng/ml 600 ng/ml 4 D. (batch consistency) - 2 1 40 X ( -50%,150 ng/ml) 300 ng/ml +50%, 450 ng/ml 600 ng/ml 4 2. - 2 1 (Specificity) 100 g/ml - 2 1 Acetaminophen Cocaine hydrochlodride Penicillin G Acetlysalicylic acid Cotinine Phenylpropanolamine Ampicillin Cortisome Quinine Atropine Gentesic acid Salicylic acid Caffeine Glucuronide Thiamine Cannabis Methadone Tryptophan Cocaine Neomycin Tyramine

6 Albumin 20mg/ml Ascorbic acid 10mg/ml glucose 20mg/ml hemoglobin 100 g/ml Thiamine 100 g/ml Uric acid 100 g/ml Urine pH 3 Urine pH 5 Urine pH 7 Urine pH 9 1. Urine Testing for Drugs of Abuse, NIDA Research Monograph 73, (1986). 2. Blum, K., Handbook of Abusable drugs, Gardener Press, Inc., New York, NY, 1st Ed., (1984) 3 0800-211-168 - 50 50 0 0 100 - 2 1 0 0 50 50 100 50 50 50 50 200 100% (50/50) 100% (50/50) 100% (50/50) 100% (50/50) 100% (100/100) 100%(100/100)