The AMP 300 One Step Amphetamine Test Device is a rapid immunochromatographic assay for the qualitative detection of Amphetamine, a central nervous stimulating drug, in urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose.
1. Materials Provided
(1) Test devices
(2) Disposable specimen droppers
(3) Package insert
2. Performance Characteristics Accuracy
(1) A side-by-side comparison was conducted using the AMP 300 One Step Amphetamine Test Device and a leading commercially available AMP 300 rapid test. Testing was performed on 300 clinical specimens. Approximately ten percent of the specimens employed had drug concentrations between –25% and +25% of the cut-off concentration of 300 ng/mL Amphetamine. Presumptive positive results were confirmed by GC/MS. The following results were tabulated:
|Method||Other AMP 300 Rapid Test|
AMP 300 One Step Test Device
|% Agreement with this commercial kit||>99%||>99%||>99%|
(2) When compared at 300 ng/mL cut-off with GC/MS, the following results were tabulated:
|Specimen Cutoff Range by GC/MS|
* * App. 10% negative specimen samples were also confirmed by GC/MS. ** 95% Confidence In
3.Storage and Stability
(1)Store as packaged in the sealed pouch at 2-30°C. The test device is stable through the expiration date printed on the sealed pouch.The test device must remain in the sealed pouch until use. Do not freeze. Do not use beyond the expiration date.
Hangzhou Laihe Biotech Co., Ltd