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AMP One Step Amphetamine Test Device

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		Total Results
AMP 300 One Step Test Device	Results	Positive	Negative
	Positive	127	0	127
	Negative	0	173	173
Total Results		127	173	300
% Agreement with this commercial kit		>99%	>99%	>99%

When compared at 300 ng/mL cut-off with GC/MS, the following results were tabulated: 

Specimen Cutoff Range by GC/MS
		Negative	<-25%ofcutoff	-25% cutoff to cutoff	Cutoff to +25%of cutoff	>+25% of  cutoff	% Agreement (95% C.I.)
AMP300   Device	Positive	0	1	1	2	123	>99% (97%-99%)
	Negative	150	18	5	0	0	99%  (96%-99%)

* * 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.