Drug Of Abuse Rapid Cassette Test-AMP 300 Urine Test Cassette-Colloidal Gold

Drug Of Abuse Rapid Cassette Test-AMP 300 Urine Test Cassette-Colloidal Gold
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Product Details

AMP One Step Amphetamine Test Device


AMP 300.jpg


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

Positive0112123

>99%

(97%-99%)

Negative15018500

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.



Hangzhou Laihe Biotech Co., Ltd

Contact: Helen

Tel: +86-571-86658003

Fax: +86-571-86658000

E-mail: office@lyher.com

Zip:310052



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