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DOA KET One Step Ketamine rapid Test with CE certificate urine uncut sheet

Categories Uncut Sheet Rapid Test
Brand Name: Aichek
Model Number: KET-A01
Certification: CE
Place of Origin: China
MOQ: 5000 Test
Price: 0.2 USD
Payment Terms: T/T
Supply Ability: negotiable
Packaging Details: 40box/carton
Storage: 2℃-30℃
Sample Type: Urine
User: Everyone
Accuracy: 99.9%
Certificate: CE ISO 13485
OEM: OEM customized packing avaliable
Formats: 25T/box 1T/box
After-sales Service: Available
Combo Device: Any 2 To 12 Of The Products Can Be Integrated Into A Combo Cassette
Key words: KET rapid Test with CE certificate urine uncut sheet
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DOA KET One Step Ketamine rapid Test with CE certificate urine uncut sheet

DOA KET One Step Ketamine rapid Test with CE certificate uncut sheet

Product NameKET One Step Ketamine rapid test
FormatsStrip(3mm)Device(4mm) uncut sheet
Place of OrigenChina
SpecimenUrine
Read Time5 minutes
Shelf life2 years
Packageuncut sheet
Storage2℃-30℃

For professional in vitro diagnostic use only.


INTENDED USE

The KET One Step Ketamine Test is a lateral flow chromatographic immunoassay for the detection of Ketamine in human urine at a cut-off concentration of 1,000ng/mL. This test will detect other related compounds, please refer to the Analytical Specificity table in this package insert.


ACCURACY

A comparison was conducted using the KET One Step Ketamine Test and GC/MS at 1,000 ng/mL cut-off. The following results were tabulated:


MethodGC/MSTotal Results

KET One Step

Test

ResultsPositiveNegative
Positive10818
Negative0205205
Total Results10213223
% Agreement100%96.2%96.4%

Analytical Sensitivity

A drug-free urine pool was spiked with Ketamine at the following concentrations: 0 ng/mL, 500ng/mL, 750 ng/mL, 1,000 ng/mL, 1,250 ng/mL and 1,500 ng/mL.The result demonstrates >99% accuracy at 50% above and 50% below the cut-off concentration. The data are summarized below:


Ketamine

Concentration (ng/mL)

Percent of Cut-offnVisual Result
NegativePositive
0020200
500-50%20200
750-25%20155
1,000Cut-off201010
1,250+25%20020
1,500+50%20020

Analytical Specificity

The following table lists compounds that are positively detected in urine by the KET One Step Ketamine Test at 5 minutes.


CompoundConcentration (ng/mL)
Ketamine1,000
Pentobarbital50,000
Secobarbital100,000
Norketamine50,000


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