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DOA THC One Step Marijuana rapid Test with CE certificate urine uncut sheet
DOA THC One Step Marijuana rapid Test with CE certificate urine uncut sheet
Specifications
Brand Name :
Aichek
Model Number :
MOP-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 :
Professional
Accuracy :
99.9%
Certificate :
CE ISO 13485
Key words :
DOA THC rapid Test with CE certificate urineuncut sheet
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
Description

DOA THC One Step Marijuana rapid Test with CE certificate uncut sheet

Product Name THC One Step Marijuana rapid Test
Formats Strip(3mm)Device(4mm) uncut sheet
Place of Origen China
Specimen Urine
Read Time 5 minutes
Shelf life 2 years
Package uncut sheet
Storage 2℃-30℃

For professional in vitro diagnostic use only.

INTENDED USE

The THC One Step Marijuana Test is a rapid chromatographic immunoassay for the detection of 11-nor-D9 -THC-9 COOH (THC metabolite) in human urine at a cut-off concentration of 50 ng/mL.

Accuracy

A three way side-by-side comparison was conducted using the THC One Step Marijuana Test and a leading commercially available THC rapid test. Testing was performed on specimens previously collected from subjects presenting for Drug Screen Testing. Presumptive positive results were confirmed by GC/MS. The following results were tabulated:

Method

Other THC Rapid Test

Total Results

THC One StepTest

Results

Positive

Negative

Positive

135

1

136

Negative

0

201

201

Total Results

135

202

337

% Agreement with this Rapid Test

100%

99.5%

99.7%

When compared to GC/MS at 50 ng/mL, the following results were tabulated:

Method GC/MS Total Results
THC One StepTest Results Positive Negative
Positive 109 21 130
Negative 2 205 207
Total Results 111 226 337
% Agreement with GC/MS at 50 ng/mL 98.2% 90.7% 93.2%

Analytical Sensitivity

A drug-free urine pool was spiked with 11-nor-D9-Tetrahytrocannabinol-9-carboxylic acid at the following concentrations: 75 ng/mL, 62.5 ng/mL, 37.5 ng/mL, 25 ng/mL, and 0 ng/mL. The result demonstrates 100% accuracy at 50% above and 50% below the cut-off concentration. The data are summarized below:

THC Concentration

(ng/mL)

 Percent of Cut-off n Visual Result
Negative Positive
0 20 20 0
50% 20 20 0
75% 20 9 11
Cut-off 20 3 17
125% 20 3 17
150% 20 0 20

Analytical Specificity

The following table lists compounds and their respective concentrations in urine that yield a positive result in the THC One Step Marijuana Test at 5 minutes.

Compound Concentration (ng/mL)

Cannabinol 20,000

11-nor-D8-THC-9 COOH 30

11-nor-D9-THC-9 COOH 50

D8--THC 15,000

D9-THC 15,000

Precision

A study was conducted at 3 physicians’ offices by untrained operators using 3 different lots of product to demonstrate the within run, between run and between operator precision. An identical panel of coded specimens containing, according to GC/MS, no THC, 25% THC above and below the cut-off, and 50% THC above and below the 50 ng/mL cut-off was provided to each site. For the specimens below the 25 % cut-off concentration, the 3 sites demonstrated 98% agreement with each other. For the –25% to +25% cut-off specimens, the 3 sites demonstrated 83% agreement with each other. For specimens above the 25% cut-off concentration, the 3 sites demonstrated 100% agreement with each other. For all results, the 3 sites were found to have a 92% agreement with each other.

DOA THC One Step Marijuana rapid Test with CE certificate urine uncut sheet

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DOA THC One Step Marijuana rapid Test with CE certificate urine uncut sheet

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Product Detail
Brand Name :
Aichek
Model Number :
MOP-A01
Certification :
CE
Place of Origin :
China
MOQ :
5000 Test
Price :
0.2 USD
Contact Supplier
DOA THC One Step Marijuana rapid Test with CE certificate urine uncut sheet

Hangzhou Aichek Medical Technology Co.,Ltd

Active Member
4 Years
zhejiang, hangzhou
Since 2012
Business Type :
Manufacturer
Main Products :
COVID19 Rapid Test Kit, Antigen Rapid Test Kit, Antibody Rapid Test Kit
Total Annual :
500000-1000000
Employee Number :
150~200
Certification Level :
Active Member
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