Rapid Buprenorphine Test

Rapid Buprenorphine Test is an immunochromatography based one step in vitro test. It is designed for qualitative determination of Buprenorphine and its metabolites in human urine specimens. This assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/ mass spectrometry (GC/MS) has been established as the preferred confirmatory method by the Substance Abuse Mental Health Services Administration (SAMHSA). Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

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Product Description

Producer:

Xiamen Boson Biotech Co., Ltd

Country of production:

China

Article:

1L04S3

Brief description:

Rapid Buprenorphine Test is an immunochromatography based one step in vitro test. It is designed for qualitative determination of Buprenorphine and its metabolites in human urine specimens. This assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/ mass spectrometry (GC/MS) has been established as the preferred confirmatory method by the Substance Abuse Mental Health Services Administration (SAMHSA). Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

Appointment:

Qualitative determination of Buprenorphine and its metabolites in human urine specimens.

Materials provided:

1. Rapid Buprenorphine Test. The amount of each coated antigen and/or antibody on the strip is less than 1.0 mg for antigen conjugate and is less than 1.0 mg for goat anti-rabbit IgG antibody. Test zone: contains drug bovine protein antigen conjugates Control zone: contains Goat anti-rabbit IgG antibody Conjugate pad: contains anti-drug antibody.
2. Instruction for use.

Materials required but not provided:

1. Urine collection container.
2. Timer or clock

Accuracy:

The accuracy of the Buprenorphine test was evaluated in comparison to GC/MS at a cut-off of 10 ng/ml of buprenorphine-3-β-d-glucoronide. One hundred and one (101) urine specimens which composed of forty nine (49) buprenorphine-3-β-d-glucoronide positive samples and fifty two (52) negative samples were evaluated in this study. The results are summarized as below: Positive % agreement: 96, Negative % agreement: 100.

Sensitivity:

The cut-off concentration (sensitivity level) of the Rapid Buprenorphine Test is determined to be: BUP 10 ng/ml.

Precision:

The precision of Rapid Buprenorphine Test was determined by conducting the test with spiked controls and interpreted the results by three individuals to verify the random error of visual interpretation. The results of 40 samples each of 50% above and 50% below cut-off specimens are 100% agreed by three observers. The test results were found to have no significant differences between these three observers.

Специфічність:

The specificity for Rapid Buprenorphine Test was tested by adding various drugs, drug metabolites, and other compounds that are likely to be present in urine. All compounds were prepared in drugfree normal human urine.

Тип зразка:

urine

Delivery

Implemented by Nova Poshta. If the order is above 1500 UAH, the sender pays the shipping cost

Instructions for use (PDF) Declaration of Conformity (PDF)