Urine CARD 4MM GHB Rapid Test Cassette Cut - Off 10 μG/ML 5-15 Minu

high sensitivity Drug Abuse Test Kit ) GHB Rapid Test 4mm cassette , cut-off 10 μg/mL

Product Name

GHB Rapid Diagnostic Test

Specimen: Urine

Intended Use

The GHB Rapid Test Cassette is a rapid biochemical-based assay to detect the presence of GHB in urine and provide a presumptive result for presence of GHB in urine at concentrations above 10 μg/mL. This test provides a preliminary result only. A more specific alternate chemical method is recommended. Gas chromatography/mass spectroscopy (GC/MS) is the preferred confirmation method. Clinical consideration and professional judgment should be applied to any test result, particularly when preliminary positive screens are indicated.

Test Principle

GHB-DH catalyses the reaction of GHB and NAD to produce NADH, and a diaphorase couple tetrazoliym dye reaction results in the production of a purple dye complex. The reagents were stabilized and used to produce the test to screen for GHB in urine at 10 μg/mL.

DIRECTIONS FOR USE

Bring tests, specimens, and/or controls to room temperature (15-30°C) before use.

Remove the test from its sealed pouch, and place it on a clean, level surface. Label the test with patient or control identification. For best results, the assay should be performed within one hour.

Using the provided disposable pipette, transfer 3 drops of specimen (approximately 120 µL) to the specimen well (S) of the device and start the timer.

Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result area.

As the test begins to work, color will migrate across the membrane.

Wait for the colored band(s) to appear. The result should be read at 5 minutes. Do not interpret the result after 8 minutes

INTERPRETATION OF RESULTS

NEGATIVE:* A colored line appears in the Control region (C) and colored lines appears in the Test region (T). This negative result means that the concentrations in the urine sample are below the designated cut-off levels for a particular drug tested.

*NOTE: The shade of the colored lines(s) in the Test region (T) may vary. The result should be considered negative whenever there is even a faint line.

POSITIVE: A colored line appears in the Control region (C) and NO line appears in the Test region (T). The positive result means that the drug concentration in the urine sample is greater than the designated cut-off for a specific drug.

INVALID: No line appears in the Control region (C). Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for Control line failure. Read the directions again and repeat the test with a new test card. If the result is still invalid, contact your manufacturer.

QUALITY CONTROL

A procedural control is included in the test. A colored line appearing in the control line region (C) is considered an internal procedural control. It confirms sufficient specimen volume, adequate membrane wicking and correct procedural technique.

performance characteristics

A side-by-side comparison was conducted using the GHB Rapid Test Cassette (Urine) and GC/MS. The following results were tabulated:

Table 1: Specimen Correlation

Established in 2009, Orient New Life Medical Co., Ltd., is specialized in high-tech biological diagnostic test development, research and production, as well as high-tech medical device development, research and production. New Life has built up two production base, which produce biological diagnostic test and endoscopic medical device respectively. Our products ranged in the following specialties: drug of abuse tests, fertility tests, infectious diseases tests, sexual transmitted diseases tests, tumor markers tests, cardiac markers tests, veterinary tests, and surgical stapler series.

NEW LIFE have 3 wholly-owned and joint stock subsidiary companies, including Orient New Life Medical  Co., Ltd., Orient Gene Biotech Co., Ltd., Qianjing Medical Equipment Co., Ltd.

Company's core technical team with more than 35 employees，3 doctors and 25 masters. They have many years of famous universities in the United States and pharmaceutical companies engaged in the project research and development, production and marketing, business management experience.Company owns hundreds of grade purification workshop and all level of quality checkout room, equipped with various production and testing equipment.