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Gamma-Hydroxybutyric Acid Test

Gamma-Hydroxybutyric Acid Test (Urine) can detect the presence of GHB in human urine orbeverageatconcentrations from 10 μg/mL to 50 μg/mL. The range of detection comparesfavorably with the manufacturer's specified working range shown on device label.

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Description

Intended Use

Parameter	Calibrator	Cut-off (µg/mL)
GHB	Gamma-hydroxybutyric	10

Summary And Explanation

Gamma-hydroxybutyric acid (GHB) is a colorless, odorless chemical and has become one of the most dangerous illicit drugs of abuse today. It has become known as one of the "date rape" drugs and there is an increasing trend that GHB is being used as a recreational drug.

Manufactured lots of GHB test device were tested for sensitivity, assay response range, cross-reactivity, precision and stability. Specifically, the lowest and highest ranges of detectable response were determined. The precision of the assay response between device lots was also examined. The influence of common urine interferants as well as compounds with similar chemical structure was also determined. Stability of the strip response after exposure to high temperatures and moisture in and outside of original packaging was also examined.

The devices appear to have good precision. Within lot precision was within a color scale unit based on the IDS color chart from day to day and between storage containers. The color intensities were also within a color unit between device lots.

The specificity of test strip appears high and will not detect closely related drug structures at concentrations as high as 50μg/mL.

Gamma-Hydroxybutyric Acid Test (Urine) appears to be relatively resistant to common interferants but a strong false positive signal can be produced with extreme concentrations of L-Ascorbic acid. The impact of this interference is expected to be low in human urine or serum as concentrations are expected to be much less. Further titration is required to ascertain at what concentration this effect is observed.

Highly colored samples such as those urines containing high amounts of blood or riboflavin can interfere with interpretation of the color signal. Grossly hemolyzed samples will require clean-up or possibly re-sampling.

Gamma-Hydroxybutyric Acid Test (Urine) reaction zone appears relatively sensitive to moisture. Storage of the devices in the original packaging materials will likely be critical for maintaining stability.

Shelf Life of product is determined to be 9 months from the date of manufacture and will be indicated on the product label.

Test Procedure

The GHB Test Strip (Urine) GHB-U11