A rapid test for the qualitative detection of xylazine in human urine.
For professional in vitro diagnostic use only.
【INTENDED USE】
The Xylazine (XYL) Rapid Test Dipstick (Urine) is a rapid chromatographic immunoassay for the detection of xylazine in human urine at a cut-off concentration of 1,000 ng/mL.
This assay provides only a qualitative, preliminary test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and
professional judgment should be applied to any drug of abuse test result, particularly when
preliminary positive results are used.
【SUMMARY】
Xylazine is a veterinary tranquilizer, which is not approved for human use in the United States, but is commonly used for sedating large animals. Although human intoxication with xylazine has been reported sporadically over the past several decades in a number of case studies.It was also noted in the literature describing drug overdose deaths in Philadelphia as early as 2006, yet it did not appear in high prevalence at that time. However, since the mid-2010 s, xylazine has been noticed by people who inject drugs (PWID) and public health practitioners as an increasingly
commonplace additive in the street opioid supply of Philadelphia. Further, recent reports from connecticut implicated xylazine in a rising fraction of overdose deaths in 2019–2020.1
In Puerto Rico, her/oin is commonly adulterated with xylazine. Also, xylazine is frequently found in speedball (a coc/aine and her/oin mixture). Xylazine has also been reported to be misused as a horse doping agent, a drug of abuse, a drug for attempted sex/ual assault, and as source of
accidental or intended poisonings. From human reported cases, central nervous system depression, respiratory depression, bradycardia, hypotension, and hyperglycemia were observed. Literature shows some similar pharmacologic effects between xylazine and her/oin in humans.2
The Xylazine (XYL) Rapid Test Dipstick (Urine) is a rapid urine-screening test that can beperformed without the use of an instrument. The test utilizes the antibody to selectively detect elevated levels of xylazine in urine. The Xylazine (XYL) Rapid Test Dipstick (Urine) yields a positive result when the xylazine in urine exceed 1,000 ng/mL.
【PRINCIPLE】
The Xylazine (XYL) Rapid Test Dipstick (Urine) is an immunoassay based on the principle of competitive binding. Drugs which may be present in the urine specimen compete against the drug conjugate for binding sites on the antibody.
During testing, a urine specimen migrates upward by capillary action. Xylazine, if present in the urine specimen below 1,000 ng/mL, will not saturate the binding sites of the antibody in the test.
The antibody coated particles will then be captured by immobilized Xylazine-protein conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the Xylazine level exceeds 1,000 ng/mL because it will saturate all the binding
sites of anti-Xylazine antibody.
A drug-positive urine specimen will not generate a colored line in the test line region because of drug competition, while a drug-negative urine specimen or a specimen containing a drug concentration less than the cut-off will generate a line in the test line region. To serve as a procedural control, a colored line will always appear at the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.
