Drug Abuse Test kits Methamphetamine(MET) Rapid test strip,4mm strip Gold colloidal method,medical or policemen use

Drug Test kits Methamphetamine(MET) Rapid test strip,4mm strip Gold colloidal method,medical or policemen us
 
Specimen: Urine
 
 
Intended Use
 
 
Methamphetamine is an addictive stimulant drug that strongly activates certain systems in the brain. Methamphetamine is closely related chemically to Amphetamine, but the central nervous system effects of Methamphetamine are greater. Methamphetamine is made in illegal laboratories and has a high potential for abuse and dependence. The drug can be taken orally, injected, or inhaled. Acute higher doses lead to enhanced stimulation of the central nervous system and induce euphoria, alertness, reduced appetite, and a sense of increased energy and power. Cardiovascular responses to Methamphetamine include increased blood pressure and cardiac arrhythmias. More acute responses produce anxiety, paranoia, hallucinations, psychotic behavior, and eventually, depression and exhaustion.
The effects of Methamphetamine generally last 2-4 hours, and the drug has a half-life of 9-24 hours in the body. Methamphetamine is excreted in the urine primarily as Amphetamine, and oxidized and deaminated derivatives. However, 10-20% of Methamphetamine is excreted unchanged. Thus, the presence of the parent compound in the urine indicates Methamphetamine use. Methamphetamine is generally detectable in the urine for 3-5 days, depending on urine pH level.
The MET One Step Methamphetamine Test Strip (Urine) is a rapid urine screening test that can be performed without the use of an instrument. The test utilizes a monoclonal antibody to selectively detect elevated levels of Methamphetamine in urine. The MET One Step Methamphetamine Test Strip (Urine) yields a positive result when the Methamphetamine in urine exceeds 1,000 ng/mL.
 

 
 
Test Principle
 

The MET One Step Methamphetamine Test Strip (Urine) is a rapid chromatographic 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. Methamphetamine, if present in the urine specimen below 1000 ng/mL, will not saturate the binding sites of antibody-coated particles in the test strip. The antibody-coated particles will then be captured by immobilized Methamphetamine 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 Methamphetamine level exceeds 1000 ng/mL because it will saturate all the binding sites of anti-Methamphetamine antibodies.
A drug-positive urine specimen will not generate a colored line in the test line region, while a drug-negative urine specimen or a specimen containing a drug in a concentration less than the cut-off will generate a colored 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.
 

DIRECTIONS FOR USE
 

1.  Bring the pouch to room temperature before opening it. Remove the test strip from the sealed pouch and use it as soon as possible.
2.   With arrows pointing toward the urine specimen, immerse the test strip vertically in the urine specimen for at least 10-15 seconds. Do not pass the maximum line (MAX) on the test strip when immersing the strip. See the illustration below.
3.  Place the test strip on a non-absorbent flat surface, start the timer and wait for the red line(s) to appear. The result should be read at 5 minutes. Do not interpret the result after 10 minutes.

 
 
INTERPRETATION OF RESULTS
 
(Please refer to the illustration above)
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 line appearing in the control region
(C) is considered an internal procedural control. It confirms sufficient specimen volume, adequate membrane wicking and correct procedural technique.
Control standards are not supplied with this kit. However, it is recommended that positive and negative controls be tested as good laboratory practice to confirm the test procedure and to verify proper test performance.
 
Performance characteristics
 
Analytical Sensitivity
 
A drug-free urine pool was spiked with Methamphetamine at the following concentrations: 0 ng/mL, 500 ng/mL, 750 ng/mL, 1,000 ng/mL, 1,250 ng/mL, 1,500 ng/mL and 2,000 ng/mL. The result demonstrates > 99% accuracy at 50% above and 50% below the cut-off concentration. Results are presented in Table 2 below.

Table 2: Analytical Sensitivity Summary

 
 
Conclusion: As indicated in table above: all specimens with MET concentration equal to or lower than 500ng/mL show negative results, all specimens with MET concentration of 1000ng/mL are identified as “+/-”, and all specimens with MET concentration equal to or higher than 1500ng/mL showed positive results. Therefore, the cut-off concentration of the MET One Step Test Strip (Urine) is determined to be 1000ng/mL MET.
 
Analytical Specificity
 

Table 3 lists the compounds that are positively detected in urine by the MET One Step Methamphetamine Test Strip (Urine) at 5 minutes and the concentrations at which they are detected.

Table 3: Analytical Specificity