Colloidal Gold Urine IVD Morphine MOR Rapid Test Cassette

MOR (Morphine) Gold Rapid Screen Test Cassette

For the Qualitative Detection of MOR in urine

 

Home Use High Accurate Rapid Test For Morphine IVD Qualitative Detection of MOR In Urine

 

Main Features

 

☀ High Sensitivity

 

☀ High Specificity

 

☀ Reliable: high accurate, early detection of the presence of MOR

 

☀ Simple: No Instrument Required

 

☀ Convenient: Room Temperature Storage, Built-In Control line

 

☀ Fast: Results in 5-30 minutes, strong positive results may be observed promptly within 3 minutes

 

☀ Certified by Authoritative Certification System and Standards

 

☀ Winner of "the National Rapid Diagnostic Kit for Clinical Performance Assessment"

 

 

INTENDED USE

 

The MOR Gold Rapid Screen Test Cassette is a rapid qualitative competitive binding immunoassay for determination of Morphine and their metabolites in urine.

 

SUMMARY AND EXPLANATION OF THE TEST

 

The MOR Gold Rapid Screen Test Cassette is a fast and easy to read membrane chromatographic immunoassay with no need for instrument. The method employs a unique combination of monoclonal and polyclonal antibodies to specifically identify Morphine in urine with a high degree of sensitivity.

 

Morphine, one of opiates’ derivatives, is central nervous system stimulants that produce alertness, wakefulness, increased energy, reduced hunger, and an overall feeling of well-being.

 

Morphine has been the preferred drug for the management of pain in cases of advanced cancer and other severe conditions. Morphine and other Opiates’ metabolites may be detected in urine as a result of heroin morphine, codeine, or poppy seed intake.

 

Administration of large doses of Morphine can cause tolerance and physiological dependence in users, and can lead to substance abuse. D-Morphine is controlled substances. GC/MS or immunoassay method has been developed for the determination of 300ng/ml for Morphine.

 

 

REAGENTS AND MATERIALS PROVIDED

 

1. Test Device

A pouched cassette contains a single test for Amphetamine

 

2. Dropper

A transfer pipette seal in foil pouch together with test device

 

3. Operating Instruction

 

 

MATERIALS REQUIRED BUT NOT PROVIDED

 

1. Clock or Timer

2. A container for specimen collection

 

SAMPLE COLLECTION AND PREPARATION

 

Collect a fresh urine sample in a clean, dry container, either plastic or glass, without any preservatives. Urine specimens may be refrigerated (2-8℃) and stored up to 72 hours before testing. Urine samples exhibiting visible precipitates should be filtered, centrifuged or allowed to settle. Use only clear aliquots for testing.

 

 

ASSAY PROCEDURE

 

1. Bring the urine sample and test components to room temperature if refrigerated.

 

2. When ready to test, open the pouch at the notch and remove the test device. Place the test device on a clean, flat surface.

 

3. Fill the urine dropper with specimen. Holding the dropper vertically, dispense 2-3 drops (about 70-100µl) of urine without air bubble into the sample well.

 

4. Read the result in 5-10 minutes.

 

 

Note: There is no meaning attributed to color intensity for C and T lines.

 

WARNING AND PRECAUTIONS

 

1. For in vitro diagnostic use only.

 

2. Do not use kit beyond the expiration date.

 

3. Urine specimens may be infectious; properly handle and dispose of all used reaction devices in biohazard container.

 

STORAGE

 

The kits should be stored at temperature 4-30°C the sealed pouch for the duration of the shelf life (18 months).

 

Performance Characteristics

 

1. Sensitivity.

 

The MOR Gold Rapid Screen Test Cassette is designed for the detection of Morphine and the major metabolite in human urine at the cut-off detection level of 300ng/ml. To verify test sensitivity, a standard panel of MOR was prepared by spiking fresh normal human pooled urine specimens with MOR standard at concentrations of 0, 150, 300 and 600ng/mL. This procedure tested 13 devices per standard level. All samples at concentrations below 300ng/ml tested negative. All samples at concentrations equal to or above 300ng/ml tested positive. The sensitivity of the y.b.t MOR Gold Rapid Screen Test was thus determined to be 300ng/ml. Results per MOR standard concentration are tabulated on the Table below:

 

MOR Gold Rapid Screen Test	MOR Connection (ng/ml)
	0	150	300	600
Qty. Tested	13	13	13	13
Positive	0	0	13	13
Negative	13	13	0	0

 

In the study, negative and positive human urine were tested by three batches MOR Gold Rapid Screen Test Cassette. The Negative and Positive results are 100% accuracy.

 

2. Specificity.

Cross-Reactivity Testing:

 

The MOR Gold Rapid Screen Test Cassette demonstrates no cross-reactivity with following chemical compounds at 100ug/ml.

 

Acetophenetidin	Lidocaine	Acetylsalicylic acid
Methadone	Amitriptyline	Methamphetamine
D-Norpropoxyphene	Codeine	Caffeine
Cocaine	Diamorphine	Diazepam
Marijuana	Ibuprofen	Narceine
Narceine	Amphetamine