Medical In-vitro Diagnostic Urine Drug Screen Test Cup

Product Description
Introduction
The one step cup style drug test is a rapid test based on the principle of immunoassay combined with conjugated colloid gold technology. The tests are designed to obtain a visual, qualitative result and are intended for professional use only. They are not intended for quantitative results, nor for over-the-counter sale.
The drug test provides only preliminary analytical data , A more specific ,alternative method is required to obtain a confirmed analytical result .SAMHSA has established gas chromatography / mass spectrometry (GC/MS) as the preferred confirmatory method. Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive Results are indicated.
Principle
The drug test is a competitive, IVD, immunochromatographic, urinary assay in which a chemically modified and bound drug conjugate competes with urinary MED for limited, specific drug antibody binding sites. The one step cup style drug test has five strips. Each test strip contains a sample reaction unit, a pink-colored, antibody-colloidal gold conjugate unit pre-labeled with specific antibody, and a chromatographic membrane pre-coated with drug conjugate in the device test region.
When free drug is absent from urine or at concentration lower than the urinary detection cut-off level, the pink-colored ,antibody-colloidal gold conjugate is free to bind to the immobilized drug conjugate pre-coated on the chromatographic membrane test region .Consequently ,a pink-colored band will form in the test region indicating a negative result .When drug is present in urine at concentrations at or exceeding the detection cut-off level, it will bind to limited epitopes on the pink-colored, antibody-colloidal gold conjugate , completely competing with drug conjugate in the test region .In such cases , no band forms in the test region ,indicating a positive result.
Sample collection
The fresh urine samples should be collected in a clean, dry container such that same-day testing may be preformed. Urine specimens may be refrigerated at 2-8℃ for 48 hours, or frozen at -20℃ for assaying at a later date .Specimens that have been refrigerated or frozen must be equilibrated to room temperature before testing. Urine samples exhibiting visible precipitates should be filtered, centrifuged or allowed to settle so that clear aliquots can be obtained for testing.
Procedure
1. Review “Specimen collection” instructions. Test device, patient’s samples, and controls should be brought to room temperature (20-30 ℃) prior to testing. Do not open pouches until ready to perform the assay.
2. Remove the test device from its protective pouch (bring the device to room temperature before open the pouch to avoid condensation of moisture on the membrane). Label the device with patient or control number.
3. Get about 1/3 cup of fresh urine samples into the test cup, tight the lid .Then lay it obliquely on a clean, dry, nonabsorbent surface until the strip immerse into the sample.
4. Read the tests result at five minutes.
Interpretation of the results
Negative: Two pink-colored bands appear, one in the control region and one in the test region. A negative result indicates free drug is absent from urine or at concentrations lower than the detection cut-off level of the test.
Positive: One pink-colored band appears in the control region with no apparent band appearing in the test region. A positive result indicates free
drug is present in urine at concentrations at or exceeding the detection cut-off level of the test.
Invalid: No band appears in the control region, or a pink-colored band appears in the test region only. An invalid test result may be due to improper assay procedures or damage to the device. If results are invalid, the assay is inconclusive and the specimen should be re-tested using a new test device.
Note: The band intensity may be weaker or stronger than that of the control band.
Company Information
Voyage Medical Co., Ltd is a professional company specialized in diagnostic rapid test devices and hospital beds. With our own factory, we provide worldwide customers the service of made-to-order manufacturing at competitive prices and good quality. Meet customer’s needs and achieve win-win situation has always been the goal of our efforts.
Our company has strong R & D team, rich experience and strong technical strength. The establishment of a joint laboratory with a number of colleges and universities outside the province, give full play to production, science research, combined the advantages of research focused on quick detection products.
Main Products
At present, voyage has infectious disease detection, tumor marker detection, drug abuse test, pregnancy and eugenics diagnosis and many other series of rapid qualitative diagnosis products, including AIDS, syphilis, hepatitis series test products, home hormone electronic probe, blood glucose test system, immune colloidal gold quantitative detection system, dry quantitative biochemical detection system.
Our Services
Advantage:
1. Popular sell at home and abroad.
2. Nice assessment and feedback.
3. High return rate of single.
After-sales service
Rapid Test Service assurance
Service tenet: quick and decisive and thoughtful thorough and accurate;
Service objectives: service quality to win customer satisfaction;
Service efficiency: the period, we will have a dedicated staff to detect problems with the product for testing, and promptly get back to you;
Service principles: products in the course of product issues caused by improper operation, we will provide a solution.
Packaging & Shipping
To better ensure the safety of your goods, professional, environmentally friendly, convenient and efficient packaging services will be provided.
Related Products
blood glucose meter using strip
Pet Blood Glucose Meter
Pet Blood Glucose Meter StripsFertility&Eugenic Test KitInfectious Disease Test KitLiver Disease Test Kit
FAQ
1.Q:Are you a factory or trading company?
A:We are a trading company with our own factory.
2.Q:Where is your factory located? How can I visit there?
A:Our factory is located in Nantong City, Jiangsu Province, China, near to the Shanghai. You can fly to Shanghai airport directly.All our clients, from home or abroad, are warmly welcome to visit us!
3.Q:What is MOQ?
A: The MOQ depends on different products, generally speaking is 20.000pcs but we can do your requirement.
4.Q:How can I get some samples?
A: We are honored to offer you some free samples.
5.Q:How does your factory do regarding quality control?
A:"Quality is priority. We always attach great importance to quality controlling from the very beginning to the very end. Our factory has gained FSC, ISO13485 and most products have the CE and FDA certificates.
Contact us
If you are interested in our products, pls feel free to contact :
Skype: voyagecathy
Phone: +86 13390986948
QQ: 2867310076
Whatsapp: +86 13390986948
Pls contact Ms Angela