multiple cassette 6 panel Drug Testing kits Saliva, Saliva Specimen, High Accuracy, easily and quick,

Intended Use

The Oral Fluid Drug Screen Device for AMP/MET/COC/OPI/THC/BZO is a lateral flow chromatographic immunoassay for the qualitative detection of amphetamine, methamphetamine, cocaine, opiates, THC, BZO and their metabolites in oral fluids at the following cut-off concentrations:

This assay provides only a preliminary analytical 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) and gas chromatography/tandem mass spectrometry (GC/MS/MS) are the preferred confirmatory methods. Professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

DIRECTIONS FOR USE

Allow the test, urine specimen, and/or controls to reach room temperature

(15-30ºC) prior to testing.

1. Specimen Collection
2. Using the provided oral fluid swab, sweep the inside of the mouth for 3 minutes. The sponge will gradually soften as oral fluid is absorbed, and should be completely soft after 3 minutes.
3. Stop sweeping the mouth, and push the moistened swab firmly into the specimen dispenser. Push the collector into the collection chamber and press down firmly to release as much liquid as possible. Be sure that at least 0.5 mL liquid has been collected in order to make re-confirmation test possible, if necessary.
4. Tightly shut the outer cap of the specimen dispenser.
5. Test Procedure
6. Remove the test from its sealed pouch, and place it on a clean, level surface. Label the test with patient or control identification. For best results, the assay should be performed within one hour.
7. Unscrew the dispensing tip (not the outer cap) of the specimen dispenser, and transfer 3 drops of fluid (approximately 100 µL) to each specimen well (S) of the device and start the timer.
8. Avoid trapping air bubbles in the specimen wells (S), and do not add any solution to the result areas.
9. As the test begins to work, color will migrate across the membrane. 10. Wait for the colored band(s) to appear. The result should be read at 10 minutes. Do not interpret the result after 20 minutes.

INTERPRETATION OF RESULTS

NEGATIVE:* Two lines appear. One colored line should be in the control region (C), and another apparent colored line adjacent should be in the test region (Drug/T). This negative result indicates that the drug concentration is below the detectable level. *NOTE: The shade of color in the test line region (Drug/T) will vary, but it should be considered negative whenever there is even a faint line.

POSITIVE: One colored line appears in the control region (C). No line appears in the test region (Drug/T). This positive result indicates that the drug concentration is above the detectable level. INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test using a new test panel. If the problem persists, discontinue using the lot immediately and contact the 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.

Established in 2009, Orient New Life Medical Co., Ltd., is specialized in high-tech biological diagnostic test development, research and production, as well as high-tech medical device development, research and production. New Life has built up two production base, which produce biological diagnostic test and endoscopic medical device respectively. Our products ranged in the following specialties: drug of abuse tests, fertility tests, infectious diseases tests, sexual transmitted diseases tests, tumor markers tests, cardiac markers tests, veterinary tests, and surgical stapler series.

NEW LIFE have 3 wholly-owned and joint stock subsidiary companies, including Orient New Life Medical  Co., Ltd., Orient Gene Biotech Co., Ltd., Qianjing Medical Equipment Co., Ltd.

Company's core technical team with more than 35 employees，3 doctors and 25 masters. They have many years of famous universities in the United States and pharmaceutical companies engaged in the project research and development, production and marketing, business management experience.Company owns hundreds of grade purification workshop and all level of quality checkout room, equipped with various production and testing equipment.