T R A I N I N G G U I D E

Transcription

1 TRAINING GUIDE

2 InstaCube Oral Fluid Drug Test For Forensic Use Only Powered By:

3 Contents 3 The information in this presentation is a general overview on performing and interpreting the InstaCube Oral Fluid Drug Test screening device. Product Training Contents: Technical information Product overview Performing a saliva drug screen Result interpretation Additional support services

4 Technical Information 4 For complete instructions, limitations and warnings, please refer to the Package Insert (Instructions for Use) before using this screening device. These tests provide visual qualitative results and are intended for in vitro diagnostic use only. The InstaCube Oral Fluid Drug Test is available in single drug analyte format. It is intended for Forensic Use Only. Saliva drug screen assays provide 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) or liquid chromatography-tandem mass spectrometry (LC-MS/MS) are the preferred confirmatory methods.

5 Product Overview

6 Overview 6 This training may be used with InstaCube Oral Fluid Drug Test (Forensic Use Only). For Forensic Use Only Saliva test targets up to 12 illicit and prescription drugs Simple procedure: collect, insert, and read results Convenient and non-invasive rapid onsite screening Eliminates need for cross gender observation Reduces sample adulteration or contamination

7 Abbreviations and Cutoff Level Concentrations 7 Test Calibrator Cut-off (ng/ml) Test Calibrator Cut-off (ng/ml) Amphetamine (AMP) D-Amphetamine 50 Phencyclidine (PCP) Phencyclidine 10 Cocaine (COC) Benzoylecgonine 20 Oxycodone (OXY) Oxycodone 20 Marijuana (THC) 11-nor-Δ9-THC-9 COOH 12 Benzodiazepines (BZO) Oxazepam 10 Methamphetamine (MET, mamp) D-Methamphetamine 50 Buprenorphine (BUP) Buprenorphine 5 Opiate (OPI) Morphine 40 Barbiturates (BAR) Secobarbital 50 Methadone (MTD) Methadone 30 Alcohol (ALC) Alcohol >0.02% B.A.C The cut-off level is the specified concentration at which a drug/metabolite can be detected in a sample. Above that concentration, the test is called a presumptive positive, and below that concentration, it is called negative.

8 Marijuana In Oral Fluid (Saliva) 8 Marijuana is an exception and different from other drugs in how its use is captured in an oral fluid test. The following apply to oral fluid testing for Marijuana: The oral fluid test only picks up residue of Marijuana trapped in the mouth from recent use because the metabolite or parent drug concentrations in Marijuana do not cross into oral fluid collectors Presumptive positive test results for Marijuana in oral fluid reflect very recent usage within the last 3 hours to 1 day Drug test results for Marijuana can be different between an oral fluid test and a urine test because the oral fluid test only detects recent Marijuana usage from residue and a urine test is based on a metabolite which takes at least 4 hours, often longer, to get processed though the body s internal organs into the urine

9 Precautions, Storage and Stability 9 Precautions: Device storage and stability: For in vitro diagnostic use For forensic use only The test is for one time use only Do not use after the expiration date The test device should remain in the sealed pouch until use The used test device should be discarded according to federal, state and local regulations Do not use this test if you are color-blind Safety data sheets available for professional user upon request Store packaged in the sealed pouch at F (15-30 C) The tests are stable through the expiration date printed on the pouch Product title Lists available tests Lot # EXAMPLE INFORMATION Instacube THC50/COC300/AMP1000/MAMP1000/BAR300/ BZO300/MOP/PCP25/MTD300/OXY100 Lot: D Exp: Expiration date

10 Performing a Saliva Drug Screen

11 Performing a Saliva Drug Screen 11 Specimen storage and preparation: The oral specimen should be collected using the collector provided with the kit. No other collection devices should be used with this test Oral fluid collected at any time of day may be used For best results, test specimens immediately following collection Please refer to package insert if specimen cannot be tested immediately

12 Performing a Saliva Drug Screen 12 Gather all necessary testing supplies: Materials provided 1 step-by-step test instruction (package insert) 25 collectors 25 test devices Security seals Alcohol color chart (if applicable) Recommended but not provided Timing device (timer, clock, watch, etc.) Disposable gloves

13 Performing a Saliva Drug Screen 13 InstaCube Oral Fluid Drug Test foil pouch (example): The foil pouch contains the following information: list of drugs screened, part number, lot #, and expiration date. Make sure test device is at room temperature before opening Test device must remain in sealed pouch until use Do not use beyond the expiration date

14 Performing a Saliva Drug Screen 14 Specimen collection procedure: Instruct donor on proper procedure for saliva collection. Warnings and precautions Prior to testing, DO NOT place anything in the mouth for at least 10 minutes. This includes: Food Gum Drink Tobacco products Any other substance or material

15 Performing a Saliva Drug Screen 15 Specimen collection procedure (cont.): Have donor select the device Donor should give the sealed test to the collector to record lot # and expiration date Collector records lot # and expiration date information, then returns device to donor Note: Collector should not handle the test device again until specimen is collected and the collector is ready to begin testing. EXAMPLE INFORMATION

16 Performing a Saliva Drug Screen 16 Specimen collection procedure (cont.): 1. Remove the test device from the sealed pouch and use it as soon as possible 2. Remove the collector from the sealed pouch, insert the sponge into mouth. Close mouth and continuously move the sponge around for oral fluid collection. Soak sponge in oral fluid and swab the inside of the mouth and tongue Collect oral fluid for 7 minutes OR until sponge is soft and fully saturated No hard spots should be felt on sponge when saturated DO NOT suck, bite, or chew on sponge as proper collection may not occur

17 Performing a Saliva Drug Screen 17 Specimen collection procedure (cont.): Donor returns collected specimen back to collector 1. Place the test device on a clean and flat surface 2. Remove the collection sponge from the mouth and GENTLY insert the sponge into the screening device, press until the collector cap is sealed with the device tightly Keep upright on a flat surface when gently inserting and pressing the sponge 3. Peel off label and wait for the colored signal to appear in the test results area If there is no flow within 1 minute after completing step 2 (above) please refer to the troubleshooting guide in additional support services section

18 Result Interpretation

19 Interpreting Test Results 19 Reading the results: Keep upright and on a flat surface while test is running Peel off the label to view results If your product has Alcohol (ALC) read ONLY alcohol results at 3 minutes Read Results at 10 minutes. Do not interpret after 15 minutes Note: For detailed operation instructions, please refer to the package insert or procedure card.

20 Interpreting Alcohol Test 20 Reading alcohol test results: If applicable Read at 3 minutes Negative Result: The alcohol pad shows no color change (remains white or cream colored); it should be interpreted as a negative result (no alcohol present) Invalid Result: The outer edges of the alcohol pad produces a slight color but the majority of the pad remains colorless should be repeated to ensure complete saturation of the alcohol pad with oral fluid If the second result is the same, the result should be interpreted as being negative (no alcohol present) Positive Result: The alcohol tests produces a color change to green to blue in the presence of salivary alcohol 0.02% B.A.C. or higher. At higher alcohol concentration near 0.30% B.A.C the color may change to a dark blue-gray

21 Interpreting Drug Test Results 21 Reading drug test results: Read Results at 10 minutes. Do not interpret after 15 minutes Each test strip within the device includes an internal procedural control (C) that ensures proper device function Control lines should form on all control (C) lines, indicating proper functioning of the test device

22 Negative Example 22 Negative test result: A colored line appears in the Control region (C) and a colored line appears in the Test region (T) next to each drug name Negative results means the drug concentrations in the saliva sample are below the designated cutoff levels for a particular drug tested CONTROL LINE TEST LINE Note: Any indication of a colored line, regardless of color intensity, is considered a negative test result.

23 Presumptive Positive Example 23 Presumptive positive test result: A colored line appears in the Control region (C) and NO line appears in the Test region (T) next to the name The presumptive positive result means the drug concentrations in the saliva sample is greater than the designated cutoff levels for a specific drug CONTROL LINE TEST LINE The test device provides only qualitative, preliminary analytical results. Gas chromatographymass spectrometry (GC-MS) or liquidchromatography-tandem mass spectrometry (LC-MS/MS) are preferred confirmatory methods.

24 Invalid Example 24 Invalid test result: 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 device CONTROL LINE TEST LINE If the result is still invalid, contact customer support

25 Interpretation of Results 25 NEGATIVE The control line must be colored to indicate the test is valid. Any visible line, even a faint line, indicates a negative result. PRESUMPTIVE POSITIVE The control line must be colored to indicate the test is valid. The test area must be snow white to be considered positive. Additional testing is necessary to confirm the presumptive positive results. Positive results should be confirmed by an alternate method such as GC-MS or LC-MS/MS. INVALID When there is no line in the control line area, the result is invalid. If an invalid result is obtained repeat the test using a new test device.

26 Additional Support Services

27 Test Limitations 27 Instant saliva (oral fluid) tests provide only a qualitative, preliminary analytical result. A secondary analytical method must be used to obtain a confirmed result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method There is a possibility that technical or procedural errors, as well as other interfering substances in the saliva specimen may cause erroneous results A positive result does not indicate level or intoxication, administration route or concentration in saliva A negative result may not necessarily indicate drug-free saliva. Negative results can be obtained when drug is present but below the cut-off level of the test The test does not distinguish between drugs of abuse and certain medications A positive result might be obtained from certain foods or food supplements

28 Troubleshooting Guide 28 Insufficient Saliva (collection device is not completely softened/saturated) CAUSE: Interfering substance, collection time, or dehydration Confirm donor has not had any food, drink, gum, tobacco products or other substance in their mouth at least 10 minutes prior to collection Ensures that neat saliva has been collected and that no substance interferes with collection or wicking process Make sure donor collects oral fluid for 7 minutes OR until sponge is soft and fully saturated No hard spots should be felt on sponge when saturated Allow donor to have a drink water and retest at least 10 minutes later In rare instances a donor may be dehydrated and unable to produce sufficient saliva needed for collection No Flowing (saliva not wicking on test strips) CAUSE: Failure of saliva flow or wicking properly can be caused by insufficient sample volume, extremely viscous saliva, or an air bubble blocking the flow. Confirm there is sufficient saliva (see above) and that the donor DID NOT suck, bite, or chew on the sponge during collection Insufficient sample volume or improper collection may have occurred Move device back and forth on a flat surface several times; keep vertical (Do not tilt during the whole process) Saliva may be extremely viscous or an air bubble may be blocking the flow Gently remove the collector cap and gently reseal tightly Saliva may be extremely viscous or an air bubble may be blocking the flow

29 Troubleshooting Guide (Cont.) 29 Flooding (collection device is over saturated) CAUSE: Excess saliva to the membrane causes the normal reaction to be circumvented. Test strips will be saturated but no lines form next to the control and or test lines Donor should stop collection once device is completely saturated Collection device will become soft and flimsy indicating device is completely saturated Keep upright (vertical) on a flat surface when Gently Inserting the sponge and while the test is running. Test was not placed vertically on a flat surface causing flooding on the test strips

30 CONGRATULATIONS!!! You have completed the training course For additional information or assistance with this device contact Customer Support at