Abbott A2622.V3 Surestep Multi Drug Screen Cup User Guide

Abbott A2622.V3 Surestep Multi Drug Screen Cup

The information in this presentation is a general overview on performing and interpreting the SureStep™ Drug Screen Cup.

Technical information

For complete instructions, limitations and warnings, please refer to the Package Insert (Instructions for Use) before using this screening device.
The SureStep™ Multi-Drug Screen Cup is a lateral flow chromatographic immunoassay for the qualitative detection of multiple drugs and drug metabolites in urine.
Urine drug screen assay’s 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. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

For in vitro diagnostic use only.

Product Overview

The SureStep™ Drug Screen Cup Overview

Features & Benefits
Integrated test cup screens for 6-8 drugs 6 drugs as per AS/NZS 4308:2008 listed cut-offs. Self-contained cup minimizes exposure to urine Fast results in 5 minutes

IVDBD167-19A
Adulterant Checks 6 panel cup: OX, NIT, S.G, GLUT, pH, CRE IVDBE-187-191
Adulterant Checks 8 panel cup: OX, CRE, pH

TGA ARTG entry is 208049

EDDP

(8Panel)

|

300

BUP

(8Panel)

|

10

Features & Benefits
Integrated test cup screens for 10 drugs Broad clinical screen Self-contained cup minimizes exposure to urine Fast results in 5 minutes

Precautions, storage and stability

Device Storage and Stability:
Store packaged in the sealed pouch at 2-30°C
The tests are stable up to the expiration date printed on the pouch
Test cups must remain in the sealed pouch until use DO NOT FREEZE test devices

Foil Pouch
Lists available tests, storage temperature, lot and expiration date.

A security seal is included in the carton. If required this seal may be used to seal and identify the specimen for laboratory confirmation.

Performing a urine drug screen

Preparation

• Bring cup foil pouch to room temperature before opening.
• Test device must remain in sealed pouch until use.
• Do not use beyond the expiration date.
• Urine specimen can be collected prior to running the test.
• The specimen must be stored in a clean dry container and stored between 2 – 8 ° C for up to 48 hours.
• In order to screen effectively for adulterants, storage of urine specimens should not exceed 2 hours at room temperature or 4 hours refrigerated prior to testing.
• Remove SureStep™ Drug Screen Cup from the foil pouch
• Remove the key by twisting it from the center of the cup cap and then provide urine sample.
• Instruct donor to fill cup to at least 1/3 full.

Note: Desiccant pouches are part of the packaging, they are not a part of the screening device.

Specimen collection procedure (cont.)

• Places the cup on a flat surface and secures the cap tightly by pressing down on the pull tab until an audible click is heard.
• If required place security seal over top and sides of the cup.
• Collector pushes the key to a fully closed position to initiate the test for result interpretation.

Check cup cap for a tight seal.

Place seal over lid and down sides of cup (if required). Push in key to initiate the test.

Urine temperature verification

• A temperature strip is present on the back of the cup that serves as an initial specimen validity check.
• The temperature is read at 2-4 minutes of the donor providing the specimen. Read the green color on the temperature strip.
• A freshly voided specimen will be in the range of 32-38ºC.

Read GREEN colour
Verification of urine temperature to limit sample adulteration, tampering, and dilution is recommended.

Result Interpretation

Interpreting test results

Reading test results

• Technician removes the label from the front of the device to view results.
• If temperature is in a valid range, read Adulterants at 3-5 minutes, read drug test results at 5 minutes.
• The drug test results remain stable for up to sixty (60) minutes.

Peel label to reveal test result window.

Note: For detailed operation instructions, please refer to the package insert or procedure card.

Interpreting specimen validity test

Reading Adulterant test results

Read the adulteration strips between 3-5 minutes.

• Compare the colors of the adulteration pads to the color chart (provided).
• If the results indicate adulteration, do not read the drug test results (or refer to your Drug-Free Policy for guidelines).

SVT Color Chart

Reading drug test results

• Read the drug test results at 5 minutes.
• Do not interpret results after 60 minutes as false results may occur.
• Each test strip within the device includes an internal procedural control (C) that ensures proper device function.
• Control lines should form all control (C) lines, indicating proper functioning of the test device.

Please note that note-illustrations show a generic drug screen. Drugs screened on ANZ devices are as listed previously.

Negative example

Please note that note-illustrations show a generic drug screen. Drugs screened on ANZ devices are as listed previously.

Negative test result

• A colored line appears in the Control region (C) and a colored line appears in the Test region (Drug/T) next to each drug name or number specific drug test.
• Negative results means the drug concentrations in the urine sample are below the designated cutoff levels for a particular drug tested.

Note: Any indication of a colored line, regardless of color intensity, is considered a negative test result.

Presumptive positive example

Presumptive positive test result

• A colored line appears in the Control region (C) and NO line appears in the Test region next to the name or number of a specific drug tested.
• The presumptive positive result means the drug concentrations in the urine sample is greater than the designated cutoff levels for a specific drug.

The test device provides only a qualitative, preliminary analytical results. Gas chromatography chromatography-mass spectrometry (GC -MS) or liquid chromatography chromatography-tandem mass spectrometry (LC-MS/MS) are preferred confirmatory methods.

Invalid example

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 cup.
• If the result is still invalid, contact technical support.

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.

Congratulations!
YOU HAVE COMPLETED THE TRAINING COURSE.

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