Innovative Urinalysis Test Strips with ID bands

The latest innovation for the MULTISTIX® family of urinalysis test strips; the addition of identification (ID) bands.

Innovative Urinalysis Test Strips with ID bands

The ID bands will trigger important automatic checks (Auto-Checks) when used with the following CLINITEK® analyzers:
CLINITEK Status®+ Analyzer version 2.0 or greater
CLINITEK Status® Analyzer upgraded with software version 2.0 or greater
CLINITEK Status® Connect System
CLINITEK Advantus® Analyzer version 3.0 or greater

 

As of September 1, 2013 the above analyzers will activate an automatic quality check that ensures only results from validated Siemens urinalysis strips will be reported. As part of Siemens’ urinalysis automatic checks (Auto-Checks) capabilities, this activation will prevent errors that may occur when nonvalidated urinalysis strips are used on the above analyzers, since their performance on these analyzers cannot be guaranteed.

If you are using any of the analyzers listed above with the Siemens urinalysis strips listed below, the Auto-Checks feature is already enabled and there is nothing further you need to do. Your analyzers will continue to perform as expected. However, as of September 1, 2013, if you are using any of the analyzers listed above with urinalysis strips that are not listed below, the analyzer will generate an E50 error and results will not be reported.
 

Benefits of Auto-Checks
The analyzers listed above have new software that recognizes the ID bands and provides the following Auto-Checks for improved workflow, results integrity and clinical information for the busy office or laboratory:

  • Minimizes false-positive results with automatic notification if test strip has been degraded from humidity, preventing potentially erroneous patient results from being reported.*
  • Enables user compliance with IVDD regulations by reporting results only from urinalysis strips that have been validated for use on the CLINITEK Status analyzers.
  • Provides printed sample interference notes when common sample interferences are detected, providing healthcare professionals additional clinical information to aid in patient management.**
  • Eliminates the need to manually select strip type if using different urinalysis strips – saves time and reduces possible errors.

* Only available with Siemens test strips that have the leukocyte pad
**Feature not available in the U.S.
 

The new test strips can be used on Siemens’ CLINITEK® 50, CLINITEK® 100, CLINITEK Status® (software versions 1.900 and earlier), CLINITEK® 500 and CLINITEK Advantus® analyzers version 2.0 or earlier, without impacting performance. However, since these analyzers do not recognize the ID bands, the Auto-Checks features are not available. CLINITEK Advantus® Analyzers with versions 3.0 or greater will have Auto-Checks enabled.
 

Siemens is committed to continuous innovation in urinalysis and providing our customers with solutions for improved workflow and improved clinical information at the point of care.
 

Dip It Right!
It is important to continue to use the proper dipping and test strip handling techniques to optimize results.

For visual users

Dip It Right!
If reading the test strips with identification (ID) bands visually, continue to use the proper handling technique stated in the product labeling to optimize test processing:

  1. Do not touch any of the test pads, including the ID band.
  2. Follow the proper dipping technique:
  • Dip all the tests pads fully in the sample.
  • Note: The ID bands can be dipped if proper dipping technique is used.
  • Drag the edge of the strip against the container rim to remove excess urine.
  • Compare each test pad to the corresponding row of color blocks on the bottle label

 

(Do not align the white ID band with the color blocks on the bottle label for result interpretation)

Dip It Right! It is important to continue to use the proper dipping and strip handling technique in order to optimize the test processing:

  1. Do not touch any of the test pads, including the ID bands
  2. Follow the proper dipping technique
  • Dip (1) strip in urine sample. Wet all pads.
  • Quickly remove strip from urine.
  • Drag (2) the edge of the strip against the side of the sample container as you remove it.
  • Blot (3) by touching the edge of the strip to a paper towel to remove excess urine.
  • Place (4) strip in channel of table with pads facing up.
  • Slide or push strip to end of the channel. Do not touch the pads on the test strip.

Note:
The ID band can be dipped if proper dipping technique is used.
 

Dip It Right! It is important to continue to use the proper dipping and strip handling technique in order to optimize the test processing:

  1. Do not touch any of the test pads, including the ID bands.
  2. Follow the proper dipping technique.
  • Dip (1) strip in urine sample. Wet all pads Note: The ID band can be dipped if proper dipping technique is used.
  • Quickly remove test strip from sample.
  • Drag (2) the edge of the strip against the side of the container rim to remove excess urine.
  • Place test strip onto the strip loading area of the analyzer.

 

Menu*:
The following Siemens urinalysis test strips have the ID band.

CLINITEK® Microalbumin 2 MULTISTIX® SG
CLINITEK® Microalbumin 9 MULTISTIX PRO® 10LS
Combistix® SG N-MULTISTIX® SG
Hemacombistix® N-MULTISTIX® SG L
Labstix® SG N-Neostix®
MULTISTIX® 10 SG Uro-Hemacombistix® SG L
MULTISTIX® 8 SG Uro-Hemacombistix®
MULTISTIX® 7 Uristix®
MULTISTIX® 5 Uristix® 4
MULTISTIX® GP Uro-Uristix®

*Note Not all urinalysis strips are available in all countries. Contact your local Siemens sales representatives for more information.

CLINITEK Status Analyzers with software version 1.9 or lower will not provide the Auto-Checks features.

All test strips can be read visually, except for MULTISTIX PRO 10 LS, CLINITEK Microalbumin 2 and CLINITEK Microalbumin 9.
 

For the most up-to-date product insert, visit the Document Library


Quality Control Materials for Optimal Performance
The urine controls listed have been used successfully by customers with ID banded urine test strips. The expected results for these strips can be found in the QC product insert supplied by the manufacturers.
 

Note: Cleared for use in CLIA waived and CLIA moderately complex sites.

Dipper Style

Quantimetrix Dipper™ Dipstick Control

Part number: 1440-01
Description: Level 1 and 2 Set 6 x 15 mL

Part number: 1442-61
Description: Level 2 (positive) 6 x 15 mL

Bio-Rad qUAntify® Plus Control, Bi-level

Part number: 995
Description: 10 x 12 mL tubes

Part number: 995X
Description: 2 x 12 mL tubes (Mini Pack)

Part number: 962
Description: 4 x 120 mL

Part number: 962X
Description: 2 x 120 mL (Mini Pack)

Part number: 963
Description: Level 1 (negative) 4 x 120 mL

Part number: 964
Description: Level 2 (positive) 4 x 120 mL

Dropper Style

Dropper style controls should only be used if the control is transferred to an appropriate test tube before use.
Applying a drop of control to the top of a test pad does not ensure optimum performance for each reagent. Do not drop control solution onto the ID band. To ensure optimum performance refer to “Proper dipping techniques for Siemens urinalysis test strips” above.

Quantimetrix Dropper Plus POC Urine Dipstick Control Set

Part number: 1440-04
Description: 10 x 5 mL

Kenlor Liquid Urine Dipstick Control

Part number: 210303
Description: Negative, 6 x 10 mL

Part number: 210304
Description: Positive, 6 x 10 mL

Part number: 210306
Description: Negative and Positive 3 x 10 mL


Note: This information does not apply to CLINITEK Atlas® or CLINITEK® AUWi™ System users

 

Siemens Chek-Stix

Product number*
Description: Combo Pak, Negative and Positive 25 x 12 mL

Product number*
Description: Positive 25 x 12 mL

HYCOR KOVA®-Trol

Product number: 87329
Description: KOVA-Trol I High Abnormal 4 x 15 mL

Product number: 87332
Description: KOVA-Trol I High Abnormal w/ Urobilinogen, 4 x 15 mL

Product number: 87130
Description: KOVA-Trol II Low Abnormal 4 x 15 mL

Product number: 87331
Description: KOVA-Trol III Normal w/ hCG, 4 x 15 mL

 

 

* Contact your Siemens representative for product codes
 

Note: This information does not apply to CLINITEK Atlas® or CLINITEK® AUWi™ System users

What are ID bands?
ID bands are white or colored areas located near the handle of Siemens Urinalysis Strips that enable automatic quality checks (Auto-Checks) when reading the strips on selected CLINITEK® instruments.

Will the ID band affect reported urinalysis results?
No, the ID band is not used in the calculation of individual urine test results.

Does the analyzer detect humidity over-exposure on all ID-banded strips?
No. The leukocyte pad is used to determine if the strip has been degraded from exposure to humidity. Only those Siemens strips with the leukocyte pad can detect humidity over-exposure.

Is it possible to get a strip identification error on CLINITEK instruments?
Yes, if too much liquid is left on the ID band area. Dip It Right! Using the proper dipping technique greatly reduces the likelihood of these errors.

Can ID banded strips be used with any CLINITEK analyzer?
Yes, all except CLINITEK Atlas® System and CLINITEK® AUWi™ systems. Also, the Auto-Checks capabilities are only enabled with CLINITEK Status+ analyzers, CLINITEK Status analyzers with software version 2.0 and higher, and CLINITEK Status Connect System.

Why did Siemens put ID bands on the urinalysis strips?
The ID bands are added to improve the quality of results and to streamline workflow. 

Why does Siemens say to NOT touch the ID bands?
The ID bands have a hydrophobic (water repellent) coating that helps to prevent build-up of liquid. Touching this band may disrupt the coating and allow more fluid to collect on the band. This can cause a strip identification error. As stated in the product insert, test pads, including ID bands, should not be touched.

What happens if the ID band is dipped?
Siemens’ internal studies show that the ID band can be dipped without errors or strip misidentification issues if proper technique is used. Follow the Dip It Right! instructions listed above.

Do I have to be retrained regarding dipping technique for the ID-banded strips?
No, the recommended dipping technique has not changed for ID-banded strips compared with strips that do not have the ID bands.
 

Frequently Asked Questions

- Questions about Auto-Checks?

What are Auto-Checks?
The Auto-Checks feature is Siemens’ latest innovation in urinalysis testing. It provides important automated quality checks with each sample tested. When using the newer CLINITEK Status family of analyzers along with validated Siemens urinalysis test strips, the Auto-Checks feature provides the following benefits for improved workflow, result integrity and clinical information:

  • Minimizes false-positive results with automatic notification if test strip has been degraded from humidity, preventing potentially erroneous patient results from being reported.*
  • Enables user compliance with IVDD regulations by reporting results only from urinalysis strips that have been validated for use on the CLINITEK Status analyzers.
  • Provides printed sample interference notes when common sample interferences are detected, providing healthcare professionals additional clinical information to aid in patient management.**
  • Eliminates the need to manually select strip type if using different urinalysis strips – saves time and reduces possible errors.

* Only available with Siemens test strips that have the leukocyte pad
**Feature not available in the U.S.

How can I obtain Auto-Checks for my urinalysis analyzers?
The Auto-Checks feature will be available when using validated Siemens urinalysis test strips on the CLINITEK Status+ analyzer, CLINITEK Status analyzers with version 2.0 software and higher and the CLINITEK Status Connect System. If you have CLINITEK Status analyzers with software version 1.9 or lower, you are able to upgrade the software to gain the Auto-Checks features. Contact your Siemens representative.

When are Auto-Checks available?
The Auto-Checks features will be available when using validated Siemens ID-banded strips on the CLINITEK Status+ analyzer, CLINITEK Status analyzers with version 2.0 software and higher and CLINITEK Status Connect System, as of July 11, 2011.

What Siemens urinalysis strips can be used on the CLINITEK Status family of analyzers to deliver Auto-Checks?
The following strips deliver Auto-Checks capabilities when used on the CLINITEK Status family of analyzers:

CLINITEK Microalbumin 2 MULTISTIX GP
CLINITEK Microalbumin 9 MULTISTIX PRO 10LS
Combistix SG N-MULTISTIX SG
Hemacombistix N-MULTISTIX SG L
Labstix SG N-Neostix
MULTISTIX 10 SG Uro-Hemacombistix SG L
MULTISTIX 8 SG Uro-Hemacombistix
MULTISTIX 7 Uristix
MULTISTIX 5 Uristix 4
MULTISTIX SG Uro-Uristix

Note: Auto-Checks features are only available with newer analyzers: CLINITEK Status+ analyzers, CLINITEK Status analyzers with software version 2.0 and higher, CLINITEK Status Connect System and CLINITEK Advantus analyzers version 3.0 and higher. Strip availability varies by country.
 

What changes can I expect after July 11, 2011?

If you are using CLINITEK Status+ analyzers, CLINITEK Status analyzers with software version 2.0 and higher, or CLINITEK Status Connect Systems with validated Siemens urinalysis strips you will not experience any changes.

However, if you are using non-validated urinalysis strips, the analyzer will generate an E50 error and results will not be reported.

If you are using non-validated urinalysis strips on earlier models of the CLINITEK Status family of analyzers, you will not experience any changes.

Can non-validated urinalysis strips be used with the CLINITEK Status family of analyzers?
Not after July 11, 2011. On that date, CLINITEK Status+ analyzers, CLINITEK Status analyzers with software version 2.0 and higher and CLINITEK Status Connect System will activate the automatic quality check to prevent errors that may occur when non-validated urinalysis strips are used on the above analyzers, since their performance on these analyzers cannot be guaranteed.

Why am I getting E50 Error code on the analyzer?
The following are common causes for E50 errors. Please check for the following:
a) Ensure that the urinalysis strip has been properly placed onto the analyzer test table and that it is not tilted.
b) Check that a programmed and validated Siemens urinalysis strip (identified below) is being tested. The analyzer will only report results from these urinalysis strips:

CLINITEK Microalbumin 2 MULTISTIX GP
CLINITEK Microalbumin 9 MULTISTIX PRO 10LS
Combistix SG N-MULTISTIX SG
Hemacombistix N-MULTISTIX SG L
Labstix SG N-Neostix
MULTISTIX 10 SG Uro-Hemacombistix SG L
MULTISTIX 8 SG Uro-Hemacombistix
MULTISTIX 7 Uristix
MULTISTIX 5 Uristix 4
MULTISTIX SG Uro-Uristix


 

c) Check that operators are using the proper dipping technique for the CLINITEK Status analyzer, as stated in the Instructions for Use.
d) Check that proper controls are being used. For a list of controls that have been shown to give optimal performance with the Siemens tests strips listed above, visit www.siemens.com/auto-checks.
e) Ensure that Siemens urinalysis strips used have the new identification (ID) band.

If I don’t want the Auto-Checks feature, do I have any options after July 11, 2011?
If you don’t want the Auto-Checks feature on your CLINITEK Status analyzer, you may contact your Siemens representative to discuss other available options.

Can non-Siemens strips be used on the older models: CLINITEK 50 and CLINITEK Status with software version lower than 2.0?
These analyzers do not have the Auto-Checks feature and may give results from non-Siemens urinalysis strips.

How will the July 11, 2011 change impact the older models: CLINITEK 50 and CLINITEK Status with software version lower than 2.0?
There will be no impact to these analyzers, since they do not have the new Auto-Checks software capabilities, and validated Siemens urinalysis test strips with the ID bands can be read on these analyzer.

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