Urine/CSF Albumin Reagent. Urine/CSF Albumin Calibrator

Transcription

1 December 2014 PRODUCT ANNOUNCEMENT AU Clinical Chemistry Systems AU400/400 e, AU480, AU640/640 e, AU680, AU2700, AU5400, and AU5800 Product Urine/CSF Albumin Reagent Urine/CSF Albumin Reagent Urine/CSF Albumin Calibrator Kit REF B38858 B46435 B38859 Dear Beckman Coulter AU Customer: Beckman Coulter, Inc. is pleased to announce the release of a new Urine/CSF Albumin reagent in addition to a new Urine/CSF Albumin calibrator for use on the Beckman Coulter AU clinical chemistry analyzers. The new Beckman Coulter Urine/CSF Albumin reagent and calibrator will replace the current Microalbumin reagent, REF OSR6x67, and calibrator, REF ODR3024. The reason for this transition is to harmonize reagents between Beckman Coulter AU and Synchron platforms plus the added features of extended upper analytical range and increased prozone tolerance. As recommended by the National Kidney Disease Education Program - International Federation of Clinical Chemistry (IFCC) Working Group on the standardization of albumin in urine, the name of the assay will now change from Microalbumin to Urine/CSF Albumin in order to reflect current practice. The new Urine/CSF Albumin reagent is a turbidimetric method for the quantitative determination of albumin concentration in human urine and cerebrospinal fluid (CSF). The new reagent kit consists of a 2-component Urine/CSF Albumin reagent and is available in 2 kit sizes. The tests per vial for each kit size on each AU analyser are outlined below. New Reagent REF Package Configuration Analyser Tests/ Vial Test/Kit Urine/CSF Albumin B38858 R1: 4x32.6 ml R2: 4x4.4 ml AU400/400 e /480/640/ 640 e / AU2700/5400/ B58824-AA

2 New Reagent REF Package Configuration Analyser Tests/ Vial Test/Kit Urine/CSF Albumin B46435 R1: 4x54.8 ml R2: 4x7.3 ml AU400/400 e /480/640/ 640 e / AU2700/5400/ A new multi-level ready to use liquid calibrator is also available; New Calibrator REF Package Configuration Urine/CSF Albumin Calibrator Level 1, 2, 3, 4, 5 B38859 Levels 1-5: 2 ml Features of the new Urine/CSF Albumin assay include: 2-part ready to use liquid reagent for human Urine and CSF Albumin 60 day reagent on-board stability 60 day calibration stability Analytical range: Urine mg/l, CSF mg/l On-board dilution for samples exceeding the analytical range (1 in 10 dilution with deionized water or 0.9% saline, using automatic dilution function) Limit of Quantitation (LOQ): Urine 7 mg/l ( 0.7 mg/dl), CSF 10 mg/l ( 1.0 mg/dl) Prozone tolerance up to 20,000 mg/l using Data Check Parameters Reagent probe Contamination Avoidance Parameters have been developed for use with the new reagent. New sample probe Contamination Avoidance Parameters have also been developed for use when changing from Serum to Urine samples on the AU2700, AU5400, AU5800, AU480 and AU680. Recommended quality control materials for the new AU Urine/CSF Albumin assay include the Bio-Rad Liquichek Microalbumin and Spinal Fluid controls. The following marketed lots contain value assignment for the new AU Urine/CSF Albumin assay. The target values and ranges are available on the Bio-Rad website; Control REF Lots Bio-Rad Liquichek Microalbumin Controls Level 1 and Level 2 Bio-Rad Liquichek Spinal Fluid Controls Level 1 and Level 2 378, , , 96670, 96680, 96690, , 55590, 55600, 55610, The Urine and CSF Method Comparison data for Urine/CSF Albumin reagent B46435/B38858 versus Microalbumin reagent OSR6x67 on an AU5800 analyzer is attached. The new Urine/CSF Albumin assay recovers higher than the current Microalbumin assay due to the difference in B58824-AA Page 2 of 5

3 calibrator traceability. The new assay is traceable to IFCC standard CRM 470 while the current assay is traceable to a purified Albumin Standard quantified using a theoretical extinction coefficient. The Urine and CSF Method comparison data for the Beckman Coulter Urine/CSF Albumin reagent B46435/B38858 versus an Albumin test on a Siemens BN ProSpec Nephelometer is also attached. For both Urine and CSF, the new Urine/CSF Albumin reagent on the AU5800 correlates extremely well with the Siemens nephelometry method. The Urine/CSF Albumin Instructions for Use (BLB38858) will be available in multiple languages on the Technical Documents page of the Beckman Coulter website through the following link: Instrument Settings/ Parameters (BSB38858), Calibrator Value Assignment Sheets, and (Material) Safety Data Sheets (M)SDSs as well as Contamination Avoidance Parameters will also be available at the above link. Please share this information with your laboratory staff and retain this notification as part of your laboratory documentation. If you have any questions, please contact Beckman Coulter Technical Support at from the United States and Canada or from Europe or your local Beckman Coulter Representative. Thank you for your continued support of Beckman Coulter products and services. Sincerely, Kerri Breasley Senior Marketing Manager Chemistry Systems Enclosures: Method Comparison graphs for OSR6167 versus B46435/B38858 on AU5800 for CSF and Urine Method Comparison graphs for B46435/B38858 on AU5800 versus an Albumin test on a Siemens BN ProSpec Nephelometer for CSF and Urine 2014 Beckman Coulter, Inc. All rights reserved. Beckman Coulter, the Beckman Coulter logo, and AU are trademarks of Beckman Coulter, Inc. and are registered in the USPTO. Bio-Rad and Liquichek are trademarks of Bio-Rad Laboratories Ltd. Siemens and ProSpec are trademarks of Siemens. All other trademarks are the property of their respective owners. B58824-AA Page 3 of 5

4 Method Comparison of B46435/B38858 versus OSR6167 on an AU5800 analyser A. Urine samples B. CSF samples n: 117 Slope: Intercept: mg/l r: n: 49 Slope: Intercept: mg/l r: Figure 1. Method comparison graphs for OSR6167 vs. B46435 using A. Urine samples and B. CSF samples including Deming regression summary details. B58824-AA Page 4 of 5

5 Method Comparison of B46435/B38858 on an AU5800 versus an Albumin Urine/CSF test on a Siemens BN ProSpec Nephelometer A. Urine samples B. CSF samples n:121 Slope: Intercept: mg/l r: n: 51 Slope: Intercept: mg/L r: Figure 2. Method comparison graphs for B46435 vs. an Albumin Urine/CSF test on a Siemens BN ProSpec Nephelometer method using A. Urine samples and B. CSF samples including Deming regression summary details. B58824-AA Page 5 of 5