1. Virology Department, Queen Elizabeth Hospital, Woolwich. Claire Warren, David Westrip

2.  Recently incorporated into the Lewisham and Greenwich NHS Trust  Supports a population of 260,000  Processing approximately 100,000 virology tests per annum on the Woolwich site  Generally staffed with 2-3 BMS and 2-3 MLA’s on a five day week, 9-5:30 basis.  Department operates as a routine diagnostic laboratory offering a comprehensive virology/serology service to the hospital, local GP’s and outpatient clinics

3. Bench-top analyzerBench-top analyzer Touch screenTouch screen Random access and STATRandom access and STAT Throughput: 60 tests/hourThroughput: 60 tests/hour Time to first result: ~30 minutesTime to first result: ~30 minutes Up to 20 dedicated reagent packs refrigerated on- boardUp to 20 dedicated reagent packs refrigerated on- board Tests available 24/7Tests available 24/7 Up to 30 samples on-board at any one timeUp to 30 samples on-board at any one time Assays in use – CMV IgG and IgM, Rubella IgG, HBsAg, HB core, anti HBs AND HCV. 3 BIO-FLASH Instrument Features

4.  The assays evaluated in this study on the BIO-FLASH had also been previously performed using automated ELISA based methods.  This requires samples requiring specific assays to be batched up and where necessary separated into different racks.  This often resulted in several different aliquots of the same specimen being present in different racks to ensure all required testing was performed  As a result some testing was not being performed from the primary tube and it was often difficult to locate samples

5. RunFrequency (approx) AntenatalDaily HIV, Syphilis, HBsAgDaily HCV, HB coreTwice Weekly Anti HB sWeekly CMV IgM, IgGWeekly Additional assays to be run weekly included VZV EBV Parvovirus This placed significant time pressure on the analysers

6. Sample received Primary clots run on BIO-FLASH Follow up work carried out as necessary Samples then separated for serum save and any further testing as required

7. 7 Sample processing and validation – BEST2000 Validation and reflex testing Report generation – 4 sheets of paper Emptying the system Processing Loading reagents – all individual reagents are loaded onto the BEST2000 at the start of every run Loading of samples onto BEST2000, barcodes scanned and interface assigns tests Collect Samples and reagents from the fridge 183 mins 178 mins 177 mins 170 mins 36 mins 16 mins 2 mins Senior BMS BMS Analys er BMS

8. 8 Validation and reflex testing – reflex tests can be added on and put back on the BIO-FLASH immediately if required. Report generation Emptying the system – samples only. Reagents are stable on board Processing Loading reagents, daily maintenance and loading QC Download work list off the interface and load samples Collect Samples and reagents from the fridge. © Werfen. All rights reserved. Confidential. For internal use only. 134 mins 129 mins 128 mins 127 mins 7 mins 00 mins 2mins Senior BMS BMS Analyser BMS

9.  TOTAL pre analytical time for ELISA on the BEST2000 – 62mins  TOTAL Time by ELISA on the BEST2000 – 183mins  Lab Staff time – 50mins  Analyser time – 130mins  TOTAL pre analytical time for BIO-FLASH – 32mins  TOTAL Processing Time with BIO-FLASH- 134mins  Lab Staff time – 14mins  Analyser time – 120mins to process 90 samples Includes BIO-FLASH constant Loading – 30mins* *Loading will be continuous but samples only

10.  Reduces the need to aliquot samples saving time and consumables.  Eliminates batching – decreases turn around times.  On board reagents results in less wastage and cleaner audit trails.  Tests which were previously run infrequently such as HCV and HB anti S, are now performed routinely within 24 hours of receipt

11.  Adoption of the BIO-FLASH as a primary analyser has resulted in significant improvements in both workflow and turnaround times  This removed pressure from existing analysers such as the Best 2000 and DS2 systems freeing up capacity for other testing to be performed more frequently.  Simplicity of operation has allowed samples to be run through the night and over weekends when necessary.