Interlaboratory Data Management – July 2019
Acusera 24•7 Live Online is an interlaboratory data management and peer group reporting package complementing the Acusera range of true third party quality controls. Designed to assist in the management of daily QC activities, Acusera 24•7 Live Online will help to meet regulatory requirements, improve error detection, reduce false rejections and ensure accurate patient results.
Delivering an online platform for effective QC data management, our software provides unique access to instantly updated real-time peer group data, automatically generated QC statistics, QC multi-rules, interactive charts and comprehensive reports.
‘The laboratory shall have a procedure to prevent the release of patient results in the event of quality control failure. When the quality control rules are violated and indicate that examination results are likely to contain significant errors the results shall be rejected… Quality Control data shall be reviewed at regular intervals to detect trends in examination performance’.
ISO 15189:2012
Why implement an interlaboratory program?
Acusera 24•7 Live Online is an essential QC tool for laboratories of all sizes. By participating and implementing our software your laboratory will be able to do the following;
- Quickly identify trends, system errors and reagent issues, minimising expensive repeat tests
- Automatically calculate Measurement Uncertainty, Total Error and Sigma Metrics
- Bridge the gap between daily quality control and external quality assessment
- Improve EQA performance by eliminating any undetected bias
- Facilitate regulatory compliance
- Minimise false rejections through the use of QC multi-rules
- Increase confidence in assigned QC target values
- Speed up troubleshooting processes, shortening delays in reporting
Acusera 24•7 key features and benefits
Peer group statistics are now uniquely updated live in real-time ensuring immediate access to the most up to date information available while ultimately reducing time and money spent troubleshooting, re-running samples and performing instrument maintenance. Peer groups may be based on worldwide statistics or an affiliate group of laboratories meaning you can instantly discover how you compare to other laboratories using the same lot of QC and identify if issues are unique to your laboratory or a widespread problem.
Available at no extra cost the unique dashboard allows instant identification of any QC failures and from the last seven days. Designed to significantly reduce the time spent analysing data, this highly convenient and user-friendly function means corrective action can be taken immediately with minimum disruption to the laboratory’s output. Alerts are also provided when a control lot is reaching expiry, reducing the risk of using expired material.
Levey-Jennings, Histogram and Performance Summary Charts are generated on demand, delivering quick and easy performance monitoring. With Acusera 24•7 Live Online, users have the ability to add multiple instruments, parameters and lots to a single chart allowing comparative performance assessment and immediate visualisation of any ongoing or emerging trends.
The user-friendly interface and interactive nature of the chart allows you to view data for a specific date range, zoom in on a specific data point, comment on individual data points and record events including calibration and reagent lot changes for enhanced review of trends.
Our software now automatically calculates %Bias, Total Error and Sigma metrics, enabling enhanced performance assessment and improved QC strategy design for your laboratory. The added benefit of Uncertainty of Measurement (UM) helps to meet ISO 15189 requirements. In addition results may be rejected or alerted based on QC multi-rules or user defined performance limits including Rilibak, CLIA and biological variation.
The Acusera Advisor tool will conveniently recommend a set of QC multi-rules and a minimum QC frequency for each assay based on previous performance history. Tailoring QC multi-rules to each assay in this way will make QC processes more efficient whilst ensuring high error detection rates.
Designed to help speed up the review process a range of comprehensive reports are available including, Statistical Metrics Reports, Uncertainty of Measurement Report, Exception Report, and the Audit Trail Report which provides a secure, electronic record of the creation, modification and deletion of data. This effective method of documenting the review process can help laboratories meet regulatory requirements and gain accreditation.
Evaluate and review any poor performing QC tests
The Data Review report displays data for all QC tests which have fallen outside your laboratory’s user-defined performance limits. Data may be filtered by date, instrument, lot number or rule violation. It may also be filtered to display only alerted/rejected results. The report can be exported or printed easily, to document the review process.
As always, results are colour-coded for added convenience. Once results have been evaluated, managers can record their actions by marking each result as ‘reviewed’. A ‘reviewed’ result will no longer appear on the Dashboard.
Our fully automated connectivity solution is designed to meet the needs of all laboratory types and sizes. QC data can be quickly and efficiently imported from LIMS to Acusera 24•7 Live Online without the need to import files or manually enter data.
- Reduce workload by eliminating issues associated with manual data entry
- Increases productivity and efficiency
- Captures and imports only QC data
- Secure real-time connection without disruption to the laboratory
- The software is also capable of bi-directional communication with LIMS
Acusera CO2 & Electrolytes Linearity Verifier
Dedicated Linearity Verifier for the measurement of CO2 and electrolytes on Roche Cobas analysers. This verifier is supplied in a liquid ready-to-use format and can be used to objectively verify calibration of the instrument. Five levels are available spanning the instrument’s complete reportable range.
Features & Benefits
- Convenient, liquid ready-to-use format
- 5 levels provided
- 7 day stability when stored at 2ºC to 8ºC
- Shelf life of up to 2 years from date of manufacture
| Description | Size | Analytes | Cat No | |
|---|---|---|---|---|
| Acusera CO2 and Electrolytes Linearity Verifier | 5 x 5mL | 4 | LV10362 | |
Analytes
- CO2
- Sodium
- Potassium
- Chloride
Acusera Therapeutic Drug Monitoring (TDM) Linearity Verifier
Our Therapeutic Drug Monitoring (TDM) Linearity Verifier comprises 16 commonly tested drugs in a single vial. Dedicated for use on Roche Cobas systems, and available in a liquid frozen format, this verifier is convenient and easy to use. Five levels span the instrument’s entire reportable range.
Features & Benefits
- Convenient, liquid frozen format
- 5 levels provided
- 14 day stability when stored at 2ºC to 8ºC
- Shelf life of up to 2 years from date of manufacture
| Description | Size | Analytes | Cat No | |
|---|---|---|---|---|
| Acusera Therapeutic Drug Monitoring Linearity Verifier | 5 x 5mL | 16 | LV10355 | |
Analytes
- Acetaminophen
- Amikacin
- Carbamazepine
- Digoxin
- Gentamicin
- Lithium
- N-Acetylprocainamide
- Phenobarbital
- Phenytoin
- Procainamide
- Quinidine
- Salicylate
- Theophylline
- Tobramycin
- Valproic Acid
- Vancomycin
Acusera Apolipoproteins Linearity Verifier
Dedicated Linearity Verifier for measuring Apo A-1 and Apo B on Roche Cobas analysers. Supplied in a liquid frozen format this linearity verifier will objectively verify calibration of the
instrument whilst remaining convenient and easy to use. Five levels are provided spanning the instrument’s reportable range.
Features & Benefits
- Convenient, liquid frozen format
- 5 levels provided
- 14 day stability when stored at 2ºC to 8ºC
- Shelf life of up to 2 years from date of manufacture
| Description | Size | Analytes | Cat No | |
|---|---|---|---|---|
| Acusera Apolipoproteins Linearity Verifier | 5 x 3mL | 2 | LV10363 | |
Analytes
- Apolipoprotein A-1 (Apo A-1)
- Apolipoprotein B (Apo B)
Acusera Lipids Linearity Verifier
Our Lipids Linearity Verifier comprises 4 common lipid assays and is specifically designed for use on Roche Cobas analysers. Five levels are available and span the instrument’s complete reportable range. Designed in a liquid frozen format, this linearity verifier will objectively verify calibration of the instrument whilst remaining convenient and easy to use.
Features & Benefits
- Convenient, liquid frozen format
- 5 levels provided
- 14 day stability when stored at 2ºC to 8ºC
- Shelf life of up to 2 years from date of manufacture
| Description | Size | Analytes | Cat No | |
|---|---|---|---|---|
| Acusera Lipids Linearity Verifier | 5 x 3mL | 3 | LV10364 | |
Analytes
- HDL Cholesterol
- LDL Cholesterol
- Total Cholesterol
- Triglycerides
Acusera RF Linearity Verifier
Dedicated Rheumatoid Factor (RF) Linearity Verifier supplied in a liquid ready-to-use format specifically for use on Roche Cobas analysers. Designed to objectively verify calibration
whilst remaining convenient and easy to use, there are five distinct levels provided that span the instrument’s complete reportable range.
Features & Benefits
- Convenient, liquid ready-to-use format
- 5 levels provided
- 14 day stability when stored at 2ºC to 8ºC
- Shelf life of up to 2 years from date of manufacture
| Description | Size | Analytes | Cat No | |
|---|---|---|---|---|
| Acusera RF Linearity Verifier | 5 x 1mL | 1 | LV10343 | |
Analytes
- Rheumatoid Factor (RF)
Acusera Esoterics Linearity Verifier
Our Esoterics Linearity Verifier comprises 6 analytes and is supplied in a liquid ready-to-use format specifically for use on Roche Cobas analysers. Designed to objectively verify calibration whilst remaining convenient and easy to use, there are five distinct levels provided that span the instrument’s complete reportable range.
Features & Benefits
- Convenient, liquid ready-to-use format
- 5 levels provided
- 14 day stability when stored at 2ºC to 8ºC
- Shelf life of up to 2 years from date of manufacture
| Description | Size | Analytes | Cat No | |
|---|---|---|---|---|
| Acusera Esoterics Linearity Verifier | 5 x 3mL | 6 | LV10336 | |
Analytes
- Acetaminophen
- Ammonia
- Ethanol
- Microalbumin
- Urinary Protein
- Salicylate
Acusera hsCRP Linearity Verifier
Dedicated hsCRP Linearity Verifier supplied in a liquid ready-to-use format specifically for use on Roche Cobas analysers. Designed to objectively verify calibration whilst remaining convenient and easy to use, there are five distinct levels provided that span the instrument’s complete reportable range.
Features & Benefits
- Convenient, liquid ready-to-use format
- 5 levels provided
- 14 day stability when stored at 2ºC to 8ºC
- Shelf life of up to 2 years from date of manufacture
| Description | Size | Analytes | Cat No | |
|---|---|---|---|---|
| Acusera hsCRP Linearity Verifier | 5 x 1mL | 1 | LV10335 | |
Analytes
- High Sensitivity C-Reactive Protein (hsCRP)
Acusera CRP Linearity Verifier
This dedicated CRP Linearity Verifier is supplied a liquid ready to-use format, specifically for use on Roche Cobas analysers. This verifier is designed to objectively verify calibration whilst remaining convenient and easy to use. There are five distinct levels provided that span the instruments’ complete reportable range.
Features & Benefits
- Convenient, liquid ready-to-use format
- 5 levels provided
- 14 day stability when stored at 2ºC to 8ºC
- Shelf life of up to 2 years from date of manufacture
| Description | Size | Analytes | Cat No | |
|---|---|---|---|---|
| Acusera C-Reactive Protein (CRP) Linearity Verifier | 5 x 1mL | 1 | LV10334 | |
Analytes
- C-Reactive Protein (CRP)
Product Spotlight: HbA1c Quality Controls
Diabetes
Diabetes is a life-long condition which occurs when the glucose level in the blood is too high because it can’t enter the body’s cells to be used as fuel. There are two types of diabetes: type 1 and type 2. They are distinct conditions and must be treated and managed differently.
Type 1 Diabetes
Type one diabetes is an autoimmune condition in which the body attacks insulin-producing cells, this causes a lack of insulin, leading to an increased blood glucose level. Around 10% of people with diabetes has type 1.
Type 2 Diabetes
A mixture of genetic and environmental factors causes type 2 diabetes. The body doesn’t make enough insulin or the insulin it does create does not work correctly, leading to a glucose build up in the blood. It’s thought that up to 58% of type 2 diabetes can be prevented or delayed through healthy lifestyle choices.
HbA1c
HbA1c is the average blood glucose level for the past two to tthree months. A high HbA1c means there is too much sugar in the bloodstream. This means the patient is more likely to develop complications associated with diabetes, like problems with feet and eyes [1].
HbA1c in Diagnostics
In 2011, the WHO accepted the use of glycated haemoglobin (HbA1c) testing in the diagnosis of diabetes, Diabetes UK also supports this decsion [2].
Clinically Significant Levels
A HbA1c level of 6.5% is recomended as the cut off for diabetes diagnosis [3], this can be seen in Fig. 1.
Fig. 1. Clinically relevant levels for Diabetes diagnosis.
Acusera HbA1c Controls
Acusera HbA1c Quality Control
The Randox Acusera HbA1c control is designed for use in the quality control of both HbA1c and Total Haemoglobin assays. Assayed instrument and method specific target values and ranges are provided for all major systems and methods including HPLC. A reconstituted stability of 4 weeks keeps waste to a minimum and helps to reduce costs.
Acusera Liquid HbA1c Quality Control
Conveniently supplied liquid ready-to-use the Liquid HbA1c control is ideally suited to both clinical laboratories and POCT helping to significantly reduce preparation time. With a stability of 30 days waste and costs are also kept to a minimum.
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References
[1] “What is HbA1c?”, Diabetes UK, 2018. [Online] Availabel: https://www.diabetes.org.uk/guide-to-diabetes/managing-you-diabetes/hba1c.
[2] Diabetes UK, “Diagnostics criteria for deabetes”, Diabetes UK, 2018. [Online]. Available: https://www.diabetes.org.uk/professionals/position-statements-reports/diagnosis-ongoing-management-monitoring/new_diagnostic_criteria_for_diabetes.
[3] WHO, “Use of Glycated Haemoglobin (HbA1c) in the Diagnosis of Diabetes Mellitus”, World Health Organisation, 2011.