RIQAS Performance Assessment – Z Score vs SDI

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RIQAS Performance Assessment – Z Score vs SDI

Z Score vs SDI

Z Score vs SDI

You work hard to implement top class quality control in all areas of your laboratory. The success of your labours is reported to you through your External Quality Assessment (EQA) results. It can be frustrating when your report is returned, only for you to find that you’ve been assigned a poor performance score due to other laboratories in your participation group.

At RIQAS, we want your EQA results to reflect your performance, not that of everyone else, to truly illustrate the efficacy of your quality control procedures. This is why, instead of Z scores, we report your performance in terms of a Standard Deviation Index (SDI). However, we know that in some countries, you’re required to report a Z score. Don’t fret. You can still find this result in the .csv file provided with your report.

A Z score is a statistical measurement that describes a value’s relationship to the mean of a group of values. In other words, it’s a value calculated to tell us how many standard deviations (SDs) a result is from the expected mean. Z score is reported in terms of SD’s, therefore a Z score of 0 shows the result is identical to the mean.

While useful in many cases, when used in EQA, a Z score can give a false perception of performance. We want RIQAS participant performance assessment to be based on their individual performance, rather than being impacted by how well, or poorly, the other laboratories in the group performed for a sample.

Z score is calculated using a variable SD. This means that as results are added, the mean and SD can change. For example, if overall performance for a sample improves, the CV associated with the data will decrease, causing an increase in Z score. Let’s take a quick look at how RIQAS performance assessment works, and then we can get into SDI.

RIQAS Performance Assessment.

Our target scoring system has been developed to provide a simple interpretation of your laboratory’s performance. To calculate a target score, your result is calculated as a percentage deviation (V) from the Mean for Comparison. This deviation is then compared to a Target Deviation for Performance Assessment (TDPA) to calculate the Target Score.

The difference between your result and the mean for comparison is expressed as a Target Score (TS) using the following mathematical formulae:

Target Score

The better your percentage deviation compared to the TDPA, the higher your Target Score will be.

Performance Scores

TDPA are set to encourage participants to achieve and maintain acceptable performance. Target Deviations are assigned to be fit-for-purpose and take all possible sources of variation into account, including sample homogeneity and stability as per ISO/IEC17043, ISO13528 and IUPAC.

In general, the TDPA is set so that ~10% laboratories achieve Target Scores less than 50. However, depending on homogeneity and stability, the TDPAs may be adjusted, so that participants’ performance is not adversely affected by sample variability. If your % deviation (V) is equal to the Target Deviation for Performance Assessment (TDPA) then a target score of 50 is achieved.

RIQAS reviews TDPAs annually and the methods used to assign them have been agreed by the RIQAS Advisory Panel.

TDPA

Standard Deviation Index (SDI)

To provide a more accurate assessment of performance, we use SDI instead of Z score. SDI is a score which compares the participant’s difference from the assigned value (mean for comparison) with an evaluation interval called the Standard Deviation for Performance Assessment (SDPA).

The SDPA calculation involves a series of steps. First, we calculate a CV for Performance assessment (CVPA) as shown below:

CVPA

As mentioned, the TPDA is normally set so that ~10% of laboratories achieve a TS less than 50. In such cases, the t-value used to convert TDPA to CVPA is ~1.645. However, depending on homogeneity and stability, the TDPA may need be increased, so that participants’ performance is not adversely affected by sample variability. In such cases less than 10% of laboratories will have poor performance, and a larger t-value will be chosen to convert TDPA to CVPA

We then convert CVPA to SDPA:

SDPA

Using this equation, an initial SDPA is calculated for every mean for comparison (i.e. for all methods, method, and instrument statistics). However, for new parameters or those which have small participation numbers, it’s not always possible to assign a target deviation, TDPA or SDPA. In such cases, the SDPA will be the SD calculated when the mean for comparisons is generated.

According to ISO/IEC17043, when the assigned value is based on consensus (mean for comparison), the uncertainty of the assigned value must be calculated and combined with the SDPA when it is considered to be significant. This forms an adjusted SDPA, which is used to calculate the participant’s performance in terms of SDI.

Using the SDPAadjusted we can calculate SDI using the formula below:

SDI

On your RIQAS report, you’ll find the SDI associated with the current sample in the text section of each report page. We also provide your last 20 SDIs, plotted on a Levey-Jennings chart, along with an indication of the mean for comparison for each sample (I = Instrument group, M = Method group, or A = All Methods group). Acceptable performance is an SDI of less than ± 2.

SDI History

RIQAS EQA

RIQAS is the world’s largest EQA scheme with more than 75,000 laboratory participants spanning over 138 countries. Choosing an EQA provider is no easy task. That’s why we’ve produce a guide to help you find the right one for you. You can download it here.

At RIQAS, we’re always coming up with new ways to make your performance assessment and result interpretation even easier. We’re also proud of our new programmes and pilot schemes. This year, we’re running pilot programmes for Anti-psychotic drugs, Chagas and Blood Typing.

If you’d like to find out more about the range of programmes we provide, visit our website or download our brochure. Alternatively, you can get in touch with us at marketing@randox.com.


Randox Covid-19 Testing: Evaluating the health, social and economic impacts

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3rd April 2023: COVID-19 Report Reveals How Randox’s 25 Million PCR Tests Averted Thousands of Hospitalisations and Deaths And Delivered Billions of Pounds Of Economic Benefits

A new report on the work of leading diagnostics company Randox shows that its COVID-19 PCR testing in the public and private sectors averted more than 3,000 UK deaths and 14,100 additional hospitalisations during the pandemic emergency.

That assessment is contained in an evidence-based report into the performance and delivery of Randox during the crisis, compiled by internationally respected economic development consultants OCO Global.

As well as illustrating the impact of PCR testing on deaths and hospitalisations, the report provides an assessment of the wider economic benefit of the test and trace programme.

It reveals that Randox testing delivered £8.3 billion of benefits to the UK economy, by reducing transmission and expediting the return to work for key workers, as well as facilitating social engagement and international travel, crucial to economic recovery.

The report is believed to be one of the most comprehensive analyses of any company awarded government Covid-19 contracts.  It will also be provided to the COVID-19 Public Inquiry to assist their considerations regarding future evidence that may be required.

In total, the OCO Global report confirms that Randox processed over 17 million PCR tests as part of the government’s national testing programme between March 2020 and June 2022. The company also provided a further 7.7 million PCR tests plus around 1.8 million lateral flow tests to corporate clients and international travelers.

The report estimates that Randox’s private testing facilitated 4.4 million international return journeys, many of them crucial to support the economy in a time of medical and financial emergency. Other tests supported the nation’s social fabric, enabling people to travel for leisure purposes and to meet families.

The evidence highlights the Northern Ireland-based company’s 40 years experience as one of the world’s leading diagnostic testing companies. This experience, says the OCO report, coupled with the company’s ability and willingness as a private business to innovate and invest its own resources in rapidly upscaling to meet the crisis enabled it successfully to deliver testing on a vast scale. The report also says that innovation in software, automation and robotics, in particular, helped ensure that Randox optimised laboratory efficiency and drove down costs to the benefit of contracting parties.

The report sets out the high level of financial risk taken by Randox during the pandemic and their rapid expansion of laboratories, staff levels and capacity to meet the emergency demand for testing.

In just ten months, Randox increased its capacity to process PCR tests – from 300 tests per day on March 30th 2020, to 120,000 per day by January 2021.

This involved building, equipping and staffing 80,000 square feet of PCR testing laboratory space at the Randox Science Park in County Antrim – the equivalent of a football pitch of new laboratory space.

Overall, the report confirms these improvements and development enabled Randox to deliver 12 per cent of the UK’s PCR testing – and a considerably higher percentage at times when Covid-19 cases, hospitalisations and deaths rocketed to their highest levels. It also notes that the Randox rate of void samples was 15 per cent below the average for the testing programme as a whole.

The report adds: “These improvements would be passed on to the UK Treasury as Randox was able to drive down the cost of testing from £49.60 to £18.00.

“Private individuals also benefited from Randox process improvement as the company was at the forefront of driving down the price of private testing. By October 2021 the cost of a PCR test (click and collect) would be £34.99, a 70 percent decrease from December 2020.”  This price included the sample collection kits and all logistics and services, not within the government contracts.

In assessing Randox’s performance the report goes on to say:  “Randox is a privately owned company that can make decisions quickly and this proved invaluable in the frenetic early stages of the pandemic when companies and governments across the world were scrambling for supplies and consumables.

“Randox’s willingness to invest came with significant risk: through the majority of the National Testing Programme, Randox were only paid for tests completed and there were no guarantees that payment for the number of tests indicatively contracted for would be received.

“This placed considerable risk with Randox who were having to purchase vast quantities of consumables, despite the uncertainty around how long the pandemic would last or how government policy might change.

“It was this successful risk management which enabled Randox to be one of the best performing laboratories across the National Testing Programme.”

Gareth Hagan, CEO of OCO Global said:

“OCO Global was commissioned by Randox to compile a full, open and comprehensive report into the value of the company’s work, performance and delivery of PCR testing during the pandemic. Randox was a cooperative partner, providing access both to data and to personnel from across the organisation.

“We were able to use external interviews and data sources to corroborate our research. We are satisfied that the facts and the evidence-based findings of our report accurately reflect the work of Randox  during the Covid-19 emergency.”

A spokesman for Randox said:

“We believe this report delivers clear evidence of the performance, outcomes and value of the work which Randox is proud to have carried out during one of the greatest peacetime emergencies to have hit the world and the UK.

Editors Notes

Gareth Hagan is interview for media interview

OCO Global is a leading specialist provider of trade and investment services. Headquartered in Northern Ireland, OCO Global has offices in the UK, Ireland, Germany, France, Japan, UAE, China and the U.S.

OCO Global’s clients include leading national, state and regional economic development organizations such as The Department For International Trade (DIT), Enterprise Florida and The Japan External Trade Organization (JETRO), as well as private companies seeking to enter new markets or grow their domestic base, including EY, PWC, Siemens, Smiley Monroe, Pepsico and Santander.

Media Enquiries to Ian Monk /Heather Vernon

Ian.monk@woburnpartners.com                  +44 7970 026072

Heather.vernon@woburnpartners.com      +44 7747 097821

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Randox response to the Public Accounts Committee (PAC) report, ‘Government’s contracts with Randox Laboratories Ltd’

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27th July 2022: Randox response to the Public Accounts Committee (PAC) report, ‘Government’s contracts with Randox Laboratories Ltd’

A spokesperson for Randox said:

“The PAC report is deeply flawed and wrong in assumptions it makes and the conclusions it draws about Randox.

“As the UK’s largest diagnostic company, with four decades of experience, over 2,000 professional staff on hand at the start of the pandemic and more than £350m of prior investment in diagnostic and engineering innovation, Randox was uniquely situated to respond to the national need when COVID-19 emerged in early 2020.

“In supporting the UK’s urgent requirement for coronavirus testing Randox reacted with speed, efficiency and flexibility in delivering value. The company developed and built, in record time, the UK’s largest COVID-19 laboratories and testing services. It provided the Department of Health and Social Care with a PCR testing capacity at the time of greatest need, rising from 300 tests per day to 120,000 per day by January 2021.

“Altogether Randox processed over 25 million samples for UK’s National Testing Programme and in support of international travel for business and personal reasons. This played a crucial role in keeping vital elements of the UK economy functioning during lockdowns.

“In adapting to rapidly changing DHSC and Department of Transport requirements, Randox delivered unique value to the government, the national economy and to individuals.

“At no stage, either during its deliberations or in its preparation of this report, did the PAC make any contact whatsoever with Randox. Consequently many elements of its report relating to Randox are false, based as they are, on wrong and unchecked assumptions about the company. For that reason, they and any publications arising from them are the subject of a legal complaint.”

“The issues the report raises around internal DHSC record keeping are clearly a matter for DHSC”

For all media enquiries, please contact Ian Monk on ian@ianmonk.com or  +44 7970 026072 / + 44 203 011 1933

 

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COVID Contracts | Randox Statement

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11th November 2021: COVID Contracts | Randox Statement

Randox  states categorically that political lobbying played no role in the award of Covid contracts to the company. The Department of Health and Social Care (DHSC) contracts to provide Covid-19 testing were awarded on merit to Randox as the largest healthcare diagnostic company from the UK. The entire process was transparent and compliant with government regulations in a time of national crisis.

Randox has almost 40 years experience in testing and diagnostics: it was one of the first companies in the world to develop a Covid-19 test and to have developed extensive laboratory, IT and logistic infrastructure to support large scale testing operations. The decision to award Covid-19 contracts was fully validated by the company’s performance and delivery under the terms of the contracts.

The company was awarded its initial Covid contract on 30 Mar 20 and, within a short period, had exceeded the initial Covid-19 testing capability of the entire NHS.

Subsequent DHSC planning required Randox to deliver 17,000 tests per day by the end of April and more beyond then. To facilitate and ultimately enable these extraordinary levels of delivery, Randox was temporarily allocated 5 extraction systems from universities in order to increase capacity. DHSC directed the Army to collect equipment, in line with their support for all Pillar 2 laboratories.

This was a pragmatic and transparent move by the DHSC to meet a critical national need to save lives and ease overwhelming pressure on the NHS.  The extraction systems were returned once the systems ordered by Randox, against the backdrop of a global shortage of such equipment, had been delivered and installed.

Randox and its staff have striven tirelessly and innovatively to support the national Covid-19 testing effort. We are proud of our collective achievement at a time of crisis in being the only Pillar 2 laboratory to have reported in excess of 100,000 Covid-19 results in one day.

 

For all media enquiries, please contact Ian Monk on ian@ianmonk.com or  +44 7970 026072 / + 44 203 011 1933

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Randox strengthen partnership with Sheffield United by agreeing to become naming right partner of the widely-acclaimed Sheffield United Academy

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08th October 2021 – Randox strengthen partnership with Sheffield United by agreeing to become naming right partner of the widely-acclaimed Sheffield United Academy

Sheffield United have today announced a further strengthening of their principal partnership with Randox. The healthcare giants have agreed to become naming right partners of the widely-acclaimed Sheffield United Academy.

Located at Shirecliffe, it is the base of the men’s, women’s and academy teams. The facility, since its opening its doors in the early 2000s, has seen the likes of Kyle Walker, Harry Maguire, David Brooks, Dominic Calvert-Lewin and Aaron Ramsdale all progress through the academy ranks.

Established in 1982 in Northern Ireland, Randox is the largest healthcare diagnostics company from the UK and Ireland. In 2019 Randox manufactured over four billion tests and operated in over 145 countries. The company employs more than 2,500 staff, including more than 450 research scientists and engineers, with key facilities located in Co. Antrim and Co. Donegal.

Randox Managing Director Dr Peter FitzGerald CBE said: “We are very excited for the opportunity to extend our partnership by aligning Randox with the Sheffield United Academy. With almost 40 years of experience in the manufacture of world-leading medical diagnostics and comprehensive health check and sports science services, Randox is well positioned to assist in the development of the health, wellbeing and performance of these elite athletes. We look forward to working with the Academy and to lending our expertise to make further developments in cutting-edge sports science.”

United’s head of commercial, Paul Reeves, said: “This is a significant further investment from Randox and a long-term commitment to our next generation of players, both male and female. The academy plays an integral part within the club and it goes without question the rising importance of developing players of all ages to continue to compete on a global scale. We would like to thank Dr FitzGerald and his colleagues for their valued contribution.”

Paul added; “The newly-named Randox Health Academy has some exciting prospects on the horizon with the likes of Daniel Jebbison, Femi Seriki and Iliman Ndiaye all making their Premier League debuts at the end of the 20/21 season.”

Visit randoxhealth.com to find out more about their ground-breaking R&D, advanced health checks, and rapid COVID travel tests.

For press enquiries please contact Amy Millar in the Randox PR team on amy.millar@randox.com or 028 9442 2413

Want to know more?

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Randox supports Northern Ireland travellers to the Algarve with essential COVID-19 PCR ‘test-to-return’ service

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21st May 2021 – Randox supports Northern Ireland travellers to the Algarve with essential COVID-19 PCR ‘test-to-return’ service

The NI Executive has today announced that, from 24th May,  travellers from Portugal to Northern Ireland must arrive with a negative COVID-19 PCR test.  This varies from travellers to England, where a lateral flow test is also a possibility.  Randox, the UK’s largest COVID-19 PCR testing provider, have recently announced that travellers to the Algarve will be able to purchase a COVID-19 “test-to-return” kit. In a first for the industry, NI holidaymakers will then be able to have their self-collected samples promptly flown from their holiday destination to Randox’s laboratories in Antrim for gold standard PCR testing. Results are emailed to the traveller ready in time for their flight home.

In response to high demand from British holidaymakers to visit Portugal, Randox has partnered with the largest laboratory chain in the Algarve to offer holidaymakers to the region this new quick and easy solution. Travellers simply purchase and take their ‘test-to-return’ kit to Portugal and, at their convenience, self-collect their sample 3 days before the return flight.  Travellers drop their sample at one of the listed partner laboratory sites and samples are then flown to Randox’s testing facilities in Antrim.  Customers receive their results the next day.  The partner laboratory has many convenient sites across the Algarve, including at Lagos, Portimao, Lagoa, Silves, Albufera, Loule, Faro, Olaho and Quartiera.

The PCR test-to-return service will be available to travellers returning on flights from the Algarve from the 7th June and will cost £60 per testing kit. As a package travellers from NI can also purchase from Randox PCR tests for pre-departure from the UK and the required Day 2 test on return.

Sophie Boyd, Randox Operations Manager, said;

“As the UK gradually opens up to international travel, we are delighted to be able to offer those visiting the Algarve the ability to have a fast and reliable PCR ‘test-to-return’ service, which means travellers have one less thing to worry about and can concentrate on enjoying their holiday. This is particularly relevant for travellers from Northern Ireland. Through our partner network we also have support for the traveller in the Algarve, should they need it.

“Randox is now able to process 500,000 tests a day for international travel – more than any other laboratory in Europe – and to date our laboratories have processed over 13 million tests. We are working hard to support the international fight against the pandemic by offering testing services that allow people to live their lives as normally as possible.

Randox, with almost 40 years of international diagnostics experience, has been at the forefront of COVID-19 testing since the outset of the pandemic. With proven testing capability and well-established logistics and customer support services, Randox are strongly placed to support the return to international travel.

Randox, with almost 40 years of international diagnostics experience, has been at the forefront of COVID-19 testing since the outset of the pandemic. With proven testing capability and well-established logistics and customer support services, Randox are strongly placed to support the return to international travel.

For further information on our COVID testing services please contact the Randox COVID Customer Support team on covidcustomersupport@randox.com or 0800 2545 201.

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9th April 2021: 12 million tests on the National Testing Programme

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09TH APRIL 2021: THE 12 MILLION MILESTONE 

We are pleased to let you know that on 09th April 2021, Randox processed its 12 millionth sample within the UK COVID-19 National Testing Programme.

That’s an incredible 12 million samples processed by our dedicated and talented staff.

Our staff are our best asset and have risen to the challenge this pandemic has created.

They have worked hard and flexibly, been creative and innovative, and pulled together as a team to make an impact in the fight against COVID-19.

We are very proud of their efforts and teamwork.

Let us once again say thank you to each and every member of Team Randox, for the efforts they have made.

What we do at Randox remains vital to the national and global management of COVID-19 and our work is making a real and positive difference.

We continue to work hard and improve, for the sake of our family, friends and communities.

For further information please email randoxpr@randox.com

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The Six Million Tests Milestone: 2nd December 2020

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2ND DECEMBER: THE 6 MILLION MILESTONE 

We are pleased to let you know that on 2nd December, Randox surpassed 6 million tests within the UK COVID-19 National Testing Programme.

That’s an incredible 6 million samples accessioned, processed and tested by our dedicated and talented staff.

Our staff are our best asset and have risen to the challenge this pandemic has created.

They have worked hard and flexibly, been creative and innovative, and pulled together as a team to make an impact in the fight against COVID-19.

We are very proud of their efforts and teamwork.

Let us once again say thank you to each and every member of Team Randox, for the efforts they have made in 2020.

What we do at Randox remains vital to the national and global management of COVID-19 and our work is making a real and positive difference.

We continue to work hard and improve, for the sake of our family, friends and communities.

For further information please email randoxpr@randox.com

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Flu Season – Molecular Infectious Disease Testing

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Spotlight Home        IQC        EQA        Infectious Diseases

28 September 2018

Flu Season

Influenza (Flu)

Flu is a contagious respiratory illness cause by influenza viruses that infect the throat, nose, and sometimes lungs. It can cause illness and sometimes death. Getting vaccinated is the best way to prevent catching flu [1].

There are four types of seasonal flu, A, B, C, and D. Types A and B cause seasonal epidemics of disease. Illnesses range from severe to mild and can even result in death in high risk groups. High risk groups include, pregnant women, children under 5 years of age, the elderly, and people with chronic or immunosuppressive medical conditions [2].

Symptoms of Flu [3]

• Sudden fever (temperature above 38C)
• Feeling tired
• Headache
• Sore throat
• Loss of appetite
• Aching
• Chesty cough

Diagnosing Flu

A test to detect Influenza viruses can be used to determine whether a patient has the flu. A swab is taken from either the nose or back of the throat and sent for testing. Molecular assays can be used to detect genetic material of the virus [4]. Molecular methods play an important role in the diagnosis and surveillance of influenza viruses. Molecular diagnostics allow timely and accurate detection of influenza and are already implemented in many laboratories. The combination of automated purification of nucleic acids with real-time PCR should enable even more rapid identification of viral pathogens such as influenza viruses in clinical material [5].

The spread of Flu

Flu season begins as early as October, reaches its peak in February, and ends in March. In the southern hemisphere, flu season falls between June and September. Wherever it’s cold, it’s flu season. This can be seen in Figure A below, which shows google searches for the term ‘flu’ for the last five years for USA (northern hemisphere) and Australia (southern hemisphere). It is obvious that flu is prevalent at different times in the northern and southern hemisphere.

However, it’s a common misconception that flu is caused by the cold. There are many theories as to why the flu season comes in winter [7]:

1. People spend more time indoors, with windows closed, not getting fresh air.
2. A lack of Vitamin D and melatonin from reduced sunlight, weakening the immune system.
3. Influenza virus thrives in the cold, dry air of winter

Of course, there have been attempts to test these theories, but animals do not contract the virus like humans, so testing is difficult. A researcher named Peter Palese decided to test theory 3 after finding an old medical journal article that reported guinea pigs are infected and spread the flu like humans.

Google Searches for 'Flu' in USA and Australia for the last 5 years
Figure A. Google Searches for ‘Flu’ in USA and Australia for the last 5 years [6]

Having set up cages with varying temperatures and relative humidity, he observed how they affected the spread of the flu virus. He found Influenza spread more effectively in cold, dry air [8].

A theory about why this is the case is associated with how the virus moves through the air. When someone breaths out, they release little virus-containing droplets in to the air. The droplet then begins to evaporate. A lower relative humidity means there is less water in the air, meaning there is more room in the air for additional moisture, allowing the droplets to evaporate. A higher humidity means the droplet can’t evaporate because there isn’t as much room for more moisture, and the virus is not suspended into the air [9].

Whatever the case, the fact remains: when winter comes around, the flu will follow.

Prevention

You can avoid catching the flu by getting the flu shot, investing in a humidifier, keeping your hands clean, and limiting contact with those who are already ill. Immunity gained from vaccination decreases over time, so annual vaccination is recommended. Vaccines are most effective when they closely match viruses in circulation. The constantly evolving nature of Influenza viruses requires the WHO Global Surveillance and Response System to monitor influenza viruses around the world and update vaccinations accordingly.

Personal protective measures can be taken in addition to vaccination [2]:

• Properly washing and drying the hands
• Covering the mouth and nose when coughing and sneezing
• Self-isolation when showing symptoms of influenza
• Avoiding contact with sick people
• Avoiding touching the eyes, nose, and mouth

How Randox can Help

Randox offers molecular controls, calibrators, and EQA programmes for respiratory infection testing, which includes Influenza A and B, Adenovirus, Rhinovirus, and others.

Want to know more?

Contact us or visit our Qnostics page to learn more.

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  • References

    [1] “Key Facts About Influenza (Flu) | Seasonal Influenza (Flu) | CDC”, Cdc.gov, 2018. [Online]. Available: https://www.cdc.gov/flu/keyfacts.htm. [Accessed: 25- Sep- 2018].

    [2] “Influenza (Seasonal)”, World Health Organization, 2018. [Online]. Available: http://www.who.int/en/news-room/fact-sheets/detail/influenza-(seasonal). [Accessed: 27- Sep- 2018].

    [3] “Flu”, nhs.uk, 2018. [Online]. Available: https://www.nhs.uk/conditions/flu/. [Accessed: 25- Sep- 2018].

    [4] “Diagnosing Flu | Seasonal Influenza (Flu) | CDC”, Cdc.gov, 2018. [Online]. Available: https://www.cdc.gov/flu/about/qa/testing.htm. [Accessed: 25- Sep- 2018].

    [5] J. Ellis and M. Zambon, “Molecular diagnosis of influenza”, Reviews in Medical Virology, vol. 12, no. 6, pp. 375-389, 2002.

    [6] “Google Trends”, Google.com, 2018. [Online]. Available: https://trends.google.com/trends/. [Accessed: 26- Sep- 2018].

    [7] “The Reason for the Season: why flu strikes in winter – Science in the News”, Science in the News, 2014. [Online]. Available: http://sitn.hms.harvard.edu/flash/2014/the-reason-for-the-season-why-flu-strikes-in-winter/. [Accessed: 26- Sep- 2018].

    [8] A. Lowen, S. Mubareka, J. Steel and P. Palese, “Influenza Virus Transmission Is Dependent on Relative Humidity and Temperature”, PLoS Pathogens, vol. 3, no. 10, p. e151, 2007.

    [9] “Why Is There a Winter Flu Season?”, Popsci.com, 2013. [Online]. Available: https://www.popsci.com/science/article/2013-01/fyi-why-winter-flu-season#page-5. [Accessed: 26- Sep- 2018].


Reconstituting Lyophilised Controls

What is Lyophilisation?

Lyophilisation or ‘freeze drying’ is the process by which water is removed from a product after it is frozen and placed under a vacuum, allowing the ice to change directly from solid to vapor without passing through a liquid phase. The process consists of three separate processes:

  1. Freezing
  2. Primary Drying (Sublimation)
  3. Secondary Drying (Desorption)

There are many benefits to using a lyophilised control including; improved product shelf-life and enhanced stability of volatile analytes. For example, many lyophilised controls have a shelf life of up to four years from the date of manufacture resulting in a reduction of costly new lot validation studies. Furthermore, lyophilised controls can be aliquoted and refrozen to extend the working stability of the product.

Reconstituting Lyophilised QC Material

The process of reconstitution involves adding a specified volume of distilled water to lyophilised QC material. The water should completely dissolve the lyophilised contents, giving a liquid solution, which is ready for analysis.

Reconstitution is a straightforward process, but requires a high level of precision. Small errors can have serious implications to the reconstituted material:

  • If too much water is pipetted during reconstitution, the material will be heavily diluted and results will be lower than expected
  • If too little water is pipetted during reconstitution, the material will not be sufficiently diluted, and results will be higher than expected
  • If the correct volume of water is pipetted, but a small amount of water gets stuck in the pipette tip due to poor pipetting technique, results will be higher than expected

If a lyophilised control has been reconstituted incorrectly the contents of the vial will be wasted. It is therefore vitally important that controls are reconstituted with care.

Materials and Methods Required

The list of requirements for an accurate and consistent reconstitution technique is not extensive, but each requirement is vital. Labs should have:

  • Calibrated volumetric pipettes
  • Sterile, appropriately sized pipette tips
  • Distilled water, or other reconstitution fluid as specified
  • Technician with good pipetting technique
  • Lyophilised QC stored according to manufacturer’s specifications

How to Reconstitute Lyophilised QC Material

Each different lyophilised control may require slightly different preparation, always refer to the instructions for use before reconstituting control material. The below guide provides a general overview of the reconstitution process, using the Randox Human Assayed Chemistry Premium Plus control (HN1530) as an example

  1. Place the vial of lyophilised QC on a flat surface, carefully remove the lid and the rubber stopper making sure not to spill any material
  2. Using a calibrated pipette and sterilised pipette tip, add exactly 5ml of distilled water directly into the QC vial, ensuring no water is left in the pipette tip, or on the rim/side of the vial
  3. Place the rubber stopper and lid firmly back onto the QC vial, and leave to stand for 30 minutes
  4. After 30 minutes, gently invert the QC vial 10-15 times to ensure the contents is completely dissolved, making sure to avoid the formation of foam. It is important that you DO NOT SHAKE the vial. Alternatively place the vial on a roller for 30 minutes to ensure the contents is thoroughly mixed
  5. Once satisfied all material has been completely dissolved, proceed to use the QC product in accordance with the ‘Control’ section of the individual analyser application
  6. Once finished, refrigerate any unused material. It is good practice to label the vial with the date of reconstitution to prevent the use of material outside of the recommended stability period
  7. Prior to reusing lyophilised material, mix the contents thoroughly by gentle inversion, as highlighted in Step 4

Additional Considerations

It is important to remember that there may be slightly different reconstitution requirements for different QC material. For this reason, it is vital that the instructions provided on the QC Kit Inserts are closely followed.

Reconstituting lyophilised QC can be time-consuming. Therefore, Randox Acusera offer convenient 5ml distilled water serum diluent to assist laboratories with reconstitution of lyophilised controls. These user-friendly pour over vials streamline the reconstitution process and eliminate the risk of pipetting errors.

If you have any further questions regarding lyophilised controls or would like to contact us, please do so by emailing us at acusera@randox.com or use the contact us button provided.


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