Protected: QCMD – Molecular External Quality Control (NEW)

Home - QC - Page 4

Protected: QCMD – Molecular External Quality Control (NEW)

This content is password protected. To view it please enter your password below:


Product Spotlight: Respiratory Controls – Molecular Infectious Disease Testing

Randox Quality Contol Logo

Product Spotlight

Molecular Controls for Respiratory Infection Testing

Respiratory Infections

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].

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.

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 [3]. 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 [4].

Learn more about Flu Season
Qnostics - Molecular Controls for Infectious Disease Testing

The Qnostics range of complete molecular controls for infectious disease testing can be used in the daily monitoring of assay performance, linearity assessment, assay evaluation, validation/verification of new assays and staff training. As whole pathogen controls, the range is designed to mimic the performance of patient samples and can be used to effectively monitor the entire testing process including extraction, amplification and detection.

Qnostics offers a range of solutions for molecular respiratory testing:

Q Controls

Independently manufactured, these positive and externally run controls are designed to be treated as a patient sample within an assay run. Helping to support a laboratory’s accreditation requirements in line with ISO 15189:2012, Q Controls are supplied in an unassayed, liquid frozen format delivering accurate and reliable test results.

Analytical Q Panels

Each Analytical Q Panel consists of five or more individual samples including a negative and is designed to cover the dynamic range of individual infectious disease assays, in a linear progression. Analytical Q Panels are intended for use in the validation and verification of new assays with the main purpose of helping to ensure assays are linear throughout the dynamic range. In addition, Analytical Q Panels will support a laboratory’s accreditation requirements, in line with ISO 15189:2012.

Evaluation Panels

Evaluation Panels may be used to evaluate assay characteristics, confirm performance claims and ultimately ensure the assay is fit for purpose. Evaluation Panels may also be used in the validation of clinical assays and the development of diagnostic tests.

Learn more about Qnostics Respiratory Testing
Continue Reading

Flu Season

Molecular Respiratory Testing

Contact Us

Product Spotlight Home

Visit the Product spotlight Home to see past product spotlights

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

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


Infection: Making Sure You Get the Right Treatment

When you have an infection, it’s important to receive the correct diagnosis in order to access appropriate treatments. Misdiagnosis can not only lead to the prolonging of the infection, but could also prove detrimental to your long-term health, such as if you become resistant to certain anti-biotic strains through mistaken prescription.

Throughout this month, we’ve been highlighting how the Randox clinical product range can assess the impact of infection. The RX series’ dedicated testing panel comprises of IgA, hsCRP and ASO which are also available for third-party use. The extensive QC range caters for assessment of infectious disease testing in both liquid and lyophilised formats.

Reagents

The Randox range of third-party reagents enables the clinical analysis of 113 different analytes with comprehensive range measurements and excellent correlations to reference methods.

IgG (the most abundant antibody) and IgM (the first antibody made in response to infection) can be used in the diagnosis of Dengue Fever. This is significant as more than 40 % of the global population, in more than 100 countries, are at risk of the Dengue Virus.

IgA is an antibody that lines the mucous membranes lining the mouth, airways and digestive tract. A deficiency in IgA is common in patients with bronchitis, conjunctivitis and otitis media.

Other Randox assays that may be used to detect differing infections include: albuminferritinalpha-1-antitrypsin (AAT)complement C3complement C4haptoglobinCRP, alpha-1-acid glycoprotein (AGP) and anti-streptolysin (ASO).

RX series

The RX series range offers the most comprehensive testing profile for assessing infectious diseases within an individual. The RX series test menu possesses the most extensive infectious disease testing panel available to give an expansive picture of an individual’s health. The RX series zinc test will assess the levels of zinc in an individual, Zinc plays a significant role in an individual’s health s it’s functions include cell and enzyme production as well as wound healing.

To view the full RX series test menu click here.

Internal Quality Control

Randox has partnered with Qnostics to provide a wide range of molecular controls for infectious disease testing. Designed to meet the demand of today’s molecular diagnostics laboratory and laboratories carrying out Nucleic Acid Testing (NAT), the Qnostics Molecular Infectious Disease range comprises hundreds of characterised viral, bacterial and fungal targets covering a wide range of Transplant Associated Diseases, Respiratory Infections, Blood Borne Viruses, Sexually Transmitted Infections, Gastrointestinal Diseases and Central Nervous System Diseases.

External Quality Control

Randox have also partnered up with QCMD to offer a vast array of molecular EQA programmes for infectious disease testing. With an extensive database of over 2000 participants in over 100 countries, QCMD is one of the largest providers of molecular EQA in the field of molecular diagnostics.

Frequent challenges, comprehensive reports and international accreditation ensures the best assessment of test system performance.

For more information on how Randox is helping to diagnose infection accurately and effectively, visit www.randox.com.

 

 

 


Product Spotlight: Acusera Cardiac Quality Control

Product spotlight - Cardiac Quality Control Solutions
Cardiac Quality Control Solutions

For this month’s product spotlight, we have chosen our whole range of cardiac quality control solutions. Randox offers options for both Internal Quality Control (IQC) and External Quality Assessment (EQA).

29th September is World Heart Day. World Heart Day is a global campaign during which individuals, families, communities and governments around the world participate in activities to take charge of their heart health and that of others.

Cardiovascular disease (CVD) is a term to describe conditions that affect the heart and blood vessels. It is normally associated with a build up of fatty deposits in the arteries and an increased risk of blood clots. CVD is the leading casues of death globally, representing around 30% of all deaths. A healthy lifestyle can help prevent CVD; however, increasingly busy lifestyles mean that it is difficult to avoid CVD. This means it is vitally important that individuals are tested for CVD and to ensure that diagnoses are acurate.

Acusera Internal Quality Controls

The accurate diagnosis of a potentially life threatening cardiac event is essential in order to avoid misdiagnosis and/or incorrect treatment. The Acusera Cardiac Quality Controls have been designed to cover a wide range of cardiac markers at clinical decision levels eliminating the need for additional low level controls at extra expense. Available in a choice of both liquid ready-to-use and lyophilised formats, they are ideal for use at the point-of-care and in the laboratory. Manufactured from 100% human serum a matrix similar to that of the patient is guaranteed.

  • Liquid Controls

    Control Vial

    Liquid Cardiac Control

    Liquid, Assayed, 100% Human serum
    8 Analytes

    Control Vial

    BNP Control

    Liquid, Assayed, 100% Human serum
    1 Analyte

  • Lyophilised Controls

    Control Vial

    Cardiac Control

    Lyophilised, Assayed, 100% Human serum
    7 Analytes

    CK-MB Control

    Lyophilised, Assayed, 100% Human serum
    2 Analytes

    Control Vial

    H-FABP Control

    Lyophilised, Assayed, 100% Human serum
    1 Analyte

    hsTnT Control

    Lyophilised, Assayed, 100% Human serum
    1 Analyte

RIQAS External Quality Assessment

The RIQAS Cardiac EQA programme is designed to monitor the performance of up to 7 clinically significant cardiac markers. Two flexible reporting options are available to suit the needs of all laboratory sizes.

Accredited to ISO/IEC 17043

•  Lyophilised for enhanced stability
•  100% human serum
•  Bi-weekly reporting
•  Submit results and view reports online via RIQAS.Net
•  Register up to five instruments at no extra cost

Parameters

CK, Total | CK-MB activity units | CK-MB mass units | Homocysteine | Myoglobin | Troponin I | Troponin T

Continue Reading

Cardiac Controls

Cardiac EQA

Contact Us

Product Spotlight Home

Visit the Product spotlight Home to see past product spotlights


September focus: Infection

Throughout the month of September, we will be highlighting on our social media channels how the Randox clinical range can help combat infections and infectious diseases through accurate and swift diagnosis, allowing the necessary steps to be taken in order to improve individual health.

What is infection?

Infection is the infiltration of an organism’s body tissues by disease-causing agents, their multiplication, and the reaction of host tissues to the infectious agents and toxins they produce. Infectious disease can also be known as communicable disease and transmissible disease.

How is the Randox helping to diagnose infection?

The Randox portfolio comprises of a wide range of products to combat infections including the RX series’ dedicated infectious disease testing panel, diagnostic reagents such as copper, potassium and sTfR and an extensive QC range catering for infectious disease testing in both liquid and lyophilised formats.

How can I limit my risk of contracting infection?

  • The most important way to reduce the spread of infection is to wash your hands regularly with soap and water
  • If you have an infection, get the appropriate vaccine and do not take antibiotics when they are not needed. This will only increase antibiotic-resistance
  • Stay at home if you are sick to limit the spread of infection
  • Use single-use tissues and dispose of them immediately after use
  • Do not share cups, glasses or cutlery
  • Do not touch your eyes, nose or mouth as viruses can transfer from your hands and in to the body

How can my workplace limit the spread of infection?

  • Have an infection control plan
  • Provide clean hand washing facilities
  • Offer alcohol-based hand sanitisers when regular facilities are not available
  • Provide boxes of single-use tissues and encourage their use
  • Remind staff not to share cups, glasses or cutlery
  • Remove newspapers and magazines from waiting areas
  • Encourage staff to regularly disinfect their workspaces
  • Make sure ventilation systems are working properly

For more information on how Randox is helping to diagnose infection, visit www.randox.com/infections.

 

 

 


Molecular QC and EQA for Infectious Disease Testing

Molecular EQA / QC for Infectious Disease Testing

Earlier this year, Randox entered into a strategic partnership, bringing on-board Qnostics Molecular Controls and QCMD Molecular EQA which comprises hundreds of controls and EQA programmes for molecular infectious disease testing.

Background

The Global Molecular Diagnostics market is estimated to be worth 6.54 billion USD. This market is classified into infectious diseases, oncology, genetic tests and blood screening. Infectious diseases account for the largest share of the global market.

According to the World Health Organisation (WHO), Infectious Diseases are caused by pathogenic microorganisms, such as bacteria, viruses, parasites or fungi. These diseases can be spread – directly or indirectly – from one person to another.

Qnostics - Molecular Controls

Designed to meet the demands of today’s molecular diagnostics laboratory and laboratories carrying out Nucleic Acid Testing (NAT), the Qnostics range comprises hundreds of characterised viral, bacterial and fungal targets covering a wide range of Transplant Associated Diseased, Respiratory Diseases, Blood Borne Viruses, Sexually Transmitted Infections, Gastro-Intestinal Diseases and Central Nervous System Diseases.

Qnostics products can be used in the daily monitoring of assay performance, linearity assessment, assay evaluation, validation/verification of new assays and staff training.

There are five main product areas for Qnostics:

  • Product Groups (click to expand)

    Q Controls
    Independently manufactured, this range of positive run, whole pathogen, third party controls are designed to monitor the daily performance of a wide of range molecular assays used in the detection of infectious diseases. These controls help in supporting a laboratory’s accreditation requirements, in line with ISO 15189:2012.

    Analytical Q Panels
    Designed to cover the dynamic range of an assay, Analytical Q Panels allow assessment of an assays linearity, LOD and LOQ. Each panel contains a minimum of five samples, including a negative that spans the dynamic range of the assay in a linear progression.

    Molecular Q Panels
    Consisting of three levels (high, medium and low), Molecular Q Panels are intended to evaluate an assays analytical measuring range.  Molecular Q Panels can also be used to support training of laboratory staff and in the development of molecular diagnostic assays.

    Evaluation Panels
    Evaluation Panels cover a range of genotypes and may be used to evaluate assay characteristics, confirm performance claims and ultimately ensure the assay is fit for purpose. Evaluation Panels may also be used in the validation of molecular assays and development of new molecular diagnostic assays.

    QCMD Past Panels
    Available for use in assay evaluation and staff training, EQA samples are available from past QCMD challenges.

    Custom Manufacture

    Qnostics are specialists in the custom manufacture of quality control materials for use in the detection of infectious diseases using molecular based methods. Qnostics will work with you to develop a bespoke solution designed specifically to meet the individual and unique requirements of your lab.

    • Choose from hundreds of molecular characterised targets
    • Targets can be custom made into numerous different formats
    • The whole pathogen format accurately mimics clinical samples
    • All materials can be provided in a “ready-to-use” or liquid frozen format

    Qnostics custom made Molecular Infectious Disease Controls are designed to fit all stages of your assays product life cycle from product development to launch.

QCMD – Molecular External Quality Control

QCMD is a world leading External Quality Assessment (EQA) / Proficiency Testing (PT) scheme, dedicated to improving the quality of molecular diagnostic assays used in the detection of infectious diseases.

With an extensive database of over 2000 participants in over 100 countries, QCMD is one of the largest providers of molecular EQA in the field of infectious disease testing.

EQA participants receive an individual report outlining their performance relative to their method and technology groups. A supplementary report may be commissioned – this includes any additional relevant information regarding the annual EQA distribution, as well as scientific expert commentary and feedback on the overall results within that distribution.

  • Features & Benefits (click to expand)

    Frequency

    A variety of programme options are available. Choose the number of challenges that best suit your laboratory’s requirements.

    Online EQA Management System

    ITEMS provides an online tool to easily manage all EQA activities from programme registration to submission of results and provision of EQA reports. Different levels of user access are available so data can be accessed by whoever needs it.

    High level of participation

    Over 2000 participants in more than 100 countries ensuring peer group numbers are maximised.

    Comprehensive reports

    Receive individual reports for each challenge and a final supplementary report at the end of the cycle visual assessment of performance.

    International accreditation

    Programmes are accredited to ISO 17043.

Continue Reading

Qnostics

Contact Us


Product Spotlight: Acusera Immunoassay Premium Plus Control

Product spotlight - immunoassay premium plus
Acusera Immunoassay Premium Plus Control

The Randox Acusera Immunoassay Premium Plus quality control covers an impressive 54 analytes with assayed instrument specific target values and ranges provided for up to 51 analytes. The unique combination of routine tumour markers, therapeutic drugs and Vitamin D allows laboratories to dramatically reduce the number of controls required while ultimately keeping costs to a minimum. Three levels of control are available with analytes present at clinically significant levels.

Features & Benefits

  • Lyophilised for enhanced stability
  • 100% human serum
  • Assayed, instrument specific target values provided for up to 51 parameters
  • Ferritin and Vitamin B12 levels suitable for anaemia monitoring
  • Ultra low TSH levels in the level 1 control
  • Stable to expiry date at 2°C – 8°C
  • Reconstituted stability of 7 days at 2°C – 8°C or 4 weeks at -20°C
  • Contains routinely run tumour markers: AFP/CA15-3/CA19-9/CA-125/CEA/PSA/Free-PSA

Flexible options are available with a low, normal and high level, as well as a combined tri-level.

Description
Size
Analytes
Cat No.
Immunoassay Premium Plus Level 1 12 x 5 ml 54 IA3109
Immunoassay Premium Plus Level 2 12 x 5 ml 54 IA3110
Immunoassay Premium Plus Level 3 12 x 5 ml 54 IA3111
Immunoassay Premium Plus Tri-Level 4 x 3 x 5 ml 54 IA3112
Clinical Significance

The clinical significance of some selected analytes.

  • Androstenedione

    Androstenedione is an androgen, which are hormones responsible for the induction of sexual differentiation and produce secondary male physical characteristics such as a deep voice and facial hair. Another example is testosterone. They are also present in females as precursors to female hormones (such as estrogen).

    This test measures the amount of androstenedione in the blood. Because AD has its origins in the adrenal glands, it is useful as a marker of adrenal gland function, of the function of the ovaries or testicles, and androgen production.

    An androstenedione level may be used to [1]:

    Evaluate adrenal gland function and distinguish between androgen-secreting conditions that are caused by the adrenal glands from those that originate in the ovaries or testicles, if results of DHEAS and testosterone testing are abnormal
    Help diagnose tumours in the outer layer (cortex) of the adrenal gland or tumours outside of the adrenal gland that secrete ACTH (ectopic) and separate these conditions from ovarian or testicular tumours and cancers
    Diagnose congenital adrenal hyperplasia (CAH) and monitor CAH treatment, in addition to tests for testosterone and 17-hydroxyprogesterone
    Help diagnose polycystic ovarian syndrome (PCOS) and help rule out other causes of infertility, no monthly menstrual periods (amenorrhea), and excess body and facial hair (hirsutism) in women who have abnormal results on tests for DHEAS, testosterone, and other hormones such as FSH, LH, prolactin, and estrogen
    Help determine the cause of delayed puberty and investigate suspected ovarian or testicular failure
    Investigate and diagnose the cause of male physical characteristics (virilisation) in young girls and early (precocious) puberty in young boys
  • Digoxin

    Digoxin is a therapeutic drug used to treat abnormal heart rhythms and failure. Heart failure causes the heart to become less effective at circulating blood, resulting in blood backing up in the hands, legs, liver, and lungs, causing swelling.

    This test measures the level of digoxin in the blood. Digoxin is prescribed to patients to alleviate symptoms of heart failure by strengthening contractions, helping the heart pump blood more effectively. Digoxin can also be used to treat arrhythmias. It cannot be used to cure heart failure or arrhythmias but can help to manage the symptoms along with other medication, exercise and diet.

    Digoxin levels are monitored due to the drug’s narrow safety range. If the level is too high, toxicity may occur, if too low, symptoms may recur.

    A Digoxin level may be used to [2][3]:

    Monitor the concentration of the drug in the patient's blood
    Determine if a patient's symptoms are due to insufficient levels of Digoxin or due to digoxin toxicity
    Increase the strength and efficiency of heart contractions, helping control the rate and rhythm of the heart
    Slows electrical conduction between the atria and the ventricles, which is useful in treating abnormally rapid atrial rhythms that can cause heart attacks
  • Luteinizing Hormone (LH)

    Luteinizing Hormone (LH) is associated with the reproductive cycle and the release of an egg from the ovary in women and testosterone production in men. LH production is a complex system controlled by the hypothalamus in the brain, hormones produced in the testes and ovaries, and the pituitary gland.

    This test measures the amount of luteinizing hormone in the blood or urine. It is used alongside other tests such as FSH, estradiol, progesterone, and testosterone to investigate reproductive irregularities.

    A luteinizing hormone level may be used [4]:

    In both men and women:

    In the workup of infertility
    To aid in the diagnosis of pituitary disorders that can affect LH production
    To help diagnose conditions associated with dysfunction of the ovaries or testicles

    In women:

    In the investigation of menstrual irregularities
    To detect a surge in LH levels during the menstrual cycle, helping determine when a woman is likely to be the most fertile

    In children:

    To diagnose delayed and precocious (early) puberty. Irregular timing of puberty may be an indication of a more serious problem involving the hypothalamus, the pituitary gland, the ovaries or testicles, or other systems
  • Insulin

    Insulin is a hormone produced and stored in the beta cells of the pancreas. It is secreted as a response to an elevated glucose level following a meal and is vital in the transportation and storage of glucose, the body’s primary source of energy. Insulin regulates blood glucose by helping transport it from blood to cells.

    This test measures the amount of insulin in the blood. After a meal, carbohydrates are broken down into glucose, this is then absorbed into the blood causing the blood glucose level to rise, this then falls as it moves into cells. If an individual cannot produce enough insulin, or if they are insulin resistant (cells are resistant to insulin’s effects), glucose does not reach the body’s cells and they starve. The blood glucose level will rise to an unhealthy level, which can cause various complications, including Diabetes.

    An insulin level may be used to [5]:

    Diagnose an insulinoma, verify that removal of the tumor has been successful, and/or to monitor for recurrence
    Diagnose the cause of hypoglycemia in an individual with signs and symptoms
    Identify insulin resistance
    Monitor the amount of insulin produced by the beta cells in the pancreas (endogenous); in this case, a C-peptide test may also be done. Insulin and C-peptide are produced by the body at the same rate as part of the conversion of proinsulin to insulin in the pancreas
    Determine when a type 2 diabetic might need to start taking insulin to supplement oral medications
    Determine and monitor the success of an islet cell transplant intended to restore the ability to make insulin, by measuring the insulin-producing capacity of the transplant

    What test results mean [5]:

    Disorder
    Fasting Insulin Level
    Fasting Glucose Level
    Insulin resistance High Normal or somewhat elevated
    Not enough insulin produced in beta cells (diabetes, pancreatitis) Low High
    Hypoglycemia due to excess insulin (insulinomas, cushing syndrome) Normal or High Low
Continue Reading

Immunoassay Controls

Immunoassay EQA

Contact Us

  • References

    [1] “Androstenedione”, Labtestsonline.org, 2017. [Online]. Available: https://labtestsonline.org/tests/androstenedione. [Accessed: 07- Aug- 2018].

    [2] “Digoxin”, Labtestsonline.org, 2017. [Online]. Available: https://labtestsonline.org/tests/digoxin. [Accessed: 08- Aug- 2018].

    [3] O. Ogbru and J. Marks, “digoxin, Lanoxin: Drug Facts, Side Effects and Dosing”, MedicineNet. [Online]. Available: https://www.medicinenet.com/digoxin/article.htm#which_drugs_or_supplements_interact_with_digoxin?. [Accessed: 08- Aug- 2018].

    [4] “Luteinizing Hormone (LH)”, Labtestsonline.org, 2017. [Online]. Available: https://labtestsonline.org/tests/luteinizing-hormone-lh. [Accessed: 08- Aug- 2018].

    [5] “Insulin”, Labtestsonline.org, 2017. [Online]. Available: https://labtestsonline.org/tests/insulin. [Accessed: 08- Aug- 2018].

Product Spotlight Home

Visit the Product spotlight Home to see past product spotlights


Point of Care Testing (POCT) Explained

Point of Care Testing (POCT) Explained

Point of Care Testing (POCT) is the delivery of a test at the point in time at which the result will be used to make a decision and taking appropriate action resulting in an improved health outcome. It is also known as near patient, bed-side, extra-laboratory, decentralised, and ancillary testing [1]. It has been shown to reduce hospital stay time, reduce complications, and improve adherence to treatment [2].

Point of care testing is not a recent practice; many early diagnostic tests were administered at the bedside. However, analytical technology has progressed and multiple tests can be performed within minutes in a laboratory. Recently, this technology has been put into the hands of the staff near the patients [2]. There are two types of technology, benchtop analysers and hand held devices. Bench top systems are just smaller versions of laboratory analysers but some steps are automated. Hand held devices are simple in appearance but complex internally, they can manage several tasks including, adding reagents, separating cells from plasma, and reading colour or other measures.

BENEFITS OF POINT OF CARE TESTING

Results can be obtained faster, allowing for more immediate decisions meaning treatment can begin sooner. Patients can live a longer and higher quality life, helped by a reduction in the length of hospital stays.

Some benefits of POCT [2]:

•    Reduced number of clinic visits
•    Earlier discharge from hospital
•    Fewer unnecessary hospital admissions
•    Optimised drug treatment
•    More appropriate use of drugs
•    Reduced use of blood products
•    Reduced use of staff, equipment and space

Key objective

The main objective of Point of Care Testing is to generate results more quickly so that appropriate treatment can be provided, resulting in an improved patient outcome.

EFFECTIVE POINT OF CARE TESTING

Management

Accurate and reliable results can only be obtained if the patient and sample are treated correctly. Point of care testing is likely to be performed by staff with a limited technical background, so training and quality control are vital.

Outcomes

Proper analysis technique alone is not enough to ensure an accurate decision; any test will only be beneficial if the appropriate action is taken based on the result. The effectiveness of POCT is assessed in terms of the overall outcome of the patient.

WHERE DOES IT GO WRONG?

There are three phases in the POCT cycle: pre-analytical phase, analytical phase, and post-analytical phase. About 90% of quality issues are attributed to the pre-analytical and post-analytical phases [3]. These errors are mainly attributed to user error and can be caused by a number of issues including, selecting the wrong POCT device, not following manufacturer instructions, inadequate training, not adhering to appropriate QC practices, and many more.

The errors can usually be mitigated by implementing an action plan and ensuring it is executed exactly as designed, deviation from the action plan will lead to errors. Errors in POCT diagnostics can lead to misdiagnosis, improper treatment, costly follow-up procedures, and death.

Some strategies for improvement:

•    Ensure the POCT analyser is suitable for the kind of testing being undertaken
•    Ensure adequate QC to ensure your device is accurate and reliable
•    Develop a comprehensive training programme
•    Periodically carry out audits of POCT practices
THE NEED FOR QUALITY CONTROL

Internal Quality Control and External Quality Assessment is conducted to monitor the stability of the analytical measurement system and to alert the operator to a change that may lead to a medically significant error [6].

A study by Price, Smith and Bruel [8] was conducted on a number of labs over a period of time of up to 15 years. They discovered that test result performance improved with time and was associated with regular participation in External Quality Assessment (EQA) schemes and with the use of internal quality control (IQC) procedures.

Internal Quality Control

Internal Quality Control (IQC) is used to assess the day-to-day consistency of assay performance, providing quality assurance for patient results. IQC activities are among the ten most common POCT deficiencies. These may include performing and documenting quality control testing and taking the correct action for outliers [4]. This poor performance could be attributed to how IQC is viewed in POCT; users may lack appreciation of the potential for errors and may see the analyser as infallible, they likely see IQC as an additional workload as opposed to part of their testing routine.

CLSI regulations require risk assessment for each stage of patient testing alongside an implementation of a quality control plan. Below are some suggestions for how IQC should be conducted for POCT.

Conduct

IQC should be conducted when: a new lot of consumable is used; a patient result is queried; after maintenance; the device has been physically insulted. IQC should be conducted by the usual device operator so assurance can be provided for the whole testing process.

Training

ISO 22870 requires POCT users should be trained in the theory and practice of IQC [5]. Staff should be trained in every aspect of POCT including storage, preparation, frequency, documentation and basic troubleshooting.

Material

QC material for POCT should be obtained from a third party provider and not rely on material provided by the device manufacturer, the benefits of which are well documented. It should also contain analytes at clinically relevant concentrations, be provided ready-to-use, and be stable at ambient temperatures.

Results

All IQC results must be recorded with the date, time, user, decision to accept or reject, and any actions taken as appropriate. Locally assigned ranges alongside analyte-specific rules should be used to maximise error detection. An example of how IQC could be recorded and an action flowchart can be seen in Fig. A below.

Troubleshooting

There should be a protocol for required actions following a failed IQC. Any troubleshooting should be developed with knowledge of the most common errors and user capability.

Review

A monthly review should be conducted to identify persistent failures and trends.

The cost of IQC may also be a factor in resistance to IQC, however, while it is difficult to quantify, the cost of not conducting it may be greater in terms of human harm. A whitepaper is available detailing IQC in POCT (download).

Fig. A Examples of a manual IQC documentation, adapted from the Australian Government’s POCT General Practice [4]

Fig. A Examples of a manual IQC documentation, adapted from the Australian Government’s POCT General Practice  [4]. (Click to expand)

External Quality Assessment

External Quality Assessment (EQA) or Proficiency Testing (PT) involves running blind patient-like samples and comparing your results to peer results, in order to retrospectively monitor the accuracy of reporting. EQA samples should be treated as if they were a patient sample and therefore must be run by personnel who would normally use the device. This provides confidence in the reliability of patient test results. (Learn more about EQA)

Benefits of participation in an EQA programme include assessment of result accuracy, assessment over time, comparisons with instruments, methods and peers, and providing confidence in test results.

EQA for POCT is, in theory, similar to EQA in a large laboratory. There is a significant difference however, the POCT participants are usually health care professionals with little knowledge of laboratory medicine. A lack of understanding of the importance of EQA had led to a smaller percentage of sites participating than large laboratories.

A Good EQA Scheme

A good EQA scheme should offer:

•      Enables a comparison of performance between laboratories
•      Frequent reporting and rapid report turnaround time to minimise the amount of time an error can go unnoticed
•      High quality material in a format that works for you
•      Well-designed reports that allow for quick and easy troubleshooting of erroneous results at a glance
•      A sample matrix similar to a real patient sample
•      Large participant numbers to provide a large peer group to compare results to
•      A realistic range of analyte concentrations
•      Your entire range of tests in consolidated programmes, saving you time and money

“EQA should, as far as possible, cover the entire range of tests, and the entire examination process, from sample reception, preparation and analysis to interpretation and reporting.” [9]

ISO 15189

Conducting EQA in POCT

Below are some suggestions for how EQA should be conducted for POCT.

Conduct

EQA should be conducted by the operator who normally conducts patient testing to ensure the true workflow is assessed [6].

Material

EQA samples should be commutable, meaning they have the same numeric relationship between measurements procedures as is observed for a panel of patient samples (reacts the same as a real patient sample).

Report Frequency

Challenges / surveys should be frequent enough to identify systematic errors in a timely manner, affecting the fewest patient results [10].

Report Turnaround

A fast turnaround time allows test system errors to be identified sooner and necessary corrective actions to be taken immediately with minimum disruption to the lab.

Review

A regular review of past EQA results should be part of the cycle of quality.

Guidance

A POCT EQA provider should be able to provide assistance when the user is having difficulties.

Results

Individuals carrying out testing should have the correct knowledge to interpret results, choosing a scheme with easy to interpret results can help.

RANDOX POCT QUALITY CONTROL SOLUTIONS

Internal Quality Control

Randox offer a number of controls suitable for Point of Care Testing applications:

  • Acusera Blood Gas Control

    The Randox Acusera Blood Gas Quality Controls contain assayed target values for ten parameters, covering pH, pCO2, pO2, electrolytes, glucose and lactate. The material is provided in easy to open ampoules for added convenience and ease-of-use. The liquid ready-to-use nature of the control makes it ideal for use in point-of-care testing and on a wide range of blood gas instruments.

  • Acusera Liquid Cardiac Control

    The Randox Acusera Liquid Cardiac control is designed to be both convenient and easy to use. The liquid ready-to-use format makes it ideal for both clinical laboratories and point-of-care testing. Assayed, instrument specific values are provided for an impressive 8 cardiac markers including, NT-ProBNP, D-dimer and Troponin ensuring consolidation and flexibility. Furthermore, an open vial stability of 30 days for all analytes helps to keep waste and costs to a minimum.

  • Acusera Liquid HbA1c 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.

  • Liquid Urine Control

    The Randox Acusera Liquid Urine quality control is designed to be both convenient and easy to use. The liquid ready-to-use format eliminates issues with pipetting and allows convenient storage at 2℃ – 8℃. Assayed instrument and method specific target values and ranges are provided for 18 commonly tested urine chemistry parameters.

External Quality Assessment

Randox offers RIQAS Point of Care, a simple EQA scheme designed for use in point of care settings. It is a single sample, single scheme programme featuring whole blood samples for authentic patient sample assessment.

Learn More
Continue Reading

RIQAS

RIQAS Point of Care

Acusera

References

[1] C. Price, A. St john and J. Hicks, “Point-of-care testing”, 2004. [Online]. Available: http://mldt.hu/upload/labor/document/PRICEP.pdf. [Accessed: 23- Jul- 2018].

[2] C. Price, “Point of care testing”, BMJ, vol. 322, pp. 1285-1288, 2001.

[3] A. Okorodudu, “Optimizing accuracy and precision for point-of-care tests”, Acutecaretesting.org, 2011. [Online]. Available: https://acutecaretesting.org/en/articles/optimizing-accuracy-and-precision-for-point-of-care-tests. [Accessed: 24- Jul- 2018].

[4] H. Holt and D. Freedman, “Internal quality control in point-of-care testing: where’s the evidence?”, Annals of Clinical Biochemistry, vol. 53, no. 2, pp. 233-239, 2016.

[5] “ISO 22870:2016 – Point-of-care testing (POCT) — Requirements for quality and competence”, Iso.org, 2018. [Online]. Available: https://www.iso.org/standard/71119.html. [Accessed: 25- Jul- 2018].

[6] J. Gill and M. Shephard, “The Conduct of Quality Control and Quality Assurance Testing for PoCT Outside the Laboratory”, Clin Biochem Rev., vol. 31, no. 3, pp. 85-88, 2010.

[7] A. Stavelin and S. Sandberg, “Essential aspects of external quality assurance for point-of-care testing”, Biochemia Medica, pp. 81-85, 2017.

[8] C. Price, I. Smith and A. Van den Bruel, “Improving the quality of point-of-care testing”, Family Practice, vol. 35, no. 4, pp. 358-364, 2017.

[9] “ISO 15189:2012 – Medical laboratories — Requirements for quality and competence”, Iso.org, 2018. [Online]. Available: https://www.iso.org/standard/56115.html. [Accessed: 31- Jul- 2018].

[10] J. Crilly, “Mythbusting: Frequency of EQA Reports”, Randox Laboratories, 2017.

[11] G. Kristensen and P. Meijer, “Interpretation of EQA results and EQA-based trouble shooting”, Biochemia Medica, pp. 49-62, 2017.


Nutritional status: copper deficiency

Did you know that copper is an essential trace mineral present in all tissues? It works with iron to help the body form red blood cells. It also helps keep the blood vessels, nerves, immune system and bones healthy while also aiding in iron absorption. In rare situations, copper deficiency can occur and lead to anaemia and osteoporosis.

Symptoms of copper deficiency include:

  • Fatigue & weakness as cells use copper to generate ATP, the body’s main source of energy. This means that copper deficiency could affect your energy levels.
  • Frequent sickness as copper plays an important role in maintaining a healthy immune system.
  • Weak and brittle bones as copper is involved in the processes that create cross-links inside your bones. These cross-links ensure bones are healthy and strong.
  • Problems with memory and learning as copper plays an important role in brain function and development.

Sensitivity to cold as copper, along with minerals like zinc, help maintain optimal thyroid gland function. Low thyroid levels can make you feel colder more easily.

There are many foods that are high in copper. These include leafy greens, including turnip, greens, spinach, kale and mustard greens. Asparagus and summer squash are two other excellent sources of copper while legumes, whole grains, nuts and seeds are also good sources of the substance.

Randox Reagents, RX and QC are helping to diagnose copper deficiency at the earliest possible stage. The Randox copper assay is used to measure the levels of copper in the blood in order to determine copper toxicity. Combining this with the Randox zinc assay can aid in identifying the cause of liver damage in a patient, leading to correct treatment and recovery.

Find out more about how Randox is helping to diagnose nutritional status and deficiencies here: https://www.randox.com/nutritional-status/

 

 

 

 


Importance of External Quality Assessment (EQA)

The Importance of External Quality Control

External Quality Assessment (EQA) / Proficiency Testing (PT) allows for a comparison of a laboratory’s testing procedures to other laboratories across the world. Comparisons can be made to a peer group of laboratories or to a reference laboratory.

EQA involves running blind patient-like samples, comparing your results to peer results, in order to retrospectively monitor the accuracy of reporting. EQA samples should be treated as if they were a patient sample and therefore must be run by personnel who would normally use the device. This provides confidence in the reliability of patient test results.

“EQA is defined as a system for objectively checking the laboratory’s performance using an external agency or facility.”
World Health Organisation (2009)
Benefits of EQA

Participating in an EQA scheme allows a laboratory to gather valuable data, this data can be used in a variety of ways [1]:

 

  • Enables a comparison of performance between laboratories.

     

  • Enables a comparison of performance between testing sites.
  • Provides an early warning for systematic errors.
  • Indicates areas for improvement.
  • Provides evidence of quality.
  • Identifies training areas.
  • Detects equipment faults, identify reagent problems and review staff training.
  • Compares performance to different analytical methods.

EQA provides assurance to both staff and customers that testing taking place at your laboratory provides accurate and reliable results. Problems can be identified early on and corrective action can be untaken. The reliability of methods, materials, and equipment can be evaluated and training can be developed and its impact monitored.

Large laboratory groups can compare their performance with sites across their group, ensuring accuracy and consistency no matter where testing takes place.

EQA participation is often a requirement for accreditation, gaining accreditation alone has a host of benefits, not least an increased confidence in results from customers, current and potential.

“Quality Control materials shall be periodically examined with a frequency that is based on the stability of the procedure and the risk of harm to the patient from an erroneous result” [2]
ISO 15189
Benefits of EQA in Point Of Care Testing (POCT)

Point of care testing (POCT) refers to testing that is performed near or at the site of a patient with the result leading to a possible change in the care of the patient. The popularity and demand for POCT has recently seen rapid growth, this comes from the advantages including the added convenience of being able to obtain a rapid result at the patient’s bedside, thus allowing immediate action, saving time and improving the potential outcome for the patient.

Although there are many benefits of using POCT devices in terms of their convenience, these benefits are only true if the results produced are both accurate and reliable. Ensuring accuracy and reliability is the primary responsibility of Quality Control.

EQA is strongly recommended for all point of care devices and is recommended by ISO 22870, which providesspecific requirements applicable to point-of-care testing and is intended to be used in conjunction with ISO 15189.

“There shall be participation in external quality assessment schemes” [3]
ISO 22870
WHAT MAKES A GOOD EQA SCHEME?

There are many External Quality Control schemes that come in different varieties. EQA schemes can be mandatory, required either by accreditation or law. Others are voluntary and carried out by laboratories who want to ensure that they are carrying out accurate testing and improve the quality of the lab’s performance [1].

A good EQA scheme should offer:

  • Enables a comparison of performance between laboratories.
  • Frequent reporting and rapid report turnaround time to minimise the amount of time an error can go unnoticed.
  • High quality material in a format that works for you.
  • Well-designed reports that allow for quick and easy troubleshooting of erroneous results at a glance.
  • A sample matrix similar to a real patient sample.
  • Large participant numbers to provide a large peer group to compare results to.
  • A realistic range of analyte concentrations.

     

  • Your entire range of tests in consolidated programmes, saving you time and money.
“EQA should, as far as possible, cover the entire range of tests, and the entire examination process, from sample reception, preparation and analysis to interpretation and reporting.” [2]
ISO 15189
LIMITATIONS OF EQA

EQA is a great tool for comparing against a peer group and maintaining an effective QC strategy, however, it has its limitations.

EQA / PT alone cannot provide a complete evaluation alone; it is important to also run third party controls regularly. You can find out about the importance of third party controls here.

EQA results can also be affected by variables not relating to patient samples, including preparation, clerical functions, matrix effects, and selection of method. The errors can appear to be a downside to EQA but it can be used as a way to evaluate staff performance as well as assay performance.

PARTICIPATING IN EQA

If possible, every laboratory should participate in an EQA scheme that covers all testing procedures. Laboratories need to develop a management process with the objective to assure that EQA samples are treated appropriately and in the same manner. This includes, sample handling, sample analysis, record keeping, investigating deficiencies, taking corrective actions, and communicating results with laboratory staff and management.

SOURCES OF ERROR

Problems at any stage of sample analysis can cause errors, when an error does happen, all elements of the process need to be checked. Some examples of errors:

Pre Analysis

•  Incorrect sample handling during preparation, shipping or storage

•  Improper storage

•  The material has expired

•  An error in manufacturing

Analysis

•  Instrument, calibration or reagent defects

•  Staff competency

•  Matrix effects

•  Incorrect analysis method

Post Analysis

•  Report misinterpretation

•  Clerical or transcription errors

•  Failure to take corrective action

QUICK SUMMARY
•  EQA is a system for objectively checking a laboratory’s performance using an external agency or facility [1].
•  Where possible, all laboratories should participate in an EQA scheme for all tests that they perform.
•  EQA samples should be treated in the same way as a patient sample, using the same procedures, instruments, methods, and staff who normally perform the testing.
• EQA provides valuable resources and data to effectively maintain accurate and reliable results and should be seen as educational.
RANDOX INTERNATIONAL QUALITY ASSESSMENT SCHEME (RIQAS)

Randox offers RIQAS, the largest EQA scheme in the world with over 45,000 participants across 133 countries, offering 33 consolidated programmes. Randox also offers a range of over 90 molecular programmes for infectious disease testing with Quality Control for Molecular Diseases (QCMD).

Features and Benefits

null
null

Fully accredited to ISO/IEC 17043:2010

Outlines the general requirements for proficiency testing and demonstrates our commitment to quality.

 

null
null

Consolidated programmes

Over 360 parameters in 33 comprehensive programmes, RIQAS streamlines EQA by reducing the number of programmes required.
null
null

High frequency reporting

More frequent reporting allows for early detection of errors and allows corrective action to be taken much sooner, reports are retuned within 24-72 hours of the submission deadline.

 

null
null

The highest quality material

All RIQAS programmes use the highest quality raw materials, this ensures that concentrations are clinically relevant and the sample performs like a real patient sample.
null
null

User-friendly reports

RIQAS reports are presented in a simple one page per parameter format, facilitating performance assessment at a glance.

To learn more about RIQAS, visit the RIQAS homepage.

Continue Reading

RIQAS

RIQAS Point of Care

References

[1] WHO, Overview of External Quality Assessment (EQA). World Health Organisation, 2009.

[2] ISO 15189:2012 Medical laboratories — Requirements for quality and competence, 3rd ed. ISO, 2014.

[3] ISO 22870:2016 Point-of-care testing (POCT) — Requirements for quality and competence, 2nd ed. ISO, 2016.


Request a meeting
×
Make an Enquiry - RX series
×
Make an Enquiry - Reagents
×
Kit Insert Request - Reagents
  • Signing up to our mailing list is quick and easy. We do not wish to send you any spam or junk email, therefore, you can expect to receive mailshots including new product launches and updates, market trends, attendance at key industry events and much more. Randox Laboratories promise never to sell your data and we will keep all your details, safe and secure. Read more in our Privacy Policy.
×
Kit Insert Request - Reagents
  • Signing up to our mailing list is quick and easy. We do not wish to send you any spam or junk email, therefore, you can expect to receive mailshots including new product launches and updates, market trends, attendance at key industry events and much more. Randox Laboratories promise never to sell your data and we will keep all your details, safe and secure. Read more in our Privacy Policy.
×
Make an Enquiry - Reagents
×
Make an Enquiry - Quality Control
×
Make an Enquiry - RIQAS
×
Make an Enquiry - RIQAS
×
Make an Enquiry - Quality Control
×
Make an Enquiry
  • Signing up to our mailing list is quick and easy. We do not wish to send you any spam or junk email, therefore, you can expect to receive mailshots including new product launches and updates, market trends, attendance at key industry events and much more. Randox Laboratories promise never to sell your data and we will keep all your details, safe and secure. Read more in our Privacy Policy.
×
Make an Enquiry - Biochip
  • This field is for validation purposes and should be left unchanged.
×
Make an Enquiry - Molecular
  • Signing up to our mailing list is quick and easy. We do not wish to send you any spam or junk email, therefore, you can expect to receive mailshots including new product launches and updates, market trends, attendance at key industry events and much more. Randox Laboratories promise never to sell your data and we will keep all your details, safe and secure. Read more in our Privacy Policy.
  • This field is for validation purposes and should be left unchanged.
×
Make an Enquiry - Future Diagnostics
×
Make an Enquiry - RX series (Product)
×
Make an Enquiry - Quality Control