Seafood is one of the most important exports in India with its shrimp being a staple food in many countries worldwide. However, 2017 and 2018 saw 27 shipments of shrimp refused entry into the US by the FDA. This was followed closely in January 2019, when 26 lines were refused due to the presence of two banned antibiotics, nitrofurans and chloramphenicol.
With Indian shrimp accounting for around one third of the countries seafood exports, India has expressed its concern over the rejections. It responded by calling the tests on the products ‘too stringent’.
The global shrimp industry is estimated to be worth around $30 billion and India’s market share is estimated at 13% in value terms.
Dr. Ramraj, President of the All Indian Shrimp Hatcheries Association has stated, “some of the metabolites in shrimp and crustacean shells are known to mimic antibiotics and therefore could give false results”.
The use of antibiotics in shrimp farming in India is banned. Madhusudano Rao, Principal scientist at India’s Central Institute of Fisheries Technology has said, “All shrimp hatchery operators and shrimp farmers and advised to use only these antibiotic- free inputs during shrimp farming”.
Randox Food Diagnostics offer the most comprehensive range of ELISA and Biochip tests currently on the market, specifically designed to identify and detect the smallest traces of the most prevalent antibiotics used in seafood, including nitrofurans and chloramphenicol.
The Evidence Investigator is a compact, semi-automated benchtop analyser which is renowned for its versatility, robustness and effective reporting methods. The Evidence Investigator has offered efficient and comprehensive testing in a wide range of laboratory settings for many years including, clinical diagnostics, molecular, research, toxicology and food diagnostics.
The Evidence Investigator is the perfect fit for medium throughput laboratories seeking maximum use of bench space and can process up to 44 results from a single sample, with a maximum throughput of up to 2376 tests per hour.
It is extremely well equipped to provide reliable and accurate results because results are generated using Charge Coupled Device (CCD) camera, which quantifies chemiluminescent light. The light then measures the degree of binding between the sample and specific biochip bound ligands. The Evidence Investigator image processing software translates light signal generated from chemiluminescent reactions into analyte concentrations which removes the need for any manual processing of data.
Our molecular product range offers diagnostic, prognostic and predictive solutions across a variety of disease areas including sexually transmitted infection (STI), respiratory tract infection, colorectal cancer, familial hypercholesterolemia (FH) and cardiovascular disease (CVD). Additionally, we can provide a wide range of assay formats including single nucleotide polymorphisms (SNP) genotyping, pathogen detection and mutation detection. The technology allows simultaneous detection of multiple analytes from a single sample for efficient and cost-effective testing.
STI and Respiratory Arrays
Sexually transmitted infections (STIs) affect more than 1 million people every day and each year 500 million new cases of STIs occur.1 Therefore, it is vital for early and accurate detection. Randox’s Sexually Transmitted Infections Multiplex Array simultaneously detects 10 bacterial, viral and protozoan including primary, secondary and asymptomatic co-infection for a complete infection profile. The assay is based on a combination of multiplex PCR and biochip array hybridisation. Innovative PCR priming technology permits high discrimination between multiple targets.
Respiratory tract infections are caused by many viral and bacterial pathogens and are the second most common cause of morbidity and mortality worldwide.2 The Respiratory Multiplex Array is the most comprehensive screening test for infections of both the upper and lower respiratory tracts, simultaneously detecting 22 bacterial and viral pathogens from a single sputum lavage or nasopharyngeal sample.
Both arrays detect the most common and frequently requested infections in sexual and respiratory health. These comprehensive, highly sensitive and specific tests enable identification of co-infections simultaneously, often in asymptomatic patients and enable antibiotic stewardship.
KRAS, BRAF, PIK3CA Array and Familial Hypercholesterolemia Arrays I & II
The colorectal cancer (CRC) is the third most common cancer worldwide. Overall, the lifetime risk of developing colorectal cancer is: about 1 in 22 (4.49%) for men and 1 in 24 (4.15%) for women.3 The KRAS, BRAF, PIK3CA Array simultaneously detects 20 point mutations within the KRAS, BRAF and PIK3CA genes. The assay is validated for use with the DNA extracted from fresh/frozen and formalin fixed paraffin embedded tissue. The array is CE marked for routine clinical use.
Familial Hypercholesterolemia (FH) is a genetic disorder of lipoprotein metabolism. 4It is the most common autosomal dominant, or inherited disease and affects the plasma clearance of LDL-cholesterol, resulting in premature onset of cardiovascular disease and higher mortality risk.5 Early diagnosis is crucial as by the time the FH sufferer enters early adulthood they will have accumulated >20 years of continuous exposure to build up of fatty or lipid masses in the arterial walls and are at the hundred-fold greater risk of a heart attack than other young people. The Familial Hypercholesterolemia (FH) Arrays I & II are rapid, simple and accurate detection of 40 FH-causing mutations within the LDLR ApoB and PCSK9 genes.
These unique biochip assays permit high discrimination between multiple targets in several genes with a rapid turnaround time (3 hours). The arrays enable detection of the most frequently occurring mutations known to cause disease (FH) and adversely affect patient treatment (KRAS, BRAF, PIK3CA). A unique primer set is designed for each target which will hybridise to a complimentary oligo-nucleotide probe spotted on a biochip discrete test region (DTR).
Cardiovascular Risk Prediction Array
Coronary Heart Disease is the leading cause of death in the developed world and its prevention is a core activity for public health systems worldwide.6 Randox have the Cardiac Risk Prediction Array which will allow for 19 SNPs to be genotyped simultaneously, which incorporate a test to identify patients predisposed to statin-induced myopathy.
This array identifies individuals with a genetic predisposition to coronary heart disease (CHD). The innovative multiplex primers are designed to discriminate DNA sequences which differ only at one base.
For more information on our Evidence Series or Molecular range of Assays, contact us at email@example.com
Randox Testing Services are delighted to announce that we will be attending the Northern Ireland Construction Expo. Titanic Exhibition Centre will be the venue for the event, taking place on 13th February.
The NI Construction Expo brings together over 2000 construction companies, developers, policy makers, project owners and a plethora of other organisations, to provide an environment of debate, further knowledge in the design, construction and management of Northern Ireland’s buildings, infrastructure and industrial projects.
Attending the event will be our Senior Business Development Executive David O’Regan and our Business Development Executive Jim Windsor. Both have many years’ experience in workplace drug and alcohol testing and they will be more than happy to answer any questions you have regarding implementing a workplace testing policy.
Our Sales Executive Jim Windsor will be speaking at the event, providing those in attendance how drug & alcohol testing in the construction industry can have a positive impact on a business in this safety-critical environment.
If you would like to arrange a meeting with our team, please contact firstname.lastname@example.org. We will be exhibiting at stand B11B, make sure you stop by and have a chat to our team for any drug & alcohol testing related queries you may have.
Randox Testing Services
Randox Testing Services is part of the Randox Laboratories group, a global market leader in the diagnostics industry with over 35 years’ experience. Founded in 1982 by current Managing Director, Dr Peter FitzGerald CBE FREng, Randox is dedicated to accurate and sensitive sample testing. The ethos within Randox is to produce quality products, supported by continual investment in research and development.
Randox Testing Services is a specialist in the drug and alcohol testing industry. Our expertise is relied upon by a range of leading safety-critical companies across the UK, Ireland and internationally, as well as the medico-legal sector.
Visit our website today for more information:
Medico-legal Testing: https://www.randoxtestingservices.com/medico-legal-testing/
Private Individuals: https://www.randoxtestingservices.com/private-individuals/
Phone: +44 (0) 161 741 2760
At Randox Testing Services we utilise discreet and non-invasive methods of drug & alcohol testing for comfort and fast sample collection. Offering a choice of a urine test, hair drug test, saliva drug test or a combination of tests, our drug testing methods ensure the possibility for short-term and long-term drug abuse profiling. With different drug testing methods having different windows of detection, we offer advice on which methods to utilise depending upon your company’s drug testing requirements, ensuring the best method or combination of methods is chosen to ensure all your testing needs are fulfilled.
Below we will provide a breakdown of each sample type and accompanying detection windows for the presence of illicit substances.
Urine – Drug & Alcohol Testing
Urine is the most common sample type for drug & alcohol testing. Simple and practical to obtain, it offers short-term drug abuse profiling. It is considered non-intrusive and sample collection is not observed.
Drugs: 4 hours – 8 days (30 days for regular cannabis users)
Alcohol: <12 hours
Oral Fluid – Drug Testing
Oral fluid testing analyses a saliva sample for parent drugs and their metabolites. Providing analysis of short-term drug abuse, an oral fluid test is used for with-cause testing and post-incident testing, with results detectable 30-60 minutes after ingestion.
Drugs: 24 hours – 48 hours after consumption (drug dependent)
Breath – Alcohol Testing
Breath can be tested for alcohol using handheld devices which provide immediate results. These devices are specific to alcohol and can gauge blood alcohol content (BAC) by measuring deep lung air. This type of testing can accurately determine whether a person has recently consumed alcohol or is currently over the legal or pre-determined limit.
Hair – Drug Testing
A hair drugs test offers a longer window of detection than alternative testing and provides a detailed month-on-month view of overall picture of drug use. This can highlight trends of drug use, suggest abstinence or show evidence of use depending on the length of the hair sample. Our hair testing services are tailored to meet the specific needs of our customers.
Typically, up to 90 days using a 3cm sample (1cm of head hair = 1-month detection).
Body hair can be used to provide extended window of up to 1 year
Randox Testing Services
At Randox Testing Services we are committed to improving the safety of workplaces who may be affected by drug & alcohol consumption. We offer a wide range of quality products designed to test for illegal substances quickly and efficiently, ensuring minimal disruption in your workplace.
To find out more about sample types and how they are utilised in workplace testing programs, click this link: http://bit.ly/RTS-samp
For more information on the different drugs we currently test for, click: http://bit.ly/RTS-drugstest
If you would like to find out more about our drug & alcohol testing programs, contact us today to speak to one of our experience business development executives.
Phone: +44 (0) 28 9445 1011
A hair drugs test offers a longer window of detection than alternative testing and provides a detailed month-on-month view and an overall picture of drug use. This can highlight trends of drug use, suggest abstinence or show evidence of use depending on the length of the hair sample.
When a drug is taken it is absorbed into the blood stream and circulated around the body. As a result, it is incorporated into the hair follicle meaning that as the hair grows, drugs are transferred into the hair strand. It can take up to 2 weeks for drug components to enter the hair and therefore analysis of a 3cm sample is recommended.
Randox Testing Services offer a combined analysis for hair alcohol testing as an aid in the determination of chronic excessive alcohol consumption. A combination test of alcohol markers ethyl glucuronide (EtG) and fatty acid ethyl esters (FAEE) help provide evidence to assess chronic excessive alcohol consumption but cannot be used to demonstrate abstinence of alcohol consumption.
This testing method is commonly used by employers for pre-employment screening which is an increasingly common type of workplace drug and alcohol testing. It forms an essential part of a company’s recruitment process. Hair testing is also heavily used in substance abuse assessment in child protection cases.
Body hair can be used to provide an extended window of up to 1 year of drug use.
Randox Testing Services
At Randox Testing Services we provide drug and alcohol testing to all professional bodies within the medico-legal sector and all workplaces from any industry. Through utilising innovative multiplex drug and alcohol screening methods as well as LC/GC mass spectrometry confirmatory analysis our complete service guarantees reliable and accurate results.
Our hair drug test along with all other testing services are flexible and can be tailored to our customer needs with a choice of testing methods. We offer a comprehensive drugs of abuse test menu and our service also includes expert witness reporting where applicable.
To get in touch with one of our experts about hair drug testing contact email@example.com or call +44 (0) 161 741 2760.
Figures released by the Home Office from the Crime Survey of England and Wales for 2017/2018 showed an 8.4 percent rise in 16-24 year olds using Class A drugs in the last year, compared to 7 percent in 2016/2017. As drugs are becoming more readily available due to the Dark Web, mobile phones and drug gangs, a broader network of distribution has been established and the price of cocaine has fallen.
Cocaine is a strong stimulant that comes in a powder (known as coke), freebase or crack form. With short lived effects, cocaine temporarily speeds up the mind and body. Freebase is a powder cocaine that has been prepared for smoking, whilst crack cocaine comes in a rock form. As both forms of cocaine can be smoked, they reach the brain quicker and have a stronger effect than powder cocaine. Injecting any form of the drug has serious risks including, damaged veins and the spread of blood-borne viruses, such as HIV and Hepatitis C. High doses of cocaine can cause the body temperature to rise, resulting in convulsions, a heart attack and heart failure.
The Telegraph recently reported that the fall in cocaine prices has now led to the highest number of young people using Class A drugs in over a decade, a rise from 4.8 percent in 2012/2013. The United Nation’s 2018 World Drug Report states that the street price for a gram of cocaine in the UK in 2016 was £41, the cheapest figure documented at the time since 1990. Compare this to cocaine prices in 2007 when it was £69 per gram.
“Our young people’s services have seen a significant rise in the use of Class A drugs”. Yasmin Batliwala, chair of London based drug and alcohol treatment charity WDP commented on the issue, “The primary drug of choice has always been alcohol, as well as cannabis, but certainly in the last two or more years the use of Class A drugs has increased substantially.” When cocaine and alcohol have been mixed it can cause particularly dangerous side effects and produce a toxic chemical called cocaethylene.
We have the Solution!
Randox Toxicology’s universally available patented Biochip Array Technology boasts cutting-edge multiplex testing capabilities, providing rapid and accurate drug detection from a single sample. Offering excellent cross-reactivity and unrivalled limits of detection, Biochip Array Technology’s intra and inter assay precision is typically <10% giving excellent correlation with confirmatory methods.
Persistently staying ahead of the ever-changing trends, Randox Toxicology are first to market with a range of tests for drugs of abuse, including the cocaine metabolite Benzoylecgonine (BZG). Utilising our Biochip Array Technology, Randox Toxicology’s DoA I, DoA I+, DoA ULTRA/DUID, DoA Evolution and DoA MultiSTAT panels all detect Benzoylecgonine.
Built on a foundation of continuous innovation, our research and development team continue to advance the future of toxicology through pioneering technology and novel tests. Offering the most advanced screening technology on the market, Randox Toxicology has transformed the landscape of drugs of abuse testing forever.
The global meat industry is a multi-billion-dollar business contributing over $85 billion to the US economy alone annually. Globally it is valued at $800 billion and as such, it is one of the biggest industries in the world.
With its already strong position and an ever growing demand for meat products the market shows no sign of slowing down. There are continued demands set on producers to provide not only more meat, but meat at a higher quality. Public awareness on issues such as drug residues, animal rights, food safety and antibiotic resistance is on the rise and as such producers and processors are more and more required to meet stringent requirements.
With the increasing demand on quantity and quality the industry faces many challenges and one the key areas of interest in this production chain is the monitoring of residues.
Residues in food relates to the residual amount of a particular compound either administered to an animal as a veterinary treatment or a naturally occurring compound present in food for human consumption.
There are a number of potential issues that can arise from contaminated feed and it is important for producers to ensure that animal feed has little or no trace of residues of mycotoxins, growth promoters or veterinary drugs.
Veterinary drugs are often added to feed to be used as a method of treating livestock, producers therefore must be sure of the dosage to ensure that withdrawal periods are correctly adhered to. Mycotoxins may also be present in feed due to a number of environmental factors, this can have a negative impact of the livestock.
The Mycotoxin Threat
Mycotoxins are naturally occurring toxins produced by fungi, commonly known as moulds, which can have a harmful effect on humans and livestock. These moulds are of interest to producers because they have the potential for significant economic losses due to how they impact human health, animal productivity and international trading.
Mycotoxins can be present in a wide variety of foods and feeds and are a particular threat in areas with climates of high temperature and humidity. They can enter the food or feed chain through contaminated crops, in particular cereals, poultry meat and kidneys, pig kidneys and pork sausages. Contamination may also occur post-harvest during storage, transport, and processing stages of the food or feed supply chain.
The establishment of mycotoxin limits and regulations have been set by multiple food agencies worldwide. For example the EU 2002-32 Directive sets maximum permitted levels (MPLs) for substances that are present in, or on, animal feed that have the potential to pose danger to animal or human health, to the environment, or could have an undesirable affect to livestock production.
One type of livestock that can be significantly impacted by mycotoxins are pigs. Pig feed contaminated with mycotoxins can cause serious risks to pig health.
For example, Aflatoxins consumed by swine can expose non-clinical characteristics with low level exposure (20 to 200 ppb), inducing symptoms displayed such as feed avoidance, gastrointestinal disturbances, paleness and slower growth. It can also suppress the immune system and cause young piglets to become more susceptible to bacterial, viral or parasitic diseases. With prolonged exposure causing a greater risk of cancer, liver damage and jaundice. High concentrations of aflatoxin (1,000 to 5,000 ppb) result in acute effects, including death. It is a genotoxic carcinogen and suitably its levels have been set as low as realistically possible in complete feeding stuffs for pigs and poultry with a maximum content value of 0.02.
Zearalenone is another mycotoxin that can have a negative impact on livestock. Produced by a strain of Fusarium graminearum it has been listed under the Directive with a guidance value. It has an estrogeneous action and is significantly toxic to the reproductive system of animals with the potential to cause rectal and vaginal prolapses in gilts (young sows). Zearalenone has been allocated a suggested guidance value of 0.1ppm in complementary and complete feeding stuffs for piglets and gilts and 0.25ppm in feedstuffs for sows and fattening pigs.
With the risk from multiple Mycotoxins in animal feed it is important to be able to detect dangerous levels of each listed in the EU Directive in order to reduce instances of damage to animal health.
Growth promoters are often used in the meat industry to increase yield of livestock, an important tool considering the increased demand on quantity from the food chain. Some of these growth promoters however are known to have a negative impact on both animal and human health.
The presence of anabolic steroids including beta agonists such as Clenbuterol and Ractopamine, as well as other veterinary drugs is under a strict monitoring program in meat and animal feed to prevent these negative impacts.
Growth promoting drugs are used to induce weight but can have various health concerns such as such as hospitalisation with reversible symptoms of increased heart rate, muscular tremors, headache, nausea, fever, and chills.
The potential human health risks highlight the importance of complete food safety testing before a food product reaches the public.
Due to the nature of the conditions livestock is generally kept in, there is a high potential for infection and spread of viruses. Producers need to be aware and proactive in treating any veterinary disease that arises.
One such disease that can be an issue is coccidiosis which is a parasitic disease of the intestinal tract. This disease can be spread by contact with infected faeces, or the ingestion of infected tissues by other animals. Coccisiostats are potent drugs which are widely used within veterinary practice to treat coccidiosis, mainly in feed additives. Chickens are susceptible to at least 11 species of coccidia that causes coccidiosis therefore creating an importance to treat for. Coccisiostat residues that occur in high levels within food for human consumption can be unsafe and can have negative effects on pre-existing coronary conditions/diseases. These residues can pass through the meat tissue and eggs.
With a variety of potential residues to be detected and a need for accurate results many producers are using Randox Food Diagnostics technology to carry out sample analysis.
With the development of the patented Biochip Array Technology Randox have consolidated the testing of multiple residues down to one sample which means time and cost saving for the meat industry. For example, with one Biochip a meat producer’s laboratory could test for 9 different growth promoter residues.
The technology centres on the Biochip, a 9mm2 ceramic chip which acts as the reaction well where samples are placed, requiring little technical expertise for preparation. Each chip is spotted with the antibodies required to detect the individual analytes being tested for and can accommodate up to 43 analytes. Food laboratories can then detect 43 different residues with one test.
The biochip works on the Evidence Investigator (Semi-Automated) and Evidence MultiSTAT(Automated) analysers. These analysers are used as the imaging stations for the biochips. Each spotted test site sends out a chemiluminescent signal which is detected by the analyser, processed, quantified and validated by the instrument software.
With a simple process, fast method and trusted results many of the world’s top meat producers are investing in Biochip Array Technology to ensure the safety and quality of their products.
For more information please contact us at: firstname.lastname@example.org.
Randox Testing Services offers high quality drug testing with use of our revolutionary Biochip Array Technology specifically optimised for drugs of abuse testing. This technology allows multiplex back-to-lab testing of different drugs from one sample and offers test consolidation for comprehensive testing at an affordable price.
With a comprehensive drugs of abuse test menu we are able to test for a range of different drugs. Drug testing packages can be customised to include multiple different drugs to test per sample.
Our drug testing methods ensure fast and simple sample collection. We have a variety of non-invasive methods for patient comfort including use of a urine sample, hair strand or oral fluid sample to test for specified drugs. Utilisation of different testing methods also ensures flexibility of drug abuse profiling with the ability to offer short-term drug abuse profiling via oral fluid and urine testing, long-term drug abuse profiling via hair testing or a combination of both.
Oral Fluid Testing
An oral fluid test can detect drugs for up to 48 hours after consumption. Providing analysis of short-term drug abuse, an oral fluid drug test is used by employers conducting for-cause and post-incident testing, as well as medico-legal solicitors who may require testing for abstinence of drugs.
An oral fluid test consists of obtaining a saliva sample from between the cheek and gums to analyse traces of drugs. This sample method is reliable due to the high concentrations of drug components which remain in the oral cavity for a period of time after drug consumption. Sample collection is taken quickly, easily and is non-invasive. The sample collection is also observed which ensures samples are not tampered with.
A urine test offers short-term detection of substance abuse. Alcohol is detectable in urine for less than 12 hours, and a urine drug test can detect traces of drugs from between 4 hours and up to 8 days (this may be extended for regular cannabis users to around 30 days). It is often used in a combination with hair testing to provide an enhanced time-line for drug and alcohol detection; therefore allowing analysis of chronic substance abuse.
As a simple and practical method it is used as the most common sample type for workplace drug and alcohol testing. It is also utilised when conducting family law testing to ensure no alcohol intake by someone who has been forbidden to consume alcohol by a court of law or someone who is on a drugs or alcohol rehabilitation program.
A urine test consists of gaining a urine sample from the individual securely. Due to the nature of the urine sample being deposited privately by the sample donor, measures need to be taken to ensure the sample is not tampered with. At Randox Testing Services samples are collected under strict chain of custody protocols to guarantee sample integrity for legally defensible testing. We also increase accuracy of results by testing for creatinine which is a simple method of testing the authenticity of the sample given and reduces false-negative results giving you confidence in these testing methods.
Hair testing is a long-term substance abuse profiling with a detection window of 90+ days. It is commonly used by recruiters and employers conducting pre-employment screening and is the most common sample type used for substance abuse assessment in child protection and medico-legal cases.
Hair testing involves taking a hair stand sample from an individual to detect if and approximately when someone has consumed drugs or alcohol. A 3cm sample is generally used to obtain a longer analysis of substance abuse.
When a drug is taken it is absorbed into the blood stream and circulated around the body. As a result it is incorporated into the hair follicle meaning that as the hair grows, drugs are transferred into the hair strand. It can take up to 2 weeks for drug components to enter the hair and therefore analysis of a 3cm sample is recommended.
Analysis of the hair strand allows traces of drugs to be detected to provide an overall picture of drug abuse or a month by month analysis. Segmentation of the hair sample to provide a detailed month-on-month view is advantageous as it can highlight trends of drug use and identify periods of abstinence or high level use. Body hair can be used in special circumstances however segmentation into a month by month analysis is not possible.
Randox Testing Services
Through utilising innovative multiplex drug and alcohol screening methods as well as LC/GC mass spectrometry confirmatory analysis our complete service guarantees reliable and accurate results.
For more information on our back-to-lab testing services contact us at email@example.com to speak with one of our experts.
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 . It has been shown to reduce hospital stay time, reduce complications, and improve adherence to treatment .
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 . 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.
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 :
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.
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.
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.
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 . 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:
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 .
A study by Price, Smith and Bruel  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 . 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.
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.
ISO 22870 requires POCT users should be trained in the theory and practice of IQC . Staff should be trained in every aspect of POCT including storage, preparation, frequency, documentation and basic troubleshooting.
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.
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.
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.
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).
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:
Conducting EQA in POCT
Below are some suggestions for how EQA should be conducted for POCT.
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).
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.
A regular review of past EQA results should be part of the cycle of quality.
A POCT EQA provider should be able to provide assistance when the user is having difficulties.
Individuals carrying out testing should have the correct knowledge to interpret results, choosing a scheme with easy to interpret results can help.
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
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.
RIQAS Point of Care
 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].
 C. Price, “Point of care testing”, BMJ, vol. 322, pp. 1285-1288, 2001.
 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].
 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.
 “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].
 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.
 A. Stavelin and S. Sandberg, “Essential aspects of external quality assurance for point-of-care testing”, Biochemia Medica, pp. 81-85, 2017.
 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.
 “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].
 J. Crilly, “Mythbusting: Frequency of EQA Reports”, Randox Laboratories, 2017.
 G. Kristensen and P. Meijer, “Interpretation of EQA results and EQA-based trouble shooting”, Biochemia Medica, pp. 49-62, 2017.
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 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.
Read more about accreditation: ‘The Importance of Meeting ISO 15189 Requirements’.
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 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 .
A good EQA scheme should offer:
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.
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.
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:
• Incorrect sample handling during preparation, shipping or storage
• Improper storage
• The material has expired
• An error in manufacturing
• Instrument, calibration or reagent defects
• Staff competency
• Matrix effects
• Incorrect analysis method
• Report misinterpretation
• Clerical or transcription errors
• Failure to take corrective action
• 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 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
RIQAS Point of Care
 WHO, Overview of External Quality Assessment (EQA). World Health Organisation, 2009.
 ISO 15189:2012 Medical laboratories — Requirements for quality and competence, 3rd ed. ISO, 2014.
 ISO 22870:2016 Point-of-care testing (POCT) — Requirements for quality and competence, 2nd ed. ISO, 2016.
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