Una Health Reflotron Plus Installation guide

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Reflotron® Plus
TrainingManual

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CONTACTS
Una Health Ltd – Customer Support 01782 575180

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CONTENTS
Overview and Scope of this Training Guide
7
CLINICAL BACKGROUND 9
PRINCIPALS OF METHOD
13
HAZARD WARNINGS 18
RESPONSIBILITIES 19
COLLECTION PROCEDURES 20
SPECIMEN REQUIREMENTS 21
EQUIPMENT/REAGENTS
The Instrument
Operational details
The Reagents
Operational procedure
22
METHOD
Stage 1 - Preparation of the Test System
Stage 2 – Performing the test
Stage 3 - Reviewing the Results
26
INTERNAL QUALITY CONTROL (IQC)
Running a Quality Control (QC) 36
Training/Competency Assessment 40
Training Knowledge Assessment 42
Appendix 1 - Basic troubleshooting 46
Appendix 2 – Test strip general information 47
Appendix 3 – Key board functions 48
Appendix 4 – Risk Assessment 49
Appendix 5 – COSHH 51
References 54

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Overview and Scope of this Training Guide
The training session will cover the contents of this guide. It is not intended as a
replacement for the Reflotron® Plus user manual nor is it intended to replace the
inserts that are supplied with the individual test kits, but will provide a good basic
understanding of the system.
During the training session you will be given the opportunity to practice taking
blood, run samples and QC and ask any questions you may have.
The training guide covers the following topics:
•Introduction/Clinical Background
•Principals of Method
•Collection Procedures
•Specimen Requirements
•Equipment/Reagents
•Operational procedure
•Reporting/Reviewing Results
•Quality Control & Calibration
•Training/Competency Assessment
•Knowledge Assessment
•Basic Troubleshooting
•Risk Assessment
•COSHH/MSDS
At the end of the training session you will have:
•a signed Training/Competency Assessment
•a signed Knowledge Assessment
•a signed Risk Assessment
•a Certificate

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CLINICAL BACKGROUND
(All information, instructions and pictures referring to the Reflotron® Plus Analyser and Reagent Test strips are
taken from the Roche/Diavant website and courtesy of E C Hamer BSc(Hons), MSc, FIBMS.)
With the 17 clinical-chemical parameters detectable by the available Reflotron®®
Test Strips, the most important indications in primary care are covered for such
health problems as diabetes, lipid disorders, kidney diseases, muscle diseases,
anaemia, liver diseases, pancreatitis, gout, and bone disorders.
Alkaline Phosphatase (ALP)
The main indications for determination of alkaline phosphatase (ALP) are suspicion
of cholestatic liver disease, bone disease and skeletal involvement of other primary
diseases. In most cases other additional tests are needed to differentiate the cause
of abnormal ALP values
Amylase
α-Amylase is mainly formed in the parotid gland and the pancreas. Under normal
conditions serum amylase consists of about 40 % pancreatic amylase and 60 %
salivary amylase. Elevated serum α-Amylase levels are most often seen in
pancreatitis, so a α-Amylase determination is primarily carried out for diagnosis and
therapeutic monitoring of acute as well as of chronic pancreatitis.
Pancreatic Amylase
The real diagnostic value of the pancreatic amylase - in contrast to total amylase - is
its usefulness in screening for pancreatitis because of the very high sensitivity and
specificity of the test
Bilirubin
Bilirubin is a yellow-brown bile pigment which is responsible for the yellow-brown
colour in serum. Bilirubin is a substrate that is mainly produced during the
degeneration of haemoglobin in the liver-spleen system. There are two kinds of
bilirubin. The first one is bound to albumin, and called “unconjugated” or indirect
bilirubin. The second type of bilirubin is, in contrast to the first, conjugated with
glucuronic acid and therefore known as “conjugated” or “direct bilirubin”. This
conjugation takes place in the liver cells. Therefore the differentiation allows
conclusions to be made about the origin of bilirubin.
Jaundice occurs when the bilirubin concentration rises above approximately 2 mg
per 100 ml serum. The most common forms of are characterised by an increase of
conjugated bilirubin.

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Glucose
Measurement of blood glucose is predominantly indicated to screen for, to detect
and to control hyperglycaemia due to diabetes mellitus as well as to monitor its
treatment. Also, it serves to diagnose suspected hypoglycaemia. Impaired fasting
glucose and impaired glucose tolerance are observed as pre-diabetes, and they are
associated with a high risk for developing diabetes. There is also growing evidence
that people with impaired fasting glucose are at an increased risk for micro- and
macrovascular complications. The recognition of diabetes and following the progress
of the disease in primary care are of prime importance in the medical practice
Creatine Kinase / CK
Creatine kinase (CK) is an enzyme that mainly occurs in muscles, heart and brain.
Determination of CK activity is used for the diagnosis and monitoring of myocardial
infarction and the monitoring of muscle diseases such as Duchenne progressive
muscular dystrophy. Coronary heart disease and similar diseases are among the
most frequent causes of death or early invalidity. In myocardial damage, such as in
acute myocardial infarction, CK is released from destroyed myocardial cells. An
increase of CK activity in the blood can be detected as early as 4 hours after the
infarction. CK activity reaches its peak after 12 - 24 hours and returns to the
reference range after 4 - 5 days
Haemoglobin
Haemoglobin (Hb) is the red blood pigment of the erythrocytes. It is the major carrier
of the iron contained in the body (approx. 70 %). The function of haemoglobin is to
transport oxygen from the lungs to the tissues, and the carbon dioxide produced by
metabolism from the tissues back to the lungs. Decreased levels of haemoglobin
together with haematocrit and red blood cell count indicate anaemia, so screening
the haemoglobin value is useful for the diagnosis of anaemia, the assessment of the
course of disease and response to treatment.
In addition the diagnosis has to be based on case history, clinical examination and
laboratory results.
Cholesterol
Determination of total cholesterol is essential for primary and secondary prevention
of cardiovascular diseases, since it is the prime risk factor for atherosclerosis and
coronary heart disease (CHD). Therefore accurate measurement of cholesterol level
is a mandatory part of CHD risk assessment. Attention should also be paid to the
assessment of HDL cholesterol, LDL cholesterol, and triglycerides as independent
CHD risk factors

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HDL
High-density lipoprotein cholesterol (HDL cholesterol) has anti-atherosclerotic and
cardio protective properties. For this reason, there is an inverse association between
HDL cholesterol and cardiovascular risk. A low HDL cholesterol level is an
independent risk factor for atherosclerosis and coronary heart disease (CHD), even
in individuals with low LDL cholesterol levels. HDL cholesterol levels should
therefore routinely be assessed by primary care providers as part of a lipid profile
which also includes total cholesterol, LDL cholesterol, and triglycerides.
Triglycerides
Up to 30 percent of the population has elevated triglyceride values. Elevated
triglyceride levels are an independent risk factor for cardiovascular diseases,
commonly associated with other lipid and non lipid risk factors (e.g. high blood
pressure), and metabolic diseases such as diabetes and obesity. Elevation of both
LDL cholesterol and triglycerides indicates a particularly high cardiovascular risk.
Thus the need to detect, monitor and treat elevated triglyceride levels in order to
prevent cardiovascular diseases is of high importance.
GGT
γ(Gamma)-Glutamyltransferase (GGT) is a highly sensitive parameter for numerous
disorders with involvement of the liver, but it can also be found in pancreatic, renal
disorders, and myocardial infarction. Usually it is regarded as one of the enzymes
that indicate cholestasis. As GGT values rise before liver damage becomes evident
this enzyme is especially important for diagnosis of anicteric or symptomless forms
of disease. If the values increase two-fold or more above the upper reference level, a
parenchymal liver damage has to be considered.
However, unexplained mild elevations are common and may occur even after
moderate alcohol intake. For differential diagnosis it is therefore reasonable to take
into account other enzyme parameters like GPT, GOT, ALP or bilirubin, in addition to
GGT.
GOT (AST)
Glutamic-oxaloacetic transaminase (GOT) - also known as aspartate
aminotransferase or AST, is an enzyme found in the mitochondrion and cytoplasm of
all cells. The evaluation of GOT (AST) activity is a basic procedure for the diagnosis
and the monitoring of hepatocellular disorders or muscle damage. The increase in
GOT (AST) correlates in general well with the extent and severity of cellular damage.
The differential diagnosis of liver disease requires the determination of GPT, ALP &
GGT in addition to GOT. The ratios of creatine kinase/GOT and GOT/GPT may
provide further information about the organ damaged (liver vs. muscle) and the
severity of the disease.

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GPT (ALT)
Glutamic-pyruvic transaminase (GPT) - also known as alanine aminotransferase or
ALT - is a cytoplasmic hepatocellular enzyme, whose increase in blood is highly
indicative for liver damage, e.g. by hepatitis, cirrhosis or hepatic tumours.
Serum values more than 15-fold above the upper reference limit always indicate an
acute hepatocellular damage of either viral, toxic or circulatory origin. In most types
of liver disease GPT activity is higher than that of GOT, an exception is in alcoholic
hepatitis. The ratio of GPT and GOT may provide further information about the
severity of the disease and may serve as a prognostic indicator
Potassium
The human body normally contains approximately 50 mmol potassium per kg body
weight. 98 % of it is found in cells and only 2 % is found in extra-cellular fluids. This
concentration gradient plays a major role in maintaining the membrane potential of
the cells. This electric potential is responsible for the excitability of muscles and
nerves - including the heart. Potassium is also influenced by acid-base disturbances
(e.g. treatment of very high blood glucose concentrations with insulin, which can
cause hypokalaemia). Potassium is mainly excreted by the kidneys (90 %) and to a
minor degree in the faeces (10 %).
Disorders of the water and electrolyte balance occur mainly as a consequence of
other diseases. They may characteristically alter the underlying disease or may
occur as a complication of the clinical picture.
Creatinine
Creatinine is the most important marker for renal function, because it is steadily
produced in the muscles and excreted via the kidneys in the urine. Renal
insufficiency will cause a rise in serum creatinine levels because it is not excreted in
the normal quantities and accumulates in the blood.
Urea
Urea is the most important breakdown product of protein metabolism and is
produced in the liver. Adults accumulate approximately 16 g of urea daily. This
amount is mainly eliminated via the kidneys through glomerular filtration. About 40 -
50 % of urea is partially reabsorbed in the tubules. The rest is excreted via the
intestines and perspiration.
Elevated urea levels are a clearly indication of renal insufficiency, but creatinine and
urea do not reflect renal insufficiency to the same degree. Therefore both
parameters should be tested at the same time to determine the degree of renal
insufficiency.

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Uric acid
Uric acid is the end product of purine metabolism. A large proportion of the purines in
food will be reused, while the rest is degraded to uric acid. Up to 70 - 80 % of uric
acid is excreted via the kidneys, and an additional 20 - 30 % leaves the body via the
intestines.
Hyperuricaemia is the hallmark of gout. In most cases hyperuricaemia is due to a
disorder of uric acid excretion by the kidneys. In rare cases, it is caused by an
enzyme defect resulting in an increase of purine degradation and overproduction of
uric acid. Determination of the uric acid concentration in the blood allows you to
evaluate the patient's risk, to diagnose and to monitor the therapy of gout or kidney
stones.
PRINCIPLES OF METHOD
The Reflotron®®Plus is an in vitro diagnostic device designed for the quantitative
determination of clinical chemistry parameters using Reflotron®®Test reagent strips.
It works on the principle of reflectance photometry and ensures rapid and reliable
results while being easy to use.
An incorporated plasma separating system in the Test strips make it possible to use
whole blood (capillary or venous) aswell as plasma and serum,
A reflectance measurement is recorded based on the colour change on the test
strip:
Measuring range >>20 – 1250U/L
Measuring Range >> 29 – 860U/L

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Measuring Range >>8.5 - 205µmol/L
Measuring Range >>2.59 – 12.9 mmol/L
Measuring Range >> 370C 24.4 - 1400 IU/L
300C 15.4 - 900 IU/L
250C 10.0 - 600 IU/L

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Measuring Range >>44.5 - 884 µmol/L
Measuring Range >> 370C 5.0 - 3500U/L
300C 3.85 - 2700U/L
250C 2.80 - 2000U/L
Measuring Range >>0.56 – 33.3mmol/L

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Measuring Range >> 370C 5.0 - 500U/L
300C 3.25 - 325U/L
250C 2.25 - 225U/L
Measuring Range >> 370C 5.0 - 2000U/L
300C 3.8 - 1520U/L
250C 2.66 - 1060U/L
Measuring Range >>0.26 – 2.59mmol/L

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Measuring Range >>5.0 – 20.0g/dl
Measuring Range >>14 - 850U/L
Measuring Range >>0.80 – 6.86mmol/L

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Measuring Range >>3.33 – 50.0mmol/L
Measuring Range >>120 - 1190µmol/L
Measuring Range >>2.0 – 12.0mmol/L
LDL cholesterol may be calculated using Cholesterol, Triglycerides, HDL results and
the Friedewald formula in the inbuilt software
HAZARD WARNINGS
See COSHH & Risk Assessments (Appendix 4 & 5)

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RESPONSIBILITIES
Personal Liability
The healthcare provider on duty at the time a person accesses the service has
overall responsibility for the service provision, whether or not they are personally
undertaking the test.
It must be someone who has been trained by Una Health Ltd that undertakes the
test.
Consultation area requirements
The consultation area must be used to conduct the blood test and to communicate
results. Ensure:
•It is clean and tidy – a cleaning and disinfecting rota should be in place to
ensure that cleanliness standards are achieved.
•It has 2 chairs & small table (or suitable workbench).
•Access to a supply of warm water.
•The paperwork, support material & equipment are available.
•Relevant health advice leaflets & information are on display.
Health & Safety
•Any accidental blood contamination of equipment or surfaces must be cleaned
immediately with disinfectant in accordance with standard operating
procedures, whist still wearing protective clothing.
•Personal Protective Equipment (PPE) must be available at all times
•No food or drink is consumed in the area.
•No smoking allowed in the area.
•Correct waste disposal procedures are followed according to standard
operating procedures.
(UK Health Depts., Guidance for Clinical Healthcare Workers: Protection against infection with Blood Bourne
Viruses, Dept. Of Health (DOH) 1998)

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COLLECTION PROCEDURES
Sample type – requires fingerstick collection of whole blood
Healthcare provider must:
•Wash & dry their hands thoroughly
•Ensure any cuts or grazes are covered with a plaster
•Put on protective gloves
Ask the client to wash & dry their hands thoroughly, if there is no sink in the
consultation area you should supply the client with:
•A small bowl of hot soapy water and paper towels to dry their hands OR
•A non alcohol based hand cleaning solution that does not require water
•Ask client to rub hands together to induce better circulation
•Offer a plaster at the end of the procedure
The following procedure should be adopted if the client feels unwell at any time
during the test
•Stop the test
•Allow the client to remain seated until they feel well again
•Offer the client a drink of water
•After recovery, ask the client if they wish to proceed with the test
•Arrange an alternative appointment if required
The following procedure should be adopted if there is any risk that exposure to
Hepatitis B infection has taken place e.g. blood to blood contact
•Immediately wash out the wound thoroughly with soap & water
•Immediately contact the nearest hospital accident & emergency dept to seek
medical advice
•Record the incident in the accident book
•Advise the Line Manager
(UK Health Depts., Guidance for Clinical Healthcare Workers: Protection against infection with Blood
Bourne Viruses, Dept. Of Health (DOH) 1998)