Intended Use; Warnings And Precautions - Orion Diagnostica QuikRead 101 Manual De Instrucciones

QuikRead
1

Intended use

QuikRead FOB quantitative is a test for the detection and quantification of occult blood
®
in human faeces in cases of suspected bleeding from the lower gastrointestinal tract. The
measurement is carried out with the QuikRead
For in vitro diagnostic use only.
2 Summary and explanation of the test
The faecal haemoglobin (Hb) concentration varies with gender and age, being higher for
males than females and increasing by age for both genders.
Tumour Markers (EGTM) recommends the use of quantitative, immunological faecal occult
blood (FOB) tests which enable the clinician to set the appropriate cut-off value.
also be possible to express faecal Hb results as micrograms of Hb per gram of faeces,
especially when comparing various methods.
A high FOB value may indicate that the patient has large polyps or colorectal cancer (CRC).
It usually takes 10 to 15 years for the first abnormal cells to develop into cancer. If these are
detected and removed in time, the patient has near 100 % reduction in risk of developing
CRC.
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The lifetime risk of developing colorectal cancer (CRC) is about 1 in 20.
annual incidence of CRC is predicted to increase from 432 000 new cases in 2008 to over
500 000 in 2020. Annual mortality is estimated to increase in the same proportion, reaching
approx. 250 000 cases.
can be significantly reduced by systematic screening programmes using immunochemical
FOB tests. Both the Council of Europe and the American College of Physicians recommend
regular CRC screening for people with no known risk factors to begin at the age of 50.
Immunological FOB tests – iFOBTs – have brought significant improvement in analytical
specificity.
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3 Principles of the procedure
QuikRead FOB quantitative is an immunoturbidimetric test based on microparticles coated
with porcine anti-human haemoglobin antibodies. The haemoglobin present in the sample
reacts with the microparticles, and the resultant change in the turbidity of the solution is
measured by the QuikRead 101 Instrument.
The faecal sample is first prediluted in the QuikRead FOB Sampling vial. Three (3) drops
of the prediluted sample are added to the prefilled QuikRead cuvette. The reagents are
precalibrated, and the calibration curve (which is lot specific) is coded on the magnetic card
provided with each kit.
The instrument will indicate the presence of haemoglobin by displaying the detected
concentration as ng/ml or as text FOB POSITIVE, depending on the instrument and
software version used.
4 Reagents
Content of the kit
Component name
and origin
FOB Reagent Caps
Buffer in prefilled cuvettes
Magnetic card
Instructions for use
Reagents contain sodium azide, please see Section 5 "Warnings and precautions".
Storage
Kit component
Reagent caps
Prefilled cuvettes in un-
opened foil pouches
Prefilled cuvettes
without the foil pouch
Opened prefilled cuvette
Mark on the cuvette rack the date on which the foil pouch was opened.
Reagent preparation and storage conditions
All reagents are ready to use. Keep the FOB Reagent Caps away from moisture. Close the
aluminium tube immediately after taking out the required number of reagent caps.
Reagent deterioration
The product should be used only if the buffer volume in the cuvette is correct. Check that
the liquid surface is between the two lines marked on the cuvette. Do not use a cuvette with
visible dirt in the buffer.
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Warnings and precautions

Health and safety information
● For in vitro diagnostic use only.
● Do not smoke, eat or drink in premises where samples or kit reagents are handled.
Wear suitable personal protective clothing and disposable gloves when handling patient
samples and kit reagents. Wash hands thoroughly when finished performing the test.
● Avoid contact with skin and eyes. After contact with skin, wash immediately with plenty
of water.
● Do not drink the liquid in the sampling tube.
● All patient samples and controls should be handled as potentially infectious material.
● Lyophilised reagents contain < 1% sodium azide (Aquatic Chronic 3). Harmful to aquatic
life with long lasting effects (H412). Avoid release to the environment (P273). Dispose of
contents according to national and local law (P501).
Reconstituted and liquid reagents contain <0.1% sodium azide, which is not considered
a harmful concentration.
● Sodium azide liberates toxic gas when in contact with acids. Azides may react with metal
plumbing, forming explosive compounds. Azide build-up can be avoided by flushing with
a large volume of water when disposing of the reagents.
● Disposal: see Chapter 14.
FOB quantitative
®
Several studies have shown that CRC incidence and mortality
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Symbol
Storage at 2...8 °C
Until the expiry date of
the kit
Until the expiry date of
the kit
6 months
2 hours
101 Instrument.
®
3
QuikRead
Cat. No. 138820, 50 tests
2 x 25
2 x 25 x 1 ml
1
Storage at 18...25 °C
24 hours per day – 1 month
8 hours per day – 3 months
Until the expiry date of the kit
3 months
2 hours
English
The European Group on
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2
In Europe, the
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FOB quantitative
®
It should
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