Performance Characteristics - Orion Diagnostica QuikRead 101 Manual De Instrucciones

10 Limitations of the procedure
QuikRead FOB quantitative measures haemoglobin in the faecal sample. Since bowel
lesions may not bleed at all or may bleed intermittently, or the blood may be unevenly
distributed in the faecal sample, a test result may be negative even in cases with occasional
bleeding. Healthy persons may have blood in their faeces because of physical stress
or intake of certain medications that may cause gastrointestinal irritation resulting in
gastrointestinal bleeding.
As with any FOB test, QuikRead FOB quantitative may not be considered conclusive proof
of gastro intestinal bleeding or pathology. FOB test results should always be interpreted in
the light of the patient's symptoms and current diagnostic criteria.
Faecal occult blood tests are not intended to replace other diagnostic procedures such
as sigmoidoscopy, colonoscopy or X-ray studies but are to be regarded as preliminary
screening methods or aids to diagnosis.
11 Expected values
In a healthy person, there should be no haemoglobin or a minimal amount of haemoglobin
(physiological bleeding) in faeces, see "Limitations of method". The result obtained should
be "NEGATIVE FOB".

12 Performance characteristics

Precision
A precision study
9
Standards Institute (CLSI) guideline EP5-A2.
Sample
Sample 1
Sample 2
Sample 3
Sample 4
Correlation
In a study 196 randomly selected outpatients – both symptomatic and asymptomatic – were
tested with QuikRead FOB (software version 8.03, qualitative version). All of these patients
also underwent colonoscopy. The results obtained with QuikRead FOB were in accordance
with the colonoscopy findings. QuikRead FOB correctly identified the patients with
carcinomas. Moreover, among the 104 asymptomatic patients, QuikRead FOB correctly
identified those who should undergo further investigations.
Antigen excess
Haemoglobin concentrations less than 500 µg/ml (< 100 mg haemoglobin in 1 g faeces) do
not give falsely negative results.
Interfering substances
No interference with vitamin C at concentrations less than 100 µg/ml, an amount
corresponding to a daily intake of approx. 2 g ascorbic acid, has been observed. Iron
supplementation does not interfere with the measurement.
Measurement range
QuikRead FOB quantitative gives a negative result with all QuikRead 101 software versions
when the haemoglobin concentration in the QuikRead FOB Sampling vial is < 100 ng/ml
(0.1 µg/ml). This concentration is equivalent to < 20 µg haemoglobin/1 g faeces when the
sampling has been performed according to the instructions (~ 10 mg of faeces in 2 ml buffer
of the sampling tube). The result is shown on the display as "NEGATIVE FOB".
QuikRead FOB quantitative in QuikRead 101 with software version 8.03 or older gives a
positive result when the haemoglobin content of the QuikRead FOB sampling vial is ≥ 0.1
µg/ml (≥ 20 µg haemoglobin/1 g faeces). The result is shown on the display as "POSITIVE
FOB".
QuikRead FOB quantitative in QuikRead 101 with software version 9.0 or newer giving
positive result is shown either as concentration in ng/ml (within range 100‒1000 ng/ml which
equals 20‒200 µg haemoglobin in 1 g of faeces) or as "POSITIVE FOB > 1000 ng/ml" (>
200 µg haemoglobin/1 g faeces).
13 Traceability
Each batch is tested against reference material of human origin. The haemoglobin content
of this reference material has been verified with a method comparable to the International
Council for Standardization in Haematology (ICSH) reference method.
14 Disposal
● Dispose of contents according to national and local law.
● All patient samples, sampling devices, controls, used tubes, caps and cuvettes should
be handled and disposed of as potentially infectious material.
● Materials of the components of the QuikRead 101 and QuikRead go kits:
Paper: Instructions for use
Cardboard: Kit box including its inner parts
Plastic: Cuvettes, reagent caps, foil covering cuvette rack, cuvette rack, plungers,
extraction vials and tubes, plunger and capillary tubes
Glass: Capillaries
Metal: Reagent cap tubes, cuvette lids, plunger and capillary tube caps
Not to be recycled: Lids of reagent cap tubes (several) and magnetic cards (PVC)
● When used in accordance with Good Laboratory Practice, good occupational hygiene
and the instructions for use, the reagents supplied should not present a hazard to health.
15 Troubleshooting
For troubleshooting, check "Analytical precautions" (chapter 5) and/or see also the
QuikRead 101 Operator's Manual.
was performed by the manufacturer according to Clinical and Laboratory
Within-run, between-day and total precision
Number of Mean Hb
days (ng/ml)
20 128
20 183
20 418
20 651
9
Within-run Between-day
CV (%) CV (%)
4.6 9.1
3.7 7.7
4.4 8.4
4.3 1.6
9
9
Total
CV (%)
12.7
9.8
9.6
6.4