Warnings And Precautions - Orion Diagnostica QuikRead 101 Manual De Instrucciones

QuikRead
1 Intended use
For quantitative determination of CRP (C-reactive protein) in whole blood, serum or plasma,
using the QuikRead
2 Summary and explanation of the test
CRP is an acute phase protein present in low concentrations in healthy individuals
Any pathological condition associated with invasive bacterial infection, inflammation
or tissue destruction is accompanied by elevation of the CRP level in the patient's
serum. The rise in CRP levels is rapid, and increased levels can be detected within
6 to 12 hours of the onset of the inflammatory process
Quantitative measurement of the CRP concentration has been reported to be a sensitive
indicator of the efficacy of antimicrobial therapy and the course of bacterial infections, as
well as an effective tool in controlling and monitoring postoperative infections
3 Principles of the procedure
QuikRead CRP is an immunoturbidimetric test based on microparticles coated with anti-
human CRP F(ab)
and the resultant change in the turbidity of the solution is measured by the QuikRead 101
instrument.
The sample is added to the assay buffer. The blood cells in whole blood sample are
haemolysed. The assay is performed in the same cuvette. The reagents are precalibrated,
and the calibration curve, which is lot-specific, is coded on a magnetic card provided with
each kit.
QuikRead CRP correlates well with results obtained using immunoturbidimetric and other
standard laboratory methods
4 Reagents
Content of the kit
Component
name and origin
QuikRead
®
CRP Reagent Caps
Buffer in prefilled
cuvettes
Capillaries (20 µl)
Plungers
Magnetic card
Instructions for use
Reagents contain sodium azide, please see Section 5 "Warnings and precautions".
Storage
Kit component
Reagent caps
(in opened and
unopened aluminium tube)
Prefilled cuvettes
in unopened foil pouches
Prefilled cuvettes
without the foil pouch
Opened prefilled cuvette
Mark the date of opening the foil pouch on the cuvette rack.
Reagent preparation and storage conditions
All reagents are ready to use. Keep the CRP 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.
5

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.
● All patient samples and controls should be handled as potentially infectious material.
● Lyophilised reagent contains < 1% sodium azide, which is harmful to aquatic life with
long lasting effects (Aquatic Chronic 3, 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
Analytical precautions
● Do not use the product after the expiry date marked on the outer package.
● Do not exceed the stability periods for opened reagents.
● Do not mix components from different lot numbers or different tests. The components
are disposable; never reuse components already used for performing a test.
● When opening a kit for the first time, ensure that the foil pouches (2 pcs) protecting
the cuvettes are intact. If a foil pouch is damaged, do not use the cuvettes inside it. In
addition, always ensure before using and individual cuvette that its foil covering is intact.
● Do not touch the clear flat surfaces on the lower part of the cuvette (optical part). Discard
any cuvettes with fingerprints.
● QuikRead CRP Reagent Caps are colour-coded blue to distinguish them from other
QuikRead analytes.
● Keep the QuikRead CRP Reagent Caps away from moisture. Close the aluminium tube
immediately after taking out the required number of reagent caps.
CRP
®
101 instrument. For in vitro diagnostic use.
®
fragments. The CRP present in the sample reacts with the microparticles,
2
.
7
Symbol
Storage at 2...8°C
Until the expiry date
of the kit
Until the expiry date
of the kit
6 months
2 h
2
QuikRead CRP,
®
Cat. No. 134191
50 assays
2 x 25
50 x 1 ml
50
50
1
.
QuikRead
Cat. No. 134192
50 assays
Storage at 18...25°C
24 h per day – 1 month
7.5 h per day – 3 months
Until the expiry date
of the kit
3 months
2 h
English
1
.
2–6
CRP,
®
2 x 25
50 x 1 ml
–
–
1
.