Orion Diagnostica QuikRead CRP Manual De Instrucciones página 2

QuikRead CRP
®
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
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)
microparticles, and the resultant change in the turbidity of the solution is measured by the
QuikRead 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
Contents
QuikRead CRP kit
®
CRP Reagent Caps
Buffer
Cuvettes
Magnetic card
Instructions for use
Capillaries (20 μl)
Plungers
Reagents contain sodium azide, please see Section 5 "Warnings and precautions".
Storage
Kit component
Reagent caps
(in opened and
unopened
aluminium tube)
Buffer
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 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.
Analytical precautions
● Do not use the product after the expiry date marked on the outer package.
● Do not mix components from different lot numbers or different tests. The components
are disposable; never reuse components already used for performing a test.
● 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.
● Make sure that the correct magnetic
card for the QuikRead CRP test is used.
The magnetic card must not be bent or
exposed to liquids or strong magnetic
fields.
● Make sure that the dispenser is properly
cleaned when taking a new reagent kit
into use.
● Always check before use that there are
no air bubbles in the dispenser tubes.
Remove any air bubbles by dispensing
the buffer once before actual use.
● Do not splash liquid into the measuring
well of the instrument.
6 Sample collection and preparation
6.1 Fingertip whole blood
Prick the finger with a lancet and discard the first drop. Wipe the
finger and collect 20 μl of blood from the second drop in a glass
capillary. Perform the test as outlined in Section 7 "Procedure".
Use of capillaries and plungers
The QuikRead CRP kit Cat. No. 67961 contains 20 μl glass
capillaries and plungers, which are recommended for adding
the sample. Insert the plunger into the capillary at the end with
the blue stripe. Fill the capillary with sample up to the white
stopper. Ensure that there are no air bubbles in the capillary.
Use a soft tissue to wipe excess sample from the outer surface
101 Instrument. For in vitro diagnostic use.
®
.
2
fragments. The CRP present in the sample reacts with the
2
.
7
Symbol
-
Symbol Storage at 2...8°C
Until the expiry date
of the kit
Until the expiry date
of the kit
Cat. No. 67961
50 assays
2 x 25
120 ml
50
1
1
50
50
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
English
. Any
1
.
2–6