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Idiomas disponibles
QuikRead go
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Intended use
The QuikRead go CRP+Hb test is intended for quantitative determination of CRP (C-reactive
protein) in whole blood, serum and plasma and for quantitative determination of hemoglobin
(Hb) in whole blood using the QuikRead go instrument. For in vitro diagnostic use only.
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Summary and explanation of the test
CRP
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
Hemoglobin
Hemoglobin is the iron-containing protein in red blood cells that carries oxygen. Determining
its concentration is a common procedure in both primary health care and acute care. A
decrease in the hemoglobin concentration may follow from an iron deficiency or loss of
blood. An elevated concentration of hemoglobin in blood may indicate a low oxygen supply,
e.g. in those living in mountain regions or in smokers.
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Principles of the procedure
CRP
The CRP measurement of the QuikRead go CRP+Hb test is turbidimetric and it is based
on the agglutination reaction between microparticles coated with anti-human CRP
F(ab)
fragments. The CRP present in the sample reacts with the microparticles, and
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the resultant change in the turbidity of the solution is measured by the QuikRead go
instrument. QuikRead go CRP correlates well with other immunoturbidimetric methods.
The buffer haemolyses the blood cells in a cuvette, and the agglutination reaction is
measured after adding the reagent. Test calibration data is in the bar code label of the
cuvette and it is read by the QuikRead go instrument before the test is started. The CRP
value is automatically corrected according to the sample's hematocrit level. Hematocrit
results are not displayed but used in calculations.
Hemoglobin (Hb)
The hemoglobin measurement using the QuikRead go CRP+Hb test is based on measuring
oxyhemoglobin photometrically at two wavelengths. The buffer haemolyses the sample's
red blood cells in the cuvette, whereupon the absorption of released hemoglobin can be
measured. The instrument corrects the effect of lipids or other turbidity-inducing factors on
the results. The bar code on the cuvette contains the required parameters for calculating
the hemoglobin concentration, and the QuikRead go instrument displays the obtained
hemoglobin results.
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Reagents
Content of the kit
Component name and origin
CRP reagent caps
Cuvettes prefilled with buffer
Capillaries (20 µl)
Plungers
Instructions for use
Reagents contain sodium azide, please see Section 5 "Warnings and precautions".
Reagent storage
Reagent
CRP Reagent caps
(in opened and unopened
aluminium tube)
Prefilled cuvettes
in unopened foil pouches
Unopened 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.
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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.
●
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.
●
The buffer contains mixture of methylchloroisothiazolinone
methylisothiazolinone (Skin Sens 1). May cause an allergic skin
reaction (H317). Do not get in eyes, on skin, or on clothing (P262).
Wear protective gloves/protective clothing/eye protection/face protection
(P280). IF ON SKIN: Wash with plenty of soap and water (P302+P352).
Dispose of contents according to national and local law (P501).
●
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.
●
The QuikRead go CRP+Hb kit is intended solely for use with the QuikRead go
instrument.
●
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 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.
●
Do not splash liquid into the measuring well of the instrument.
CRP+Hb
®
Symbol
Storage at 2...8 °C
Until the expiry date
of the reagent caps
Until the expiry date
of the prefilled cuvettes
6 months
2 hours
.
2
QuikRead go
CRP+Hb
®
Cat. no. 140068, 50 tests
2 x 25
2 x 25 x 1 ml
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 prefilled cuvettes
3 months
2 hours
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