Orion Diagnostica QuikRead go CRP User manual

146382-2
• English
• Español
QuikRead go®
CRP
Assay Procedure • Procedimiento del ensayo
1 2
3 4
5 6
7 8 Measure RESULT
Patient ID:
Test:
XXXXXXXX Measurement time:
CRP:
CRP
2013-06-11 12:19
mg/l
20
Exit Print New measurement
Result info
Choose Result info to view result information.
Remove cuvette to perform a new measurement.
i

QuikRead go®CRP
Cat. no. 145215
Rx only
1 Intended use
The QuikRead go®CRP test is an immunoturbidimetric assay for the in vitro
quantitative determination of C-reactive protein (CRP) in K2-EDTA and lithium heparin
whole blood, K2-EDTA and lithium heparin plasma, and in serum samples. The test is
carried out by means of the QuikRead go instrument.
Measurement of C-reactive protein aids in the evaluation of injury to body tissues,
and infection and inammatory disorders. The instrument and assay are for use by
trained professionals in the clinical laboratory. For in vitro diagnostic use only. Not for
point-of-care use.
2 Summary and explanation of the test
Infections, tissue injuries, and inammatory disorders may be accompanied by a non
specic elevation of the CRP level in the patient’s blood. The rise in CRP levels is
rapid, and increased levels can be detected within 6–12 hours of the onset of the
inammatory process.1 In acute inammatory processes the CRP levels can reach
approximately 20‒500 mg/L.3,4
Quantitative measurement of CRP concentration has been reported to be a sensitive
indicator of the efcacy of antimicrobial therapy and the course of bacterial infections,
as well as an effective tool in controlling and monitoring postoperative infections.1, 4−7
The advantages of measuring CRP lie in it being a sensitive, early, and reliable
reector of the acute-phase response. It can also be used for accurate monitoring
of the patient’s condition and response to therapy. However, the rise in CRP level is
non-specic.
3 Principles of the procedure
QuikRead go CRP is an immunoturbidimetric test based on the agglutination
reaction. Microparticles are coated with anti-human CRP F(ab)2fragments, and
the CRP present in the sample reacts with the microparticles. The resultant change
in the turbidity of the solution is measured by the QuikRead go instrument.
The sample is added to the buffer in prelled cuvettes, and the blood cells in a whole
blood sample are hemolyzed. The calibration data of the test are found in the barcode
label of the cuvette, which the QuikRead go unit reads automatically before the start
of the test. For whole blood sample, the CRP value is automatically corrected on the
basis of the sample’s hematocrit level. Hematocrit results are not displayed but are
used in the calculations. The CRP measurement range of the assay is 5‒150 mg/L
with whole blood samples and 5‒120 mg/L with serum or plasma samples.
4 Reagents
QuikRead go CRP Cat. no. 145215
Component
name and
origin
Symbol
Stability
Opened
at 2…8 °C
(36…46 °F)
Opened at
18…25 °C
(64…77 °F)
Unopened
at 2…8 °C
(36…46 °F)
Unopened
at 18…25 °C
(64…77 °F)
CRP
Reagent
Caps 50
Until the
expiration
date marked
on the label
24 h/day
for 1 month,
7.5 h day
for 3 months
Until the
expiration
date marked
on the label
24 h/day
for 1 month,
7.5 h/day for
3 months
Buffer
50 x 1 mL
Foil pouch:
6 months Foil pouch: 3 months
Until the
expiration
date marked
on the label
Until the
expiration
date marked
on the label
Single
prelled
cuvette:
2 hours
Single
prelled
cuvette:
2 hours
‒ ‒
Capillaries
(20 µL) 50 ‒ ‒ ‒ ‒
Plungers 50 ‒ ‒ ‒ ‒
The reagents contain sodium azide as a preservative; please see Section 5,
“Warnings and precautions.”
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.
English
50

5 Warnings and precautions
Health and safety information
● Caution: Federal Law restricts this device to sale by or on the order of a licensed
practitioner.
● For in vitro diagnostic use only.
● For prescription only.
● For professional use only.
● Do not smoke, eat, or drink on premises where samples or kit reagents are
handled. Wear suitable personal protective clothing and disposable gloves when
handling patient samples and kit reagents. Wash your hands thoroughly when
nished performing the test.
● Avoid contact with the skin and eyes. After skin contact, wash immediately with
plenty of water.
● All patient samples and controls should be handled as potentially infectious
material.
● The lyophilized reagent contains <1% sodium azide (Aquatic Chronic 3). Harmful
to aquatic life with long-lasting effects (H412). Avoid release to the environment
(P273). Dispose of contents in accordance with national and local law (P501).
The 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 buildup can be avoided via ushing with a large volume of
water when one is disposing of the reagents.
● For disposal considerations, see Section 15.
Analytical precautions
● Do not use the product after the expiration date marked on the outer package.
● Do not exceed the stated stability periods for opened reagents.
● The QuikRead go CRP kit is intended solely for use with the QuikRead go
instrument.
● Do not mix components from different lot numbers. The components are disposable;
never reuse components already used for performing a test.
● When opening a kit for the rst 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 an individual cuvette
that its foil covering is intact.
● Do not touch the clear at surfaces of the lower part of the cuvette (the optical
part). Discard any cuvettes with ngerprints.
● Keep the CRP Reagent Caps away from moisture. Close the aluminum tube
immediately after taking out the required number of reagent caps.
● Do not splash liquid into the measuring well of the instrument.
6 Sample collection and preparation
Sample material, collection and volume
Use of capillaries and plungers
The QuikRead go CRP kit contains pre-measured 20 μL
capillaries and plungers. The plunger is inserted on the
blue stripe end. The capillary is then lled up to the white
stopper. Take care to ensure that there is no air in the
capillary and that the capillary is lled all the way to the
white stopper. Use a soft tissue to wipe away any residual
sample from the outside of the capillary. Make sure the soft
tissue does not draw any sample from inside the capillary.
Sample
material
Sample
collection
Anticoagulated
whole blood
Use a venous blood sample collected in a tube containing
Li-heparin or K2-EDTA. Mix whole blood by inverting the
tube several times, and take 20 μL with a capillary. Only the
capillaries included in the kit are recommended for adding
of the sample.
Plasma
Use K2-EDTA/Li-heparin plasma. Avoid clearly hemolyzed
samples. Mild hemolysis will not affect the test results. Only
the capillaries included in the kit are recommended for add-
ing of the sample.
Serum
Avoid clearly hemolyzed samples. Mild hemolysis will not
affect the test results. Only the capillaries included in the kit
are recommended for adding of the sample.
Sample dilution
Sample type Instructions
Whole blood Do not dilute whole blood samples.
Plasma/serum
Plasma or serum samples may be diluted with a 0.9% NaCl
solution before the sample is added to the cuvette.
The recommended dilution ratio is 1+3 (by volume, 1 part
sample + 3 parts 0.9% NaCl). Take 20 μL of the diluted
sample into a cuvette, analyze the sample, and multiply the
obtained result by 4.
Sample storage
Sample material Storage
Anticoagulated whole blood
(K2-EDTA and Li-heparin) 2...8 °C (36…46 °F) for 3 days
Plasma (K2-EDTA and Li-heparin) 2...8 °C (36…46 °F) for 7 days
Serum 2...8 °C (36…46 °F) for 7 days
Sample (K2-EDTA and
Li-heparin whole blood, K2-EDTA and
Li-heparin plasma, serum) in buffer
18…25 °C (64…77 °F) for 2 hours
Allow the samples to reach room temperature (18...25 °C, 64…77 °F) before testing.

7 Procedure
Materials required but not provided
The following materials are required to perform the test but are not provided.
The materials provided are listed in Section 4. “Reagents”.
Material Cat. No Remarks
QuikRead go®instrument with
software version 6.3.6 or newer 145218 ‒
QuikRead go®CRP Control Set 145217 Recommended for
quality control
QuikRead go® CRP Verication Set 145216 Recommended for
calibration verication
Assay procedure
Before starting an assay, read and follow the QuikRead go instrument and QuikRead
go CRP test instructions for use. Note that marketing materials that may be enclosed
(including multimedia presentations) do not replace the written instructions for
use; they merely provide an additional tool contributing to the understanding of the
QuikRead concept.
Open the foil pouch of the cuvette rack, and mark the opening date on the cuvette rack.
Sample collection (see gures 1–5)
Only the capillaries (20 μL, cat. no. 132153) and plungers (cat. no. 67966) included in
the QuikRead go CRP kit (cat. no. 145215) are recommended for adding the sample
to a prelled cuvette.
1. A prelled cuvette must reach room temperature (18...25 °C, 64…77 °F) before
use. This takes 15 minutes for an individual refrigerated (2...8 °C, 36…46 °F)
prelled cuvette. Do not touch the clear at surfaces of the lower part of the cuvette
(the optical part). Remove the foil cover from the cuvette. Beware of splashing the
liquid. Condensed buffer on the foil cover has no effect on the results. The test
must be performed within two (2) hours from opening of the cuvette.
2. Insert the plunger into the capillary at the end with the blue stripe.
3. Fill the capillary with the sample (20 µL), up to the white stopper. Ensure that there
are no air bubbles in the capillary. Use a soft cloth or tissue to wipe any residual
sample from the outside of the capillary.
4. Place the sample capillary into the buffer solution in the cuvette, and dispense by
pressing down the plunger. Make sure that the capillary is completely empty.
5. Close the cuvette tightly with a CRP Reagent Cap. Do not press down the blue
inner part of the cap. After the sample has been added to the buffer, the solution
is stable for two (2) hours. Keep the cuvette upright, and do not shake.
Analyzing the sample (see gures 6–8)
Begin the test by turning on the instrument. For full instructions, see the QuikRead go
instrument’s instructions for use. The display will guide you through the test.
6. Select Measure on the display of the QuikRead go instrument.
7. Place the cuvette in the instrument, with the barcode facing you, as shown in
Figure 7. The instrument detects the sample type. The display shows how the
measurement is progressing.
8. The result appears on the display when the measurement is completed, and the
cuvette automatically rises from the measurement well.
Analyzing the control
Please see the instructions for use provided with the QuikRead go CRP Control Set
(cat. no. 145217). Analyze the control samples as patient samples, but select Quality
Control on the display of the QuikRead go instrument. The result will be stored as a
control measurement.
8 Quality control
External controls may be used to verify that the reagents and procedures are
performing properly. Use of QC materials is recommended for each day of testing, in
accordance with federal, state, and/or local regulations or accreditation requirements.
The QuikRead go CRP Control set is recommended to be used with the QuikRead
go CRP test.
QuikRead go CRP Control Set (cat. no. 145217):
The QuikRead go CRP Control Set contains two ready-to-use controls, with different
levels of CRP. Perform the test as outlined in Section 7. “Procedure”. The sample
volume is 20 µL. The 20 µL capillaries are recommended for adding of the sample.
The QuikRead go CRP tests are factory-calibrated. The QuikRead go CRP Verication
Set (cat. no. 145216) should be used for verication of the calibration in line with
CLIA regulations. Please consult Section 16. “Troubleshooting” and contact Orion
Diagnostica or your local distributor if you observe any changes in test functionality.
Other commercially available controls:
Handle and use the controls in accordance with the instructions for each control
substance. Acceptable limits for the control must be determined with precision results
gained with the QuikRead go instrument. The blanking process might not succeed
if you use a control that contains articial red blood cells, because these might not
hemolyze normally.
9 Results’ interpretation
After the sample has been successfully analyzed, the CRP results are presented on
the screen of the QuikRead go instrument. If necessary, please consult Section 16.
”Troubleshooting”, and repeat the test.
The rise in CRP level is non-specic and should not be interpreted without a complete
clinical history. Serial CRP measurements may be required in monitoring of patient
condition or response to therapy.
Test values are considered to be clinically signicant at levels above 10 mg/L (cutoff
value) 2, 9, 10.
If diluted plasma or serum samples have been used, the nal results need to be
calculated in accordance with the instructions in Section 6. “Sample Collection and
Preparation”.

10 Limitations of the procedure
Assay procedures other than those specied in these instructions may yield
questionable results. Some substances may interfere with the test results; please
see Section 12. “Performance Characteristics”.
CRP results should never be used alone, without a complete clinical evaluation. Intra-
individual variations in CRP are signicant and should be taken into account – e.g., by
means of serial measurements – in interpretation of the values.
The QuikRead go CRP test is not intended for use as high sensitivity CRP or cardiac
CRP.
11 Expected values
The assay reference range limit was determined by using 143 apparently healthy
adults (59 males and 84 females) with age 19-65 according to CLSI EP28-A3C
guideline. Based on the results the 95 % reference limit was concluded to be ≤ 5 mg/L
for each sample type. Results are based on a non parametric approach.
However, each laboratory is recommended to establish a range of normal values for
their population in their region.
12 Performance characteristics
Precision
A precision study was performed in line with Clinical and Laboratory Standards
Institute (CLSI) guidelines, EP05-A3.
Within-run, between-day, and total precision
Sample
material
Sample
number
Number
of days
Mean CRP
(mg/L)
Within-run
CV (%)
Between-day
CV (%)
Total
CV (%)
Li-heparin
whole blood
Sample 1
Sample 2
Sample 3
Sample 4
20
20
20
20
11
21
47
146
6.7
4.0
2.5
2.5
2.2
2.3
2.9
1.8
8.2
4.7
3.9
3.3
K2-EDTA
whole blood
Sample 1
Sample 2
Sample 3
Sample 4
20
20
20
20
8
23
53
131
7.7
3.4
1.3
1.7
2.2
2.3
2.9
1.9
9.2
6.1
2.6
2.6
Li-heparin
plasma
Sample 1
Sample 2
Sample 3
Sample 4
20
20
20
20
9
20
43
104
4.9
2.8
2.2
1.8
2.7
2.3
1.7
0.0
5.6
3.9
2.8
2.2
K2-EDTA
plasma
Sample 1
Sample 2
Sample 3
Sample 4
20
20
20
20
10
19
51
107
2.8
1.7
0.8
1.5
1.2
1.3
0.5
1.2
3.4
2.6
1.4
2.0
Serum
Sample 1
Sample 2
Sample 3
Sample 4
20
20
20
20
9
21
51
95
4.0
2.9
1.0
2.0
3.0
1.4
0.1
2.3
5.0
3.2
1.5
3.2
Control 1 Sample 1 20 25 2.7 2.1 3.4
Control 2 Sample 1 20 76 1.0 0.9 1.3
Interference
Interferent No interference found
up to concentration
Bilirubin
Vitamin C
Triglycerides
Rheumatoid factors (RF)
Anticoagulants (Li-heparin or EDTA)
Hemoglobin (plasma and serum)
230 mg/L
35 mg/L
10 g/L
525 IU/mL
No interference
20 g/L
Most heterophilic or anti-sheep antibodies in the samples do not interfere with the
test, because the assay antibodies lack the Fc part. In rare cases, interference by IgM
myeloma protein has been observed.
Limits of detection and quantitation
The assay limit of detection is 1.9 mg/L.
The assay limit of quantitation is 3.6 mg/L.
The lower limit of measuring range is 5 mg/L.
Measurement range
Plasma and serum samples
The QuikRead go CRP test is linear with plasma and serum samples within the
measurement range of 5−120 mg/L. When the CRP result is outside the measurement
range, the result will be displayed as “CRP < 5 mg/L” or “CRP > 120 mg/L”.
Whole blood samples
The QuikRead go CRP test is linear with whole blood samples (with hematocrit values
between 15−75%) within the measurement range of 5−150 mg/L. When the CRP
result is outside this measurement range, the result will be displayed as “CRP < 5
mg/L” or “CRP > 150 mg/L”. The CRP result is not displayed if the level of hematocrit
is outside the range 15−75%.
Prozone
CRP concentrations of less than 1000 mg/L do not give falsely low results.

13 Traceability
The calibrators used to calibrate the QuikRead go CRP test are traceable to the
ERM®-DA474 reference material.
14 Method comparison
Method comparison studies were performed with all sample matrices. The QuikRead
go CRP test was compared against two clinical laboratory methods. The performance
characteristics are in the table below:
Sample type Clinical laboratory
method
Number of
samples
Intercept Slope R
K2-EDTA
whole blood
ABX CRP REA 68 -2.98 0.90 0.992
K2-EDTA
plasma
Tina-Quant
C-reactive protein
Gen 3.
62 -0.24 1.01 0.998
Li-heparin
plasma
Tina-Quant
C-reactive protein
Gen 3.
62 -0.12 0.95 0.998
Serum Tina-Quant
C-reactive protein
Gen 3.
62 -0.34 0.95 0.997
Whole blood versus plasma comparability
In a comparison of 62 patient samples, K2-EDTA whole blood (y) and respective K2-
EDTA plasma (x) yielded comparable results: y = 0.96x – 1.24
15 Disposal
● Dispose of contents in accordance with federal, state, and local requirements.
● All patient samples and used cuvettes should be handled and disposed of as
biohazardous waste and discarded in a container designated as for hazardous
biowaste. Discard lancets and capillaries in a sharps container labeled with the
biohazard symbol.
● Materials used in the components
- Paper: Instructions for use
- Cardboard: Kit box
- Plastic: Cuvettes, reagent caps, foil covering cuvette rack, cuvette rack,
plungers, plunger and capillary tubes
- Glass: Mylar coated capillaries
- Metal: Reagent cap tubes, cuvette lids, plunger and capillary tube caps
- Several (not to be recycled): Lids of reagent cap tubes
● When used in accordance with Good Laboratory Practice, good occupational
hygiene, and the instructions for use, the reagents supplied should not present a
health hazard.
16 Troubleshooting
Error messages
Error messages displayed by the QuikRead go instrument are listed below. For
more detailed information on error messages, consult the QuikRead go instrument
instructions for use.
Error messages Corrective actions
Cuvette position not
correct. Remove cuvette.
Remove the cuvette and reinsert it,
in the right position.
Measurement prohibited.
Please check the reagent
cap.
Check that the cuvette has a reagent cap and the
inner blue part of the cap is not pressed down.
Measurement prohibited.
Kit lot expired. Discard the expired kit lot. Use a new one.
Measurement prohibited.
Cuvette temperature
too low.
Let the cuvette warm up to room temperature
(18...25 °C, 64…77 °F). Test the same cuvette again.
Measurement prohibited.
Cuvette temperature too
high.
Let the cuvette cool to room temperature
(18...25 °C, 64…77 °F). Test the same cuvette again.
Test cancelled.
Blank too high. Test the same cuvette again. The blanking process
has not been completed, or the sample may contain
interfering substances. In the latter case, the test
cannot be completed.
Test cancelled.
Unstable blank.
Test cancelled.
Error in reagent addition.
Perform a new test. There has been a problem during
reagent addition. Make sure that the cap is properly
closed.
Test cancelled.
Instrument failure.
Perform a new test. If this message appears often,
contact your local distributor or call Customer Service.
No result.
Unable to do
hematocrit correction.
Test the same cuvette again. If the error message
appears again, perform a new test. If the test cannot
be completed at all, the sample may contain interfering
substances or be otherwise compromised.
No result.
Hematocrit too low.
If the level of hematocrit in a whole blood sample
is below the hematocrit measurement range of the
instrument (see Section 12.), no result is shown.
No result.
Hematocrit too high.
If the level of hematocrit in whole blood samples is
above the hematocrit measurement range of the
instrument (see Section 12.), no result is shown.
Error code xx.
Please restart
the instrument.
Restart the instrument. If the error message appears
again, contact your local distributor or call Customer
Service and give the error code.
Error code xx.
Please call customer
service.
Contact your local distributor or call Customer Service,
reporting the error code.

Printed 9/2017
Orion Diagnostica Oy
Koivu-Mankkaan tie 6 B
P.O.Box 83, FI-02101 Espoo, Finland
Tel. [phone]
Fax [phone]
www.oriondiagnostica.com
www.quikread.com
References ● Referencias
1. van Leeuwen MA & van Rijswijk MH. Acute phase proteins in the monitoring of inammatory
disorders. Baillieres Clin Rheumatol. 1994; 8 (3): 531–52.
2. Weitkamp JH and Aschner JL. Diagnostic use of C-reactive protin (CRP) in Assessment of
Neonatal Sepsis. Neoreviews 2005;6(11): 508-15.
3. Hind CRH, Pepys MB. The role of C-reactive protein (CRP) measurement in clinical
practice. Int. Med 1984;5: 112-151.
4. Olaison L et al. Fever C-reactive protein and other acute-phase reactants during treatment
of infective endocarditis. Arch Intern Med. 1997; 157 (8): 885–92.
5. Peltola H et al. Simplied treatment of acute staphylococcal osteomyelitis of childhood.
Pediatrics.1997; 99 (6): 846–50.
6. Philip AGS & Mills PC. Use of C-reactive protein in minimizing antibiotic exposure: Experience
with infants initially admitted to a well-baby nursery. Pediatrics. 2000; 106 (1): 1–5.
7. Pepys MB. The acute phase response and C-reactive protein. In: Warrell DA, Cox TM, Firth JD,
Benz EJ, (eds). Oxford Textbook of Medicine, 4th ed. Oxford University Press, 2003; 2: 150–6.
8. Guidance for Industry and FDA staff: Review Criteria for Assessment of C-reactive Protein
(CRP), High Sensitivity C-Reactive Protein (hsCRP) and Cardiac C-Reactive Protein
(cCRP) assays. Document issued on September 22, 2005.
9. Myers et al. CDC/AHA Workshop on Markers of Inammation and Cardiovascular
Disease: Application to Clinical and Public Health Practice: laboratory tests available to
assess inammation--performance and standardization: a background paper. Circulation
2004;110(25): 545-549.
Explanation of symbols ● Explicación de los símbolos
English Español
In vitro diagnostic
medical device
Producto sanitario para
diagnóstico in vitro
Catalogue number Número de catálogo
Batch code Código de lote
Use by Fecha de caducidad
Temperature limitation Limitación de temperatura
Consult instructions for use Consúltense las
instrucciones de uso
Manufacturer Fabricante
Sufcient for Válido para
Reagent caps Tapones de reactivo
Buffer Tampón
Capillaries Capilares
Plungers Embolos
Origin: sheep Origen: oveja
Contains sodium azide Contiene azida sódica
Rx only For prescription only Solamente para uso
con receta
QuikRead go®is a registered trademark of Orion Diagnostica Oy.
QuikRead go®es una marca registrada de Orion Diagnostica Oy.

146382-2
• English
• Español
QuikRead go®
CRP
Assay Procedure • Procedimiento del ensayo
1 2
3 4
5 6
7 8 Measure RESULT
Patient ID:
Test:
XXXXXXXX Measurement time:
CRP:
CRP
2013-06-11 12:19
mg/l
20
Exit Print New measurement
Result info
Choose Result info to view result information.
Remove cuvette to perform a new measurement.
i

QuikRead go®CRP
Cat. no. 145215
Rx only
1 Uso recomendado
El test de PCR QuikRead go®es una prueba inmunoturbidimétrica para la
determinación cuantitativa in vitro de los valores de proteína C reactiva (PCR)
en sangre entera con EDTA K2y con heparina de litio; en plasma con EDTA K2y
con heparina de litio y en muestras de suero. La prueba se realiza con el equipo
QuikRead go.
La lectura de la proteína C reactiva ayuda a evaluar las lesiones de tejidos corporales
y los trastornos infecciosos e inamatorios. El uso del instrumento y la realización
de la prueba deben ser ejecutados por profesionales capacitados en el laboratorio
clínico. Solo para uso diagnóstico in vitro. No para uso en punto de antención.
2Resumen y explicación del test
Las infecciones, las lesiones de tejidos, y los trastornos inamatorios pueden ir
acompañados de una elevación no especíca del nivel de PCR en la sangre del
paciente. El aumento de los niveles de PCR es rápido, y estos niveles aumentados
se pueden detectar dentro de 6–12 horas siguientes al inicio del proceso
inamatorio.1 En procesos inamatorios agudos, los niveles de PCR pueden llegar a
aproximadamente 20–500 mg/l.2, 3
La medición cuantitativa de la concentración de PCR se ha reportado como
un indicador sensible de la ecacia de la terapia antimicrobiana y el curso de
las infecciones bacterianas, así como una herramienta ecaz para el control y
seguimiento de las infecciones postoperatorias.2,5-8
Las ventajas de la lectura de la PCR se enmarcan en que la PCR es un reejo
sensible, temprano y conable de la respuesta de fase aguda. También se puede
utilizar para un monitoreo preciso de la condición y respuesta al tratamiento del
paciente. Sin embargo, el aumento en el nivel de la PCR es inespecíco.
3 Principios del procedimiento
QuikRead go para PCR es un test inmunoturbidimétrico basado en la reacción de
aglutinación. Las micropartículas se recubren con fragmentos de la F(ab)2anti PCR
humana, y la PCR presente en la muestra reacciona con las micropartículas. El
cambio resultante en la turbidez de la solución se mide con el equipo QuikRead go.
La muestra se añade al buffer en cubetas prellenadas, y las células sanguíneas
de la muestra de sangre entera se hemolizan. Los datos de calibración del test se
encuentran en la etiqueta de código de barras de la cubeta; la unidad de QuikRead go
la lee automáticamente antes de comenzar el test. Para muestra de sangre entera, el
valor de la PCR se corrige automáticamente con base en el nivel de hematocrito de
la muestra. Los resultados del hematocrito no se muestran, pero se utilizan en los
cálculos. El rango de lectura de la prueba de PCR es de 5–150 mg/L con muestras
de sangre entera y de 5–120 mg/L con muestras de suero o plasma.
4 Reactivo
QuikRead go CRP Cat. no. 145215
Nombre y
origen del
compo-
nente
Símbolo
Estabilidad
Abierto
a 2…8 °C
(36…46 °F)
Abierto
a 18…25 °C
(64…77 °F)
Sin abrir
a 2-8 °C
(36-46 °F)
Sin abrir
a 18-25 °C
(64-77 °F)
Tapa del
reactivo PCR 50
Hasta la
fecha de
expiración
indicada en
la etiqueta
24 h/día
durante
1 mes,
7.5 h/día
durante
3 meses
Hasta la
fecha de
expiración
indicada en
la etiqueta
24 h/día
durante
1 mes,
7.5 h/día
durante
3 meses
Buffer
50 x 1 mL
Bolsa
metálica:
6 meses
Bolsa
metálica:
3 meses
Hasta la
fecha de
expiración
indicada en
la etiqueta
Hasta la
fecha de
expiración
indicada en
la etiqueta
Cubeta
precargada
sencilla:
2 horas
Cubeta
precargada
sencilla:
2 horas
‒ ‒
Capilares
(20 µL) 50 ‒‒ ‒ ‒
Émbolos 50 ‒ ‒ ‒ ‒
Los reactivos contienen azida sódica como preservante; por favor consulte la
Sección 5, “Advertencias y precauciones”.
Condiciones de preparación y almacenamiento de reactivos
Todos los reactivos están listos para usarse.
Mantenga las tapas del Reactivo para PCR alejados de la humedad. Cierre el tubo de
aluminio inmediatamente después de sacar el número requerido de tapas de reactivo.
Deterioro de los reactivos
El producto debe utilizarse solo si el volumen del buffer en la cubeta es correcto.
Compruebe que la supercie del líquido se encuentra entre las dos líneas marcadas
en la cubeta. No utilice una cubeta con suciedad visible en el buffer.
50
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5 Advertencias y precauciones:
Información de salud y seguridad
● Precaución: La ley federal restringe la venta de este dispositivo, que solo puede
realizarse por medio de un profesional legalmente autorizado o bajo sus órdenes.
● Para uso diagnóstico in vitro solamente.
● Solo para uso profesional.
● Solo para uso con receta.
● No fume, coma o beba en los locales donde se manipulen muestras o reactivos del
kit. Use indumentaria de protección personal adecuada y guantes desechables
al manipular las muestras de los pacientes y los reactivos del kit. Lávese bien las
manos cuando haya terminado de realizar el test.
● Evite el contacto con la piel y los ojos. En caso de contacto con la piel, lávese
inmediatamente con abundante agua.
● Todas las muestras de los pacientes y los controles deben manipularse como
material potencialmente infeccioso.
● El reactivo liolizado contiene <1% de azida sódica (Acuático crónico. 3). Nocivo
para los organismos acuáticos, con efectos nocivos duraderos (H412). Evitar su
liberación al medio ambiente (P273). Eliminar el contenido de acuerdo con la
legislación nacional y local (P501).
Los reactivos reconstituidos y líquidos contienen <0.1% de azida sódica, que no se
considera una concentración dañina. La azida sódica libera gases tóxicos en contacto
con los ácidos. Las azidas pueden reaccionar con las tuberías de metal, formando
compuestos explosivos. La acumulación de azidas puede evitarse mediante el
lavado con un gran volumen de agua cuando uno se deshace de los reactivos.
● Para consideraciones sobre eliminación, véase la Sección 15.
Precauciones analíticas
● No utilice el producto después de la fecha de expiración marcada en el empaque.
● No exceda los períodos de estabilidad indicados para los reactivos abiertos.
● El kit de PCR QuikRead go está destinado exclusivamente para su uso con el
equipo QuikRead go.
● No mezcle componentes de diferentes números de lote. Los componentes son
descartables; nunca reutilice los componentes si ya han sido empleados para
realizar un test.
● Al abrir un kit por primera vez, asegúrese de que las bolsas metálicas (2 uds.)
que protegen las cubetas estén intactas. Si la bolsa metálica está dañada, no
utilice las cubetas que están en su interior. Además, antes de utilizar una cubeta,
siempre debe asegurarse de que su cubierta de aluminio esté intacta.
● No toque las supercies planas claras de la parte inferior de la cubeta (la parte
óptica). Deseche cualquier cubeta que tenga huellas dactilares.
● Mantenga las tapas del Reactivo para PCR alejados de la humedad. Cierre el
tubo de aluminio inmediatamente después de sacar el número requerido de tapas
de reactivo.
● No derrame líquido en el pocillo de lectura del equipo.
6Recolección y preparación de la muestra
Recolección y volumen del material de muestra
Uso de los capilares y émbolos
El kit de PCR de QuikRead go contiene capilares
premedidos de 20 μL y émbolos. El émbolo se inserta
en el extremo de la franja azul. Luego el capilar se llena
hasta el tapón blanco. Tenga cuidado de asegurarse
de que no haya aire en el capilar y que el capilar esté
lleno hasta el tope del tapón blanco. Utilice un pañuelo
suave para limpiar cualquier residuo de la muestra del
exterior del capilar. Asegúrese de que el pañuelo suave
no extraiga nada de muestra del capilar.
Material de muestra Recolección de la muestra
Sangre entera
anti-coagulada
Utilice una muestra de sangre venosa recolectada en un
tubo que contiene Li-heparina o EDTA K2. Mezcle la sangre
entera dando vuelta el tubo varias veces y tome 20 μL con
un capilar. Solo se recomiendan los capilares incluidos en
el kit para agregar la muestra.
Plasma
Utilice plasma con EDTA K2/Li-heparina. Evite las muestras
claramente hemolizadas. Una hemólisis leve no afectará
los resultados del test. Solo se recomiendan los capilares
incluidos en el kit para agregar la muestra.
Suero
Evite las muestras claramente hemolizadas.
Una hemólisis leve no afectará los resultados del test.
Solo se recomiendan los capilares incluidos en el kit para
agregar la muestra.
Dilución de la muestra
Tipo de Muestra Instrucciones
Sangre entera No diluya las muestras de sangre entera.
Plasma/suero
Las muestras de suero o plasma pueden diluirse con una so-
lución de NaCl al 0.9% antes de añadir la muestra a la cubeta.
La relación de dilución recomendada es 1+3 (por volumen:
1 parte de muestra + 3 partes de NaCl al 0.9%).
Tome 20 μl de la muestra diluida en una cubeta, analice la
muestra y multiplique el resultado obtenido por 4.
Almacenamiento de la muestra
Material de muestra Almacenamiento
Sangre entera anticoagulada
(EDTA K2 y Li-heparina) 2–8 °C (36–46 °F) por 3 días
Plasma (EDTA K2 y Li-heparina) 2–8 °C (36–46 °F) por 7 días
Suero 2–8 °C (36–46 °F) por 7 días
Muestra (sangre entera con EDTA K2
y Li-heparina, plasma con EDTA K2
y Li-heparina, suero) en buffer
18–25 °C (64–77 °F) por 2 horas
Permita que las muestras alcancen la temperatura ambiente (18–25 °C, 64–77 °F)
antes del test.