cobas CRP Test

REF 08024669119 10
English
Intended use
The Roche cobas b 101 is an in vitro diagnostic test system designed to
quantitatively determine the C‑reactive protein (CRP) in human capillary
whole blood and serum, EDTA K2/K3 and lithium heparin anticoagulated
whole blood and plasma by photometric measurement. Measurement of
CRP is of use for the evaluation of inflammatory disorders and associated
diseases, infection and tissue injury. The system is intended for use in
point‑of‑care (PoC) settings such as pharmacies, physician offices,
physician office laboratories, clinics and hospitals, and clinical laboratory
settings.
Note: Please note that the catalogue number appearing on the package insert
retains only the first 8 digits of the licensed 11-digit catalogue number:
08024669190 for the cobas CRP test. The last 3 digits -190 have been replaced
by 119 for logistic purposes.
Summary
Most tissue‑damaging processes such as infections, inflammatory diseases
and malignant neoplasms are associated with a major acute phase
response of the C‑reactive protein (CRP) and other acute phase reactants
(e.g. AAT, AAGP, C3C, C4, HAPT). The CRP response frequently precedes Sample stability on disc
clinical symptoms, including fever. In healthy individuals CRP is a trace i After sample application, the disc must be inserted immediately (in
protein with a range up to 5 mg/L. After onset of an acute phase response ≤ 120 seconds). Please follow the instructions in the cobas b 101
the serum CRP concentration rises rapidly and extensively. Alterations are Operator’s Manual.
detectable within 6 to 8 hours and the peak value is reached within 24 to
48 hours. Levels of up to a thousandfold the normal value are associated Assay
with severe stimuli such as myocardial infarction, major trauma, surgery, or Instructions for use
malignant neoplasms. CRP activates the classical complement pathway.
CRP has a half‑life of only a few hours, making it an ideal tool for clinical ▪ Wash hands with soap. Warm water helps to stimulate the blood flow.
monitoring. Postoperative monitoring of CRP levels of patients indicates Rinse the fingers extensively. Dry hands.
either the normal recovery process (decreasing levels to normal) or ▪ Disinfect the fingertip by wiping three times the area to be lanced with a
unexpected complications (persisting high levels). Measuring changes in the cotton swab or sterile gauze pad impregnated with 70 %‑100 %
concentration of CRP provide useful diagnostic information about how acute isopropanol emollient free or 70 %‑100 % ethanol emollient free; repeat
and how serious a disease is. It also allows the assessment of complications the procedure with a second cotton swab or sterile gauze pad
during the disease and judgements about the disease genesis. Persistence impregnated with 70 %‑100 % isopropanol emollient free or
of a high CRP concentration is usually a grave prognostic sign which 70 %‑100 %ethanol emollient free, then dry with a cotton swab or sterile
generally indicates the presence of an uncontrolled infection. CRP gauze pad.
determination may replace the classical determination of Erythrocytes
Sedimentation Rate (ESR), due to its prompt response to changes in ▪ Prick the patient’s finger by applying a single‑use disposable lancing
disease activity and its good correlation to ESR.1,2,3,4 device (e.g. Accu‑Chek Safe‑T‑Pro Plus). Make sure to follow the
lancing device instructions for obtaining a blood sample.
Test principle
▪ Wipe off the first drop of blood with a swab.
The erythrocytes of the capillary or venous blood sample are separated from
the plasma by centrifugation. Then, the plasma sample is diluted with ▪ With the imprinted side of the disc facing upwards, position the disc’s
HEPES buffer and transferred into a reaction chamber where it is mixed with suction point above the drop of blood. The disc is self-filling.
CRP antibody‑latex reagent. The CRP in the diluted plasma binds with the ▪ Apply blood and observe that it has filled the marked area. Check the
CRP antibody on the latex particle. The concentration of CRP is calculated sample volume: turn the disc on its backside. The area marked in blue
as a function of the changed absorbance measured at 525 nm and 625 nm has to be filled completely with blood. Do not push the blood into the
which is in relation to the amount of agglutination.5,6,7 disc.
Reagents ▪ Press hinge cover down firmly to close the disc.
One test contains: ▪ Assure that the disc is free from blood outside the sample application
HEPES buffer: 1.79 mg zone and the hinge cover.
Anti‑human CRP antibody (goat) Latex‑conjugate: 41.84 µg ▪ Insert the disc into the cobas b 101 instrument. Close the lid.
Precautions and warnings ▪ The measurement starts automatically.
For in vitro diagnostic use. For more details, please refer to the cobas b 101 Quick Reference Guide
Exercise the normal precautions required for handling all laboratory or cobas b 101 Operator's Manual.
reagents.
Disposal of all waste material should be in accordance with local guidelines.
Safety data sheet available for professional user on request.
Reagent handling
Carefully tear open the foil pouch at the tear notch until one side is open.
Discard the disc if the foil pouch is found open or damaged, or if the disc is
damaged, or the desiccant is missing, or loose desiccant particles or any
other dirt or particles especially at the blood application zone are found.
Use cobas CRP Control in the same way as a blood sample.
Storage and stability
Store at 2‑30 °C until the expiration date printed on the pouch. Do not
freeze. If stored in a refrigerator, allow the disc to warm up in the closed
pouch for at least 20 minutes before use. Once the pouch is opened, use
the disc within 20 minutes. Protect the disc from direct sunlight. Do not store
opened pouches in a refrigerator.

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cobas CRP Test
Calibration measurements per run and specimen. The following results were obtained
This method has been standardized against the ERM DA 472/IFCC for a representative lot:
reference material. Each disc lot of the cobas CRP Test is traceable to
ERM DA 472/IFCC reference material.8,9 Repeatability Intermediate precision
The instrument automatically reads in the lot-specific calibration data from Mean SD CV Mean SD CV
the barcode information printed on the disc, eliminating the need for Sample mg/L mg/L % mg/L mg/L %
calibration by the user.
Sample Healthy 5.1 0.13 2.5 5.1 0.17 3.3
Quality control
Sample Cut off 10.0 0.23 2.3 10.0 0.24 2.4
For quality control, use cobas CRP Control.
The control intervals and limits should be adapted to each laboratory’s Sample Decision 39.9 0.93 2.3 39.9 0.98 2.5
individual requirements. Values obtained should fall within the defined limits. Sample Acute 93.4 1.62 1.7 93.4 1.84 2.0
Each laboratory should establish corrective measures to be taken if values
fall outside the defined limits. Sample Acute High 351 7.99 2.3 351 8.42 2.4
Follow the applicable government regulations and local guidelines for quality Control Level 1 9.7 0.29 2.9 9.7 0.30 3.1
control.
Control Level 2 39.2 0.79 2.0 39.2 1.09 2.8
QC info disc
Every cobas CRP Control kit contains a lot‑specific QC info disc for quality
control. This QC info disc contains the target values and ranges for the
cobas CRP Test.
The instrument display prompts the user to insert the QC info disc. The
cobas b 101 instrument reads the disc providing the lot specific target
ranges.
Display of results
At the end of the automatic determination, the cobas b 101 instrument
shows the result within 3‑4 minutes. The concentration of CRP will be
displayed in mg/L or in mg/dL.
Limitations - interference
Hematocrit levels between 20 % and 60 % do not affect results.
Criterion: Recovery within ± 10 % of initial values at CRP concentrations of
10.0 mg/L and 40.0 mg/L.
Hemolysis: No significant interference up to a hemoglobin concentration of
500 mg/dL.
Icterus:10 No significant interference up to a conjugated/unconjugated
bilirubin concentration of 50 mg/dL.
Lipemia (Intralipid):10 No significant interference up to an Intralipid and
Triglyceride concentration of 750 mg/dl.
Glycemia:10 No significant interference up to a glucose level of 1000 mg/dL.
A fasting sample is not required.
Rheumatoid factors: No significant interference up to 1200 IU/mL.
Drugs: No interference was found at therapeutic concentrations using
common drug panels.11
Drug interferences are measured based on recommendations given in CLSI
guidelines EP07 and EP37 and other published literature. Effects of
concentrations exceeding these recommendations have not been
characterized.
For diagnostic purposes, the results should always be assessed in
conjunction with the patient’s medical history, clinical examination and other
findings. C-Reactive Protein (CRP), High Sensitivity C-Reactive Protein (hsCRP)
and Cardiac C-Reactive Protein (cCRP) Assays; 2005, p. 1246.
Limits and ranges
Measuring range 2 Aguiar FJ, Ferreira-Júnior M, Sales MM, et al. C-reactive protein:
clinical applications and proposals for a rational use. Rev Assoc Med
3.0‑400 mg/L or 0.30‑40.0 mg/dL Bras Jan-Feb 2013, Vol. 59, pp. 85-92.
Expected values 3 van Leeuwen MA and van Rijswijk MH. Acute phase proteins in the
Adults: < 5.0 mg/L (< 0.5 mg/dL)2,12 monitoring of inflammatory disorders. Baillieres Clin Rheumatol., 1994,
Each laboratory should investigate the transferability of the expected values Vol. 8, pp. 531-52.
to its own patient population and if necessary determine its own reference 4 Gabay C. and Kushner I. Acute-Phase Proteins and Other Systemic
ranges. Responses to Inflammation. N Engl J Med, 1999, Vol. 340, pp.
448-454.
Specific performance data
Representative performance data on the instruments are given below. 5 Senju O, Takagi Y, Uzawa R, et al. A new immuno quantitative method
Results obtained in individual laboratories may differ. by latex agglutination-application for the determination of serum C-
reactive protein (CRP) and its clinical significance. J Clin Lab Immunol.,
Precision 1986, Vol. 19, pp. 99-103.
Precision was determined using controls in a CLSI EP5‑A3 protocol.
Precision was measured with 3 lots of cobas CRP Test using 5 different
serum samples at the medical decision points and 2 cobas CRP Control
solution levels over 21 days with 2 runs per day and duplicate

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cobas CRP Test

14 Johnson R. Assessment of Bias with Emphasis on Method

Comparison. Clin Biochem Rev 2008; Vol. 29, pp. S37-S42.
For further information, please refer to the appropriate Operator’s Manual
for the instrument concerned, and the Method Sheets of all necessary
components.
A point (period/stop) is always used in this Method Sheet as the decimal
separator to mark the border between the integral and the fractional parts of
a decimal numeral. Separators for thousands are not used.
Symbols
Roche Diagnostics uses the following symbols and signs in addition to
those listed in the ISO 15223‑1 standard (for USA: see dialog.roche.com for
definition of symbols used):
Contents of kit
Analyzers/Instruments on which reagents can be used
Reagent
Calibrator
Volume after reconstitution or mixing
GTIN Global Trade Item Number

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Additions, deletions or changes are indicated by a change bar in the margin.
© 2019, Roche Diagnostics

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