Description
In vitro diagnostic test system intended for the quantitative determination of C-reactive protein (CRP) in human whole blood and serum from capillary collection as well as in whole blood and plasma treated with the anticoagulants K2/K3-EDTA and lithium heparin by photometric measurement.
CRP measurement is useful for the evaluation of inflammatory states and the diseases, infections and tissue lesions associated with them.
The red blood cells in the capillary or venous blood sample are separated from the plasma by centrifugation. The plasma sample is then diluted with HEPES buffer and transferred to a reaction chamber, where it is mixed with anti-PCR antibody-latex reagent. The PCR present in the diluted plasma binds to the anti-PCR antibody on the latex particle.
The PCR concentration is calculated as a function of the changed absorbance measured at 525 nm and 625 nm, correlated with the amount of agglutination.
The system is intended for use in Point of Care (POC) locations, such as pharmacies, outpatient clinics, ambulatory laboratories, clinics and hospitals, as well as in clinical laboratories.

How to use
Use of reagents
Carefully tear the foil pouch at the appropriate notch until it is open on one side. Discard the disc if the foil pouch is already opened or damaged, if the disc is damaged, if the desiccant is missing or if loose desiccant particles or any other dirt or particles are found especially in the blood reaction zone.
Use the cobas CRP Control using the same procedure as for a blood sample.

Sample collection and preparation
Only use suitable test tubes or collection containers for collecting and preparing samples.
Use fresh human whole blood or serum from capillary collection, whole blood or plasma treated with the anticoagulants K2/K3-EDTA or lithium heparin. Do not use other anticoagulants or other additives.

For whole blood and plasma samples treated with the anticoagulants K2/K3-EDTA and lithium heparin, perform the test within 8 hours of sample collection if stored at room temperature.
If stored in the refrigerator, plasma samples can be used for up to 14 days and whole blood samples for up to 3 days.
Serum and plasma samples frozen and stored at -20°C can be used for up to 30 days.
Freeze only once.

Mix the sample thoroughly before use. Do not use frozen whole blood to avoid the risk of hemolysis.
The marking on the disc indicates where the sample should be applied. If samples were collected by venipuncture or from control material, use a standard pipette or a dropper pipette to create a drop.
The disc is self-filling.
Do not push the sample into the disc.
Do not use syringes.
Make sure there is no blood on the disc outside the sample reaction zone or on the outside of the hinged lid.

After sample application, the disc should be inserted immediately (within ≤120 seconds). Proceed according to the instructions in the cobas b 101 system user manual.

Execution
Wash your hands with soap. Warm water helps stimulate blood flow. Rinse your fingers thoroughly. Dry your hands thoroughly.
Disinfect the fingertip by wiping the area to be pricked 3 times with a sterile cotton or gauze swab soaked in 70-100% isopropanol, free of emollients, or 70-100% ethanol, free of emollients; repeat the procedure with a second sterile cotton or gauze swab soaked in 70-100% isopropanol, free of emollients, or 70-100% ethanol, free of emollients, then dry with a sterile cotton or gauze swab.
Prick the patient's finger using a disposable lancet (e.g. Accu-Chek Safe-T-Pro Plus). It is important to follow the instructions for the lancet to collect the blood sample. Wipe away the first drop of blood that comes out with a swab. With the printed side of the disc facing up, place the aspiration point of the disc over the drop of blood. The disc is self-filling. Apply blood and make sure the marked area is filled. To check the sample volume, turn the disc over. The area marked in blue should be completely filled with blood. Do not push blood into the disc.
Press down firmly on the hinged lid to close the disc. Make sure there is no blood on the disc outside the sample reaction zone or on the outside of the hinged lid.
Insert the disc into the cobas b 101 instrument. Close the lid. The measurement starts automatically.
After the automatic determination, the cobas b 101 instrument displays the result on the display within 3-4 minutes. The CRP concentration will be displayed in mg/L or mg/dL.

Warnings
For in vitro diagnostic use.
Observe the precautions normally taken when handling laboratory reagents.
All waste must be disposed of in accordance with local regulations.
Safety data sheet available on request for professional users.

Conservation
Store at 2-30°C until the expiration date printed on the pouch. Do not freeze. Do not expose the disc to direct sunlight.
If stored in the refrigerator, allow the disc to warm in the closed bag for at least 20 minutes before use. Once the bag is opened, use the disc within 20 minutes. Do not store opened bags in the refrigerator.
Validity with intact packaging: 4 months.

Format
Pack of 10 tests

Bibliography
1. 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; 2005, p. 1246.
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Cod. 8024669190