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QuikRead go CRP for the USA

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.

Generally

Measurement of C-reactive protein aids in the evaluation of injury to body tissues, and infection and inflammatory disorders. The instrument and assay are for use by trained professionals in the clinical laboratory. 

QuikRead go CRP provides you with

Fast

  • Test time is two minutes
  • Supports STAT sample analysis

Flexible

  • Minimum hands-on-time
  • Supports flexible processes in the laboratory

Reliable

  • Substantially equivalent to two clinical chemistry analyzers

Easy to use

  • Easy testing procedure and intuitive user interface
  • Maintenance-free instrument

Test results should never be used alone, without a complete clinical evaluation. For professional use. Not for point-of-care. Read more: QuikRead go CRP for the USA: Risks

Technical data

Products available
Use For in vitro diagnostic use
Method

Immunoturbidimetric

Sample type K2-EDTA whole blood and plasma, Li-heparin whole blood and plasma, serum
Instrument information

QuikRead go

Time to result 2 minutes
Reading of the result Instrument read
Storage 2 - 8 °C (36 - 46 °F)
Additionally needed

 

  • QuikRead go Instrument 145218
  • QuikRead go CRP Control Set 145217
  • QuikRead go Verification Set 145216

 

Registered trademark QuikRead go is a registered trademark of Orion Diagnostica Oy.

Test results should never be used alone, without a complete clinical evaluation. For professional use. Not for point-of-care.

C-reactive protein, CRP

Infections, tissue injuries, and inflammatory disorders may be accompanied by a non-specific 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 inflammatory process. (1) In acute inflammatory processes the CRP levels can reach approximately 20‒500 mg/L. (2, 3)

Quantitative measurement of 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.(1, 4−7) The advantages of measuring CRP lie in it being a sensitive, early, and reliable reflector 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-specific.

 

References

  1. van Leeuwen MA & van Rijswijk MH. Acute phase proteins in the monitoring of inflammatory 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. Simplified 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.

Risks and limitations of the procedure

Assay procedures other than those specified in these instructions may yield questionable results. Some substances may interfere with the test results; please see Section “Interference” below.

CRP results should never be used alone, without a complete clinical evaluation. Intraindividual variations in CRP are significant 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.

Interference

 

Interferent 

No interference foundup to concentration
Bilirubin 230 mg/L
Vitamin C 35 mg/L
Triglycerides 10 g/L
Rheumatoid factors (RF) 525 IU/mL
Anticoagulants (Li-heparin or EDTA) No interference
Hemoglobin (plasma and serum) 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.

Documents and materials

Marketing and sales materials

QuikRead go CRP Brief Instructions (US)

Instructions for use

(For informative use only. Kindly always refer to the latest package insert in the kit.)

QuikRead go CRP IFU (GB, ES), 145215

QuikRead go CRP Control Set (GB), 05968

QuikRead go CRP Verification Set (GB), 06116

Frequently asked questions

I accidentally left a QuikRead go CRP kit at room temperature for a weekend. Can I still use it?
Yes, you can use the kit. The kit can be stored at room temperature (18 - 25 ºC, 64-77 °F) for one month. If it is used at room temperature during daily working hours (7.5 hours) and stored at 2 - 8 ºC (36-46 °F) after finishing work, the kit will remain stable for 3 months.

The QuikRead go instrument gives me a result of > 150 mg/L, but I would like to get an exact CRP result. Is it possible?
When using plasma/serum samples you can dilute the sample with 0.9 % NaCl before adding it to the cuvette. The recommended dilution is 1+3. Remember to multiply the result by 4.

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