QuikRead go CRP for the USA

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

Speed

• Test time is two minutes
• Supports STAT sample analysis

Flexibility

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

Reliability

• Substantially equivalent to two clinical chemistry analyzers

Ease of 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 and limitations of the procedure

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

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 14521, 50 x 25 x 65 mm, 0.0347 kg

• QuikRead go CRP Verification Set 145216, 45 x 45 x 78 mm, 0.0491 kg

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.

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 (145217) is recommended to be used with the QuikRead go CRP test.

The QuikRead go CRP tests are factory-calibrated. The QuikRead go CRP Verification Set (145216) should be used for verification of the calibration in line with CLIA regulations.

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.

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.

Marketing and sales materials

For customers:

QuikRead go CRP Sales Sheet (US)

Instructions for use

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

QuikRead go CRP IFU (US, ES), 145215

QuikRead go CRP Control Set (US), 145217

QuikRead go CRP Verification Set (US), 145216

Safety Data Sheet

QuikRead go CRP SDS (US) 145215

QuikRead go CRP Control Set SDS (US) 145217

QuikRead go CRP Verification Set SDS (US) 145216

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 °C, 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 °C (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.