PreventID CRP 1/3. Additional information Manual Medical information Scientific background Questions & answers

Transcription

1 Additional information Manual Medical information Scientific background Questions & answers

2 Manual (for professional use) PreventID CRP 1/3 (KST02612) PreventID CRP 1/3 is a highly sensitive semi quantitative test used to detect CRP in whole blood. The sensitivity of the test is 1 mg/l CRP. Produced by hepatocytes, C-reactive protein (CRP) is a non-specific, acute-phase reactant indicating acute injury, bacterial infection and inflammation. Recent studies have found that CRP is also an indicator of myocardial infarction and that elevated levels of CRP are a good predictor of future cardiac diseases [1, 2, 3]. Although the detection of elevated levels of CRP in the serum is not specific for any particular disease, it is a useful indicator of inflammatory processes. CRP levels rise in blood within 24 to 48 hours following acute tissue damage, reach a peak during the acute stage and decrease with the resolution of inflammation or trauma. The concentration increase of CRP in blood may last for several days before decreasing to normal levels. As elevated CRP values are always associated with pathological changes, the CRP assay provides useful information for the diagnosis, therapy and monitoring of inflammatory processes and associated disease. As increases in CRP values are non-specific, they should not be interpreted without a complete patient evaluation, and measurements of CRP should be compared to previous values. Materials provided One PreventID CRP 1/3 test kit contains the following items to perform the test: 1. Test device (in aluminium pouch) 2. Blood sample dropper (in aluminium pouch) 3. Bottle with buffer solution 4. Instructions Further needed: Alkohol pad, sterile lancet, clock. Storage The PreventID CRP 1/3 should be stored at room temperature. The test device is sensitive to humidity as well as to heat. Therefore, perform the test immediately after removing the test device from the foil pouch. Precautions 1. For in vitro diagnostic use only. 2. Do not use the test device beyond the expiry date. 3. Do not use the test if the aluminium pouch is torn or if the membrane of the rapid test device is visibly damaged. 4. Perform the test immediately after removing the test device from the foil pouch. 5. The same lancet needle should be used for one person only and should not be shared with another person, because the used lancet is a biohazard. 6. Decontaminate and dispose of all specimens, reaction kits, lancet needles and potentially contaminated materials as if they were infectious waste in a biohazard container. Procedure of the test 1. Remove the test device and the blood sample dropper from the foil pouch, and place it on a flat, dry surface. 2. Clean the second or third finger by rubbing it with an alcohol pad. 3. Prick fingertip with a sterile lancet. 4. Massage near the site to obtain blood flow. Place the tip of the blood sample dropper into the blood sample and make sure the blood sample dropper is slightly lower than the blood sample so that the blood will automatically flow into the dropper. Fill the dropper with blood sample until it reaches the black line (Fig. 1). If insufficient blood sample, massage near the site again to obtain more blood flow and fill the blood sample dropper to the black line. 5. Then place the tip of the blood sample dropper vertically into the sample well of the test device.place two fingers over the vent hole of the blood sample dropper (blocking air flow) and squeeze the top of the blood sample dropper to expel the blood sample (about 40 µl) into the sample well (Fig. 2). Fig. 1: Filling the dropper with blood Note: If the vent hole is not completely blocked (not pictured in Fig. 2!), blood sample will not be completely expelled from the tube. 6. Open the buffer bottle and hold it upside down. Make sure holding the bottle vertically (Note: drops may contain air-bubbles if not holding the buffer bottle vertically), add 4 hanging drops of buffer into the sample well. 7. As the test begins to work, you will see purple color dyes move across the result window in the center of the test device. 8. Interpret test results at 5 minutes. Do not interpret test results after 7 minutes. Caution: The above interpretation time is based on reading the test results at room temperature of 15 C to 30 C. C R T Fig. 2: Expelling the blood sample into the sample well

3 Manual (for professional use) Interpretation of the test (Fig. 3) Fig. 3 a b Fig. 3a-e: Interpretation of the test C R T CRP < 1 mg/l CRP 1 mg/l mg/l to bis < 33 mg/l CRP = 3 mg/l C: C: Control band band c c R: R: Reference band band T: T: Test Test band band CRP > 3 mg/l d invalid ee C R T C R TT C R T C R T 1. A color band will appear at the left section of the result window to show that the test is working properly. This band is the control band ( C band). 2. The middle section of the result window indicates the reference band ( R band). 3. The right section of the result window indicates the test band ( T band). CRP concentration less than 1 mg/l: Control- and reference bands are visible. The test band is not visible, indicating that CRP level is less than 1 mg/l (Figure 3a). CRP concentration less than 1.0 mg/l = low relative risk for CVD CRP concentration of 1 mg/l to less than 3 mg/l: Control-, reference and test bands are visible. The intensity of the test band (T) is weaker than the intensity of the reference band (R) indicating that CRP level is 1 mg/l to less than 3 mg/l (Figure 3b). CRP concentration between 1.0 mg/l and 3.0 mg/l = average relative risk for CVD CRP concentration of 3 mg/l: Control-, reference- and test bands are visible. The intensity of the test band (T) is similar to the refe rence band (R) indicating that CRP level is 3 mg/l (Figure 3c). CRP concentration of 3.0 mg/l = average relative risk for CVD CRP concentration higher than 3 mg/l: Control-, reference- and test bands are visible. The intensity of the test band (T) is darker than the reference band (R) indicating that CRP level is higher than 3 mg/l (Figure 3d). CRP concentration higher than 3 mg/l = high relative risk for CVD Invalid: If after performing the test, no color band for the reference band and/or the control band is visible within the result window, the result is considered invalid. Some causes of invalid results are not following the directions correctly, such as insufficient amount of sample or buffer added or the test may have deteriorated beyond the expiration date (Figure 3e). Note: Generally, the higher the CRP level in the specimen, the stronger the T band color will be. Very higher CRP level specimens can cause reduced T band color intensity (so called Hook Effect ). Note: A positive result will not change once it has been established at 5 minutes. However, in order to prevent any incorrect results, the test result should not be interpreted after 7 minutes. Interpreting test results after 7 minutes, the sensitivity of the test will be higher than 1 mg/l. Some specimens with a high rheumatoid factor concentration may yield a nonspecific positive result. CRP generally shows an increase in the presence of bacterial infections or in patients with acute or chronic inflammatory diseases. The PreventID CRP1/3 test for risk stratification of CVD should therefore be carried out only in apparently healthy people. Limitations of the Test Although the PreventID CRP 1/3 is very accurate in detecting CRP, a low incidence of false results can occur. Other clinically available tests are required if questionable results are obtained. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated. References: 1. Ridker et al. (2002) N Engl J Med 347 : Ridker et al. (2000) N Engl J Med 342 : Rifai N, Ridker PM (2001) Clin Chem 47: Short instructions for the handling of PreventID CRP 1/3 1. Prick fingertip with a sterile lancet. 2. Let the blood flow into the blood sample dropper until it reaches the black line. 3. Expel the blood sample into the sample well. 4. Add four hanging drops of buffer into the sample well. 5. Interpret test result at 5 minutes. Do not interpret test results after 7 minutes. Distributed by: Preventis GmbH Stubenwald-Allee 8a Bensheim, Germany Phone: Fax: info@preventis-online.de Storage temperature In vitro diagnostic device Catalogue number Read instruction before use Contains sufficient for <n> tests Status: US: all products: Research Use Only. Not for use in diagnostic procedures. Manufacturer Lot number Expiry date Do not reuse MPC INTERNATIONAL S.A. 26, Boulevard Royal 2449 Luxembourg, Luxembourg

4 Medical information CVD Risk factor High sensitive CRP PreventID CRP 1/3 Semi-quantitative hscrp rapid test for the prediction of first and recurrent cardiovascular events disease (CVD) is the worlds leading cause of death, and as such, represents a serious global health problem. In the industrialised world, about half of deaths from cardiovascular disease are due to coronary heart disease and another quarter due to stroke. Although CVD is often thought to primarily affect men and older people, it is in fact a major cause of death for both men and women in the prime of life. The risk factors are well known: Causal risk factors Potential risk factors Predisposing factors cholesterol increase of obesity LDL-elevation triglycerids physical inactivity HDL-decrease lipoprotein (a) family history high blood pressure homocysteine gender smoking fibrinogen insulin resistance diabetes mellitus small dense LDL socio-economic factors plasminogen activator inhibitor (PAI) age C-reactive protein (CRP) Table: Causal, potential and predisposing risk factors for coronary heart diseases People who have one or more of these risk factors should if possible try to eliminate them and should have regular medical check ups. Inflammation is involved in plaque initiation and progression Inflammation plays a crucial role in the initiation, growth and destabilization of atherosclerotic plaques that lead to clogged arteries and most heart attacks. The inflammatory marker C-reactive protein (CRP) is an important risk factor for atherosclerosis and coronary heart disease (Ridker et al., 1997; Shah, 2000). Furthermore, basal levels of CRP, in the absence of apparent inflammatory disease (so-called hs CRP), may be informative in predicting future myocardial or cerebrovascular events (Ridker 2002). CRP is an acute phase reactant produced by the liver in response to cytokine release during inflammation. CRP deposits in the arterial wall during atherogenesis and colocalizes with the terminal complement complex and with foam cells. CRP upregulates adhesion molecule expression on endothelial cells. It both opsonizes biological particles and binds to apolipoprotein-b-containing lipoproteins (LDL and VDLD). 50 % of all heart attacks occur to people with normal cholesterol levels A large prospective study of nearly 28,000 women age 45 and older examined the risk for a first-time cardiovascular disease event (eg., heart attack or stroke) over an eight-year follow-up period. At the start of the study both LDL and hscrp levels were measured. Women with either higher levels of hscrp or higher levels of LDL in their blood were much more likely to suffer a first cardiovascular event than were women who had lower levels of both hscrp and LDL.

5 Medical information We will gladly send further information about this test and our other point-of-care diagnostics on request Women with higher levels of CRP were actually somewhat more likely to experience a heart attack or stroke than were women with higher levels of LDL-cholesterol compared to those with the lowest levels (Ridker, 2000; see Fig. 1 ). The bottom line of this study is: high hscrp levels may identify high-risk patients who would be missed by just measuring cholesterol levels. As a matter of fact, half of all heart attacks occur in people with normal cholesterol levels. Furthermore, high CRP-levels and an elevated ratio of total cholesterol to HDL are independent prognostic parameters for future cardiovascular events (Koenig et al., 2004). Primary prevention with the PreventID CRP 1/3 A simple method to recognize and predict first and recurrent cardiovascular events is to detect hs CRP in blood from the fingertip with the PreventID CRP 1/3. This rapid test reveals within 5 minutes if CRP is less than 1 mg/l, 1 to 3 mg/l or greater than 3 mg/l. The result is the basis for further diagnostic interventions. If the CRP concentration is higher than 3 mg/l it should be repeated in about two weeks. If CRP is elevated repeatedly and after exclusion of concurrent causes (e. g., acute infection, trauma, chronic inflammatory diseases of other origin) CRP can be used for risk stratification. What the results indicate: CRP < 1 mg/l low relative CVD-risk CRP 1 3 mg/l average CVD-risk CRP > 3 mg/l high CVD-risk (Pearson et al. 2003) a b medium hscrp concentration (mg/dl) Homocysteine total Relative risk of future cardiovascular events baseline level Figure1: a) Relative risk of cardiovascular events among apparently healthy postmenopausal women according to different parameters (from Ridker et al., 2000). b) Medium hscrp serum levels before and 5 years after treatment with Pravastatin or a Placebo (from Blake and Ridker, 2001). Literature Koenig W et al. (2004) Circulation 109: Pearson TA et al. (2003) Circulation 107: Ridker P et al. (1997) N Engl J Med : 336 : Ridker P et al. (2000) N Engl J Med 342: Ridker P et al. (2002) N Engl J Med 342: Shah (2000) Circulation 101: Placebo level after 5 years Simple performance of the PreventID CRP 1/3 Fig. 2a Fig. 2b C R T Prick fingertip with a sterile lancet. Let the blood flow into the blood collection tube until it reaches the black line (Fig. 2a). Expel the blood sample into the sample well (Fig. 2b). Add 4 hanging drops of buffer into the sample well. Interpret test result at 5 minutes (Fig. 2c). Do not interpret test results after 7 minutes or later. June 2015 C R T Fig. 2c a b CRP < 1 mg/l CRP 1 mg/l mg/l to bis < 33 mg/l CRP = 3 mg/l C: C: Control band band c R: R: Reference band band T: T: Test Test band band CRP > 3 mg/l e d invalid C R T C R TT C R T C R T US: all products: Research Use Only. Not for use in diagnostic procedures. Preventis GmbH Stubenwald-Allee 8a Bensheim, Germany Phone: Fax: info@preventis-online.de

6 Scientific background Produced by hepatocytes, C-reactive protein (CRP) is a non-specific, acute-phase reactant indicating acute injury, bacterial infection and inflammation. CRP is also an indicator of myocardial infarction and elevated levels of CRP are a good predictor of future cardiac diseases [1, 2, 3]. Although the detection of elevated levels of CRP in the serum is not specific for any particular disease, it is a useful indicator of inflammatory processes. CRP levels rise in blood within 24 to 48 hours following acute tissue damage, reach a peak during the acute stage and decrease with the resolution of inflammation or trauma. The concentration increase of CRP in blood may last for several days before decreasing to normal levels. As elevated CRP values are always associated with pathological changes, the CRP assay provides useful information for the diagnosis, therapy and monitoring of inflammatory processes and associated disease. As increases in CRP values are non-specific, they should not be interpreted without a complete patient evaluation, and measurements of CRP should be compared to previous values. References Ridker et al. (2002) N Engl J Med 347 : Ridker et al. (2000) N Engl J Med 342 : Rifai N, Ridker PM (2001) Clin Chem 47: Some specimens with a high rheumatoid factor concentration may yield a nonspecific positive result. CRP generally shows an increase in the presence of bacterial infections or in patients with acute or chronic inflammatory diseases. The PreventID CRP1/3 test for risk stratification of CVD should therefore be carried out only in apparently healthy people.

7 Questions & answers Why test for highly sensitive CRP (hs-crp)? The American Heart Association and the Centers for Disease Control and Prevention (AHA/CDC; Pearson et al Circulation 107: ) propose measuring hs-crp as an adjunct to the major risk factors to further assess absolute risk of coronary disease and for primary prevention. Testing hs-crp may be helpful in deciding future therapy in people whose 10-year risk for coronary heart disease is between 10 and 20%. What does CRP 1/3 mean? CRP 1/3 means the detection of c-reactive protein near the normal range (CRP concentration from less than 1 mg/l up to a concentration of up to 10 mg/l). CRP in this range is also called highly sensitive CRP. Which patients should I test for highly sensitive CRP with the PreventID CRP 1/3? How can the test result of the PreventID CRP 1/3 be interpreted? This rapid test shows within 5 minutes if CRP is less than 1 mg/l, 1 to 3 mg/l or greater than 3 mg/l. What the results indicate: CRP < 1 mg/l : CRP 1-3 mg/l : CRP > 3 mg/l : low relative CVD-risk average CVD-risk high CVD-risk The result is the basis for further diagnostic interventions. Is there any medication that interferes with the PreventID CRP 1/3? The test is not influenced by medications. However, the intake of statins or anti-inflammatory drugs may decrease the CRP concentration in the circulation. The PreventID CRP 1/3 should be integrated in a preventive medical check up for the assessment of cardiovascular risk. The American Heart Association and the Centers for Disease Control and Prevention recommend CRP screening if people have an intermediate risk - a 10 percent to 20 percent chance - of developing coronary heart disease within the next 10 years. The test can help to decide on further evaluations or whether more aggressive treatment in an attempt to prevent disease is needed. What about patients who have caught a cold: is the PreventID CRP 1/3 recommended in these patients? CRP generally shows an increase in the presence of bacterial infections or in patients with acute or chronic inflammatory diseases. The PreventID CRP 1/3 test for risk stratification of CVD should therefore only be carried out in apparently healthy people.