gabControl® – CrP (10-30) Test for semiquantitative detection of CrP. Product ID: M07CR03 Rapid diagnostic test for semiquantitative detection of CrP in whole blood, serum or plasma For professional in vitro diagnostic use only. INTENDED USE • The test should be carried out immediately after taking the sample. Do not store The gabControl® CrP Test is a rapid chromatographic immunoassay for the samples at room temperature for any length of time. Do not freeze whole blood. Whole semiquantitative detection of CrP in whole blood, serum or plasma for the verification and blood taken from the fingertip should be tested immediately. observation of inflammations caused by e.g. bacterial infections or arteriosclerosis. The • If the samples are to be sent out then they must be packaged in accordance with local sensitivity is 10 mg/l with a 30 mg/l reference line. regulations governing the transport of pathogenic agents. SUMMARY PACKAGE CONTENTS CrP is an acute phase protein whose concentration in the blood rises in case of both gabControl® CrP Test infectious and non-infectious diseases, but especially in case of bacterial infections. CrP is Disposable droppers also present in healthy individuals, with 10 mg/l regarded as the normal level for adults. CrP Micropipette (10 µl) is a non-specific marker of inflammation which is also used e.g. for the evaluation of Buffer inflammatory diseases. If increased CrP levels are observed in otherwise healthy individuals Mixing tube free of inflammation, then this constitutes a risk factor for arteriosclerosis. Increased CrP Package insert levels must always also be diagnosed independently of clinical symptoms. CrP has become the most important non-specific parameter in the diagnosis of inflammation because it still increases before a non-suspicious leukocyte count or fever and also returns to normal very MATERIALS REQUIRED BUT quickly after the inflammation has cleared up. CrP can be used to track the progression of NOT SUPPLIED an illness. Viral infections are accompanied by only marginal increase in CrP levels. Sample collecting container The CrP concentration in the blood can give an indication of the severity of an illness: (for whole blood from arm vein) < 10 mg / l: Normal level for adults Lancet (only for whole blood sample from fingertip) 10 - 50 mg / l: Slight or local inflammation Centrifuge > 50 mg / l: Severe inflammation Laboratory pipette with 3.5 µl tip > 100 mg / l: Serious illness, sepsis, bacterial meningitis, etc. (or appropriate capillary tube) The gabControl® CrP Test detects CrP in whole blood, serum or plasma and gives a Timer semiquantitative and selective result within minutes. The sensitivity is 10 mg/l with a 30 mg/l reference line. TEST PROCEDURE PRINCIPLE 1 Before starting test procedure allow gabControl® CrP Test card, specimen, buffer The gabControl® CrP Test is a semiquantitative membrane-based immunoassay for the and/or controls to reach room temperature (15-30°C). 2 Remove the gabControl® CrP Test from the foil pouch and use as soon as detection of CrP in whole blood, serum or plasma. The membrane is coated with CrP antibodies in the test line area. During the test the sample reacts with the particles coated possible afterwards. Lay the test materials on a clean and level surface. with the anti-CrP antibodies. The mixture migrates chromatographically along the 3 Put 10-12 drops of the buffer solution in the mixing tube. membrane by capillary action and reacts with the CrP antibodies held on the membrane Hold the tube vertically as you do so to prevent trapped air. and generates a coloured line. If the CrP concentrations in the sample are below the cut-off point then no coloured line will appear in the test area: this indicates a negative result (<10 mg/l). If a test line (T) appears which is fainter than the reference line (R), this indicates that the CrP concentration in the sample is between 10-30 mg/l. A test line (T) with identical or near- identical intensity to the reference line (R) indicates that the CrP concentration in the sample is around 30 mg/l. A test line (T) which is brighter than the reference line (R) indicates that the CrP concentration in the sample is above 30 mg/l. A coloured line will always appear in the control line area (C) where it acts as a procedural control indicating that the correct size of sample has been taken and verifying full penetration of the membrane. 4A Whole blood samples Fill the micropipette (provided with the kit) with approx. 10 µl of the PRECAUTIONS whole blood sample from the vein or the whole blood sample from • For professional in vitro diagnostic use only. the fingertip and transfer it to the mixing tube filled with buffer • Do not use beyond the expiry date. solution. • Keep the test cassette in its sealed pouch until use. • Do not eat, drink or smoke when handling samples and tests. • Do not use the test if the pouch is damaged. • All samples and controls must be treated as infectious material. Observe any precautionary measures which have been put in place and follow the standard procedures for correct disposal of specimens and control samples. • Wear appropriate protective clothing when examining the samples (laboratory coat, disposable gloves and safety glasses). • Dispose of the used test in accordance with local requirements. • Humidity and temperature may adversely affect the results. STORAGE AND SHELF LIFE Store as packaged in the sealed pouch either at room temperature or refrigerated (2-30°C). The test can be used until the expiry date printed on the sealed pouch and should be kept in the sealed pouch until used. DO NOT FREEZE. Do not use after the expiry date. 4B Serum or plasma samples SPECIMEN COLLECTION AND PREPARATION Fill the laboratory pipette or capillary tube (not provided with the • The gabControl® CrP Test can be carried out with whole blood (from the arm vein or kit) with approx. 3.5 µl of serum or plasma and transfer it to the fingertip), serum or plasma. mixing tube filled with buffer solution. • Extraction of whole blood from the vein: Collect blood samples with anticoagulants (Na-heparin) using standard laboratory procedures. • Extraction of whole blood from the fingertip: • Clean the patient's hand with soap and warm water or with an alcohol-impregnated wipe. Allow to dry. • Massage the hand towards the tip of the middle finger or ring finger without touching the prepared needle entry point. • Puncture the skin with a sterile lancet. Wipe away the first drop of blood. • Gently rub the palm of the hand from the wrist towards the finger to form a drop of blood at the needle entry point. • Collect the blood with the end of the micropipette supplied until about 10 µl has been collected (to black line). Avoid trapping air. • Put a dispensing bulb on the top end of the capillary tube (neither item included in package contents) which, when squeezed, will deposit the blood sample on the test device sample well. • Serum or plasma should be separated from the blood as soon as possible to prevent haemolysis. Use clear, non-haemolysed samples only. 5 Mix buffered sample in tube thoroughly. gabControl® – CrP (10-30) Test for semiquantitative detection of CrP. Product ID: M07CR03 6 Add 3 drops of specimen mixture to QUALITY CONTROL the specimen well. The test incorporates a procedural check. The appearance of coloured lines in the control area (C) and the reference area (R) is considered as a built-in procedural check. It confirms the presence of sufficient sample, complete membrane wicking and correct execution of the test. Control standards are not supplied with this test kit. It is advisable to check positive and negative controls using standard laboratory practice in order to confirm the accuracy of the test procedure and the test results. LIMITATIONS 1. The gabControl® CrP Test is for professional in vitro diagnostic use only. The test is designed exclusively for semiquantitative detection of CrP in whole blood, serum or plasma. 7 Wait for the red line(s) to appear. The result should be 2. The gabControl® CrP Test only indicates the semiquantitative concentration of CrP interpreted after 5 minutes. Result must be interpreted within in the sample and should not be the only factor taken into consideration when 7 minutes. diagnosing inflammations or arteriosclerosis. 3. As with all diagnostic tests, all the results available to the physician must be interpreted in conjunction with other clinical information. INTERPRETING THE RESULTS 4. Should the test result be negative but the clinical symptoms persist, it is advisable to POSITIVE: Three distinct coloured do further tests or adopt other clinical methods. A negative result does not ever rule lines appear. out the potential presence of a bacterial inflammation at some time. A: The test line (T) is fainter than the 5. Viral inflammations cannot be detected with this test. reference line (R), indicating that the 6. Extremely high CrP concentrations can have a "prozone effect" which can decrease CRP concentration in the sample is the intensity of the T line. This effect can be observed with CrP concentrations > between 10-30 mg/l. 1,000 mg/l. 7. Samples with abnormally high rheumatoid factors can affect the result and bring about non-specific positive results. B: The test line (T) is close to the reference line (R) in intensity, Interfering substances indicating that the CRP concentration Samples were mixed with the following potentially interfering substances: in the sample is around 30 mg/l. Acetaminophen 20 mg/dl Glucose 2 g/dl Acetylsalicylic acid 20 mg/dl Haemoglobin 500 mg/dl Ascorbic acid 20 mg/dl Ketone 40 mg/dl Atropine 20 mg/dl Mestranol 3 mg/dl Bilirubin 60 mg/dl Nitrite 20 mg/dl Caffeine 20 mg/dl Tetracyclines 20 mg/dl C: The test line (T) is brighter than Creatinine 20 mg/dl Na-heparin 3 mg/dl the reference line (R), indicating that Gentisic acid 20 mg/dl Li-heparin 3 mg/dl the CRP concentration in the sample None of the substances in the concentrations tested interfered with the gabControl® is over 30 mg/l. CrP Test. LITERATURE 1. Caswell M. Effect of patient age on tests of the acute-phase response. Arch Pathol Lab Med 1993;117:906–909. NEGATIVE: Two coloured lines 2. Anderson R , Hugander A , Ghazi S , Ravan H , Offenbartl S, Nystron P et al. appear in the control and reference Diagnostic value of disease history, clinical presentation and inflammatory areas. No distinct coloured line parameters of appendicitis. World J Surg 1999;23(2):133-40. appears in the test area (T). Rev.: 25/04/2008 (TL) The concentration in the sample is below 10 mg/l. MEANING OF SYMBOLS INVALID: No control line (C) and/or reference line (R). Insufficient amount of specimen or incorrect procedure are the most likely reasons why the control and reference lines fail to appear. Check the procedural stages and carry out the test with a new test. If the problem persists, discontinue using the test pack immediately and contact your supplier.