should be discarded after single use. 1.

According to standard phlebotomy procedure, collect a venipuncture whole

hsCRP Rapid Quantitative Test 13. The Test Cartridge and Finecare™ FIA System should be used away from
vibration and/or magnetic field. During normal usage, the Test Cartridge may
produce minor vibrations which should be regarded as normal. Do not pull out
blood specimen with a blood collection tube which contains suitable
anticoagulant (EDTA).
2. It is recommended that specimens should be tested immediately. Do not leave
Catalog No. W240 the ID Chip when test is in procedure. the specimens at room temperature for prolonged period. If the specimens are
14. Do not smoke, eat, or drink in the areas where specimens or test reagents are not tested immediately, they should be kept at 2℃~8℃.
being handled. 3. It is not suitable to test the whole blood specimens which have been kept at 2℃
INTENDED USE sandwich immunodetection method, when sample is added to the sample well of 15. Blood specimens, used Test Cartridges, Pipette Tips and Detection Buffer ~8℃ for more than 2 days.
the test, the fluorescence-labeled detector CRP antibody on the membrane binds vials are potentially infectious. They should be handled carefully and
The Finecare™ hsCRP Rapid Quantitative Test is a fluorescence immunoassay to CRP antigen in blood specimen and they form immune complexes. As the disposed by an appropriate method in accordance with relevant local For Serum and Plasma:
used along with Finecare™ FIA System (Model No.: FS-112/FS-113/FS-205) for complexes migrate on the nitrocellulose matrix of test strip by capillary action, the regulations. 1. According to standard phlebotomy procedure, collect a venipuncture whole
quantitative determination of C-Reactive Protein (CRP) in human whole blood, complexes of detector antibody and CRP are captured to CRP antibody that has 16. The Finecare™ hsCRP Rapid Quantitative Test should be interpreted by the blood specimen. If you need to collect plasma, please use a blood collection
serum or plasma. been immobilized on test strip. Thus the more CRP in blood specimen, the more physician along with clinical findings and other laboratory test results. tube which contains suitable anticoagulant (EDTA).
complexes accumulated on test strip. Signal intensity of fluorescence of detector 17. The test should be applied on a routine basis but not in emergency situations. 2. Separate the serum/plasma from blood as soon as possible to avoid hemolysis.
hsCRP is a sensitive index to distinguish the low level inflammatory state, which antibody reflects the amount of captured CRP and FinecareTM FIA System shows 3. Test should be performed immediately after specimen collection. Do not leave
can be used as an auxiliary means for risk identification of cardiovascular disease. CRP concentrations in blood specimen. The default results unit of FinecareTM MATERIAL the specimens at room temperature for prolonged period. Specimens could be
The serum CRP level is closely related to the occurrence, severity and prognosis hsCRP Rapid Quantitative Test is displayed as XXX mg/L from FinecareTM FIA kept at 2℃~8℃ not exceed 7 days. For long time storage, specimens should be
of cardio-cerebrovascular diseases such as atherosclerosis (AS) and acute System. Material Provided kept below -20℃.
cerebral infarction (ACI). In conjunction with the traditional clinical diagnosis of
acute coronary syndrome, it can be used as an early warning indicator for the PRECAUTIONS Components of Finecare™ hsCRP Rapid Quantitative Test: Note: Bring specimens to room temperature before testing. Frozen
recurrence of coronary artery disease or acute coronary syndrome. specimens must be completely thawed and mixed well prior to testing.
1. For in vitro diagnostic use only. For single-use only. • Test Cartridge in a sealed pouch with desiccant 25 Specimens should not be frozen and thawed repeatedly. Only clear,
For in vitro diagnostic use only. For professional use only. 2. The desiccant is for storage purposes only, and is not used in test procedures. • ID Chip 1 non-hemolytic specimens can be used.
Do not swallow. • Detection Buffer (volume: 0.5mL) 25
SUMMARY 3. Lot number of all the test components (Test Cartridge, ID Chip and Detection • Pipette Tip 25 TEST PROCEDURE
Buffer) must match with each other. • Leaflet with instructions for use 1
The C-Reactive Protein (CRP) is synthesized by the liver in response to 4. Do not interchange the test components from different lots or use the test For complete information and operating procedures, please refer to Finecare™
interleukin-6 and well known as one of the classical acute-phase reactants and as components beyond the expiration date printed on package. Material Required But Not Provided FIA System Operation Manual. Test should be performed at room temperature.
a marker of inflammation. The serum CRP level may rise from a normal level of <5 5. The Test Cartridge should remain in its original sealed pouch until use. Do not Step 1: Preparation
mg/L to 500 mg/L during the body’s general, non-specific response to infectious use the Test Cartridge if the pouch is damaged or already opened. Do not use • Finecare™ FIA System Before testing, select the "Sample type" and "Test mode" from the instrument
and other acute inflammatory events. For some time, the measurement of CRP a damaged ID Chip. Do not touch the insertion end of the ID Chip. • Transfer Pipette Set (100 μL size) based on actual use.
concentration has been used as a clinical tool for monitoring autoimmune 6. Protective measures should be taken when sample collection, handling, • Specimen Collection Containers Ensure that the lot number of the Test Cartridge matches ID Chip as well as the
diseases and infectious processes. It has recently been suggested that a marker storage, mixing and testing. • Centrifuge (for serum/plasma specimen only) Detection Buffer. Insert ID Chip into Finecare™ FIA System.
of inflammation, along with serum cholesterol, may be critical component in the 7. The Finecare™ hsCRP Rapid Quantitative Test kit is only operated in Fineca™ • Timer Step 2: Sampling
development and progression of atherosclerosis. A growing body of evidence has FIA System. Tests should be applied by professionally trained staff working in Draw 10 μL of whole blood or serum or plasma with a transfer pipette and add into
supported the idea that cardiovascular diseases including coronary heart disease, certified laboratories and clinics at which the sample is taken by qualified STORAGE AND STABILITY the Detection Buffer tube.
ischemic stroke, and acute myocardial infarction, develop, at least in part, medical personnel. Step 3: Mixing
because of a chronic, low-level CRP of the vascular endothelium. Apparently, 8. Do not use whole blood specimen when hemolysis or blood clot appears. 1. Store the test kit at 4℃~30℃ up to the expiration date printed on package. Close the lid of Detection Buffer tube and mix the sample mixture thoroughly by
high-sensitivity CRP (hsCRP) is emerging as the strongest and most independent 9. Disappearance of the blue line on the right of the result window of the test 2. If removed from refrigerator, allow the test kit for 30 minutes to return to room shaking it about 10 times.
predictive risk factor for atherosclerosis and cardiovascular diseases（CVD）. indicates the test cartridge has been used. temperature before testing. Step 4: Loading
American Heart Association (AHA) and the Centers for Disease Control and 10. For insufficient sample or incomplete migration over the marker line, the 3. Do not remove the Test Cartridge from the pouch until use. The Test Cartridge Pipette 75 μL of sample mixture and load it into the sample well of the Test
Prevention (CDC) issued a statement regarding use of C-reactive protein to System indicates “no sample /insufficient sample”, this test should be should be used within 1 hour once opened. Cartridge.
assess risk of CVD. discarded. Step 5: Testing
11. Do not insert a wetting Test Cartridge into the Finecare™ FIA System SPECIMEN COLLECTION AND PREPARATION There are two test modes for Finecare™ FIA System, Standard Test mode and
PRINCIPLE otherwise it will contaminate or damage the instrument. Quick Test mode. Please refer to the Operation Manual of Finecare™ FIA System
12. A Detection Buffer vial and Pipette Tip should be used for processing one The test can be performed with either serum or plasma or whole blood. for details.
The FinecareTM hsCRP Rapid Quantitative Test is based on fluorescence sample only. Similarly a Test Cartridge should be used for testing one
immunoassay technology. The FinecareTM hsCRP Rapid Quantitative Test uses a processed sample only. Both the Detection Buffer vial and the test cartridge For Whole Blood Collected by Venipuncture： a) For Standard Test mode: Insert the Test Cartridge onto the Test Cartridge
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 holder of Finecare™ FIA System right after adding sample mixture to the Interferents Acceptable range further ischemic events in first-ever transient ischemic attack or stroke patients
sample well. Press “Test” to start testing. (Apply to FS-112, FS-113 and 1. This test has been developed for testing human whole blood, serum, plasma with intracranial large-artery occlusive disease [J]. Stroke, 2003,34:2463-2468.
FS-205) specimen only. cholesterol ＜1 mg/mL 9. Scirica BM, Morrow DA, Cannon CP，et al． Clinical application of C－ reactive
2. The test procedure, precautions and interpretations of results for this test must bilirubin ＜0.5 mg/mL protein across the spectrum of acute coronary syndrome [J]．Clinical
b) For Quick Test mode: Set the timer and count down right after adding sample be followed when testing. Chemistry, 2007,53 (10): 1800-1807．
mixture into the sample well and leave it at room temperature for 3 minutes. 3. The results of Finecare™ hsCRP Rapid Quantitative Test should be evaluated triglycerides ＜75mg/mL 10. Avanzas P, Arroyo－Espliguero R, Cosin－Sales J，et al. Markers of
Then insert the Test Cartridge onto the Test Cartridge holder of Finecare™ FIA with all available clinical and laboratory data. inflammation and multiple complex stenoses (pancoronary plaque vulnerability)
System. Press “Test” to start testing. Finecare™ FIA System will start scanning 4. The false positive results include cross-reactions with some components of Linearity in patients with non － ST segment elevation acute coronary syndromes [J]．
the sample-loaded Test Cartridge immediately. (Apply to FS-112 and FS-113). serum from individual to antibodies; and non-specific adhesion of some Heart, 2004, 90 (8): 847-852．
components in human blood that have similar epitopes to capture and detector A serial concentration of CRP within 0.1mg/L~10mg/L were tested for three times 11. Lu L, Pu LJ, Xu XW, et al. Association of serum levels of glycated albumin, C－
Results are displayed on main screen and can be printed out by press “Print”. antibodies. In the case of false negative results, the most common factors are: each with the same batch Test Cartridges, the Correlation Coefficient (R) is≥ reactive protein and tumor necrosis factor－α with the severity of coronary
Discard the used Test Cartridge according to local regulations and procedures non-responsiveness of antigen to the antibodies by that certain unknown 0.9900. artery disease and renal impairment in patients with type 2 diabetes mellitus [J].
after released from Finecare™ FIA System. components are masking its epitope, such that antigen cannot be seen by the Clinical Biochemistry, 2007, 40 (11): 810-816.
antibodies; instability of CRP antigen, resulting in degradation with time and, or Precision
INTERPRETATION OF RESULTS temperature, such that they become no longer recognizable by antibodies; and
degraded other test components. The effectiveness of the test is highly Within-run precision: INDEX OF SYMBOLS
The Finecare™ FIA System calculates hsCRP test results automatically and dependent on storage of kits and specimens at optimal conditions. Determined by using 20 Test Cartridges in the same batch to test with CRP, the
displays the exact concentrations of CRP on the screen as form of XXX mg/L. For 5. Other factors may interfere with Finecare™ hsCRP Rapid Quantitative Test and C.V. is ≤10%.
further information, please refer to the Operation Manual for the Finecare™ FIA may cause erroneous results. These include technical or procedural errors, as In Vitro See Instruction
Expiry Date
Diagnostic Use for Use
System. well as additional substances in blood specimens. Between-run precision:
Determined by using 60 Test Cartridges in 3 random and continuous batches to
American Heart Association (AHA) suggests that the risk of cardiovascular TRACEABILITY test with CRP, the C.V. is ≤15%. Manufacturing
Tests per Kit Keep Dry
disease can be categorized according to the hsCRP level: Date
The metrological traceability of values assigned to calibrators can be traced to: BIBLIOGRAPHY OF SUGGESTED READING
Concentration Clinical Reference
≤1.0 mg/L Low CVD risk International standard CRM 470 protein reference 1. Haim M, Benderly M, Tanne D, et al. C-reactive protein, bezafibrate, and Batch Number
Authorized Keep away from
Representative Sunlight
reference material material（IFCC） recurrent coronary events in patients with chronic coronary heart disease [J].
1.0~3.0 mg/L Moderate CVD risk
Am Heart J, 2007, 154: 1095-1101.
≥3.0 mg/L High CVD risk PERFORMANCE CHARACTERISTICS 2. Ridker PM, Hennekens CH, Buring JE, et al. C-reactive protein and other Store between
Do not reuse Catalog #
4～30℃
markers of inflammation in the prediction of cardiovascular disease in women
Note: Accuracy [J]. N Engl J Med, 2000, 342:836-843.
1) This reference interval is established only for clinical trial samples, due to 3. Aukrust P, Halvorsen B, Yndestad A, et al. Chemokines and cardiovascular risk
Manufacturer
geographical, ethnic, gender and age differences, it is recommended that A comparative study is tested for 210 clinical samples in using Finecare™ hsCRP [J]. Arterioscler Thromb Vasc Biol, 2008, 28:1909-1919.
the laboratory to establish their own reference interval. Rapid Quantitative Test and the Roche hsCRP reagent kit. 4. Morrow DA, de Lemos JA, Sabatine MS, et al. Clinical relevance of C-reactive
2) The laboratorial test results vary from analysis methods, sample storage time The Correlation Coefficient (R) is 0.989. protein during follow-up of patients with acute coronary syndromes in the Gangzhou Wondfo Biotech Co., Ltd.
and individual difference. The physician should judge comprehensively on Aggrastat-to-Zocor Trial [J]. Circulation, 2006, 114:281-288. No.8 Lizhishan Road, Science City, Luogang District, 510663,
the results. Assay Range and Detection Limit 5. Pearson TA, Mensah GA, Alexander RW, et al. Markers of inflammation and Guangzhou, P.R.China
cardiovascular disease: application to clinical and public health practice: A
QUALITY CONTROL Assay Range: 0.1mg/L~10mg/L statement for healthcare professionals from the Centers for Disease Control
Detection Limit: ≤ 0.1mg/L and Prevention and the American Heart Association [J]. Circulation,
Each Finecare™ hsCRP Rapid Quantitative Test Cartridge contains internal 2003,107:499-511. Qarad b.v.b.a.
control that satisfies routine quality control requirements. This internal control is Cross-Reactivity 6. Jiang S, Bao Y, Hou X, et al. Serum C-reactive protein and risk of Cipalstraat 3
performed each time a patient sample is tested. This control indicates that the Test cardiovascular events in middle-aged and older chinese population [J]. Am J B-2440 Geel, Belgium
Cartridge was inserted and read properly by Finecare™ FIA System. The following substances do not interfere with the test results at the indicated Cardiol, 2009, 103: 1727-1731.
An invalid result from the internal control causes an error message on concentrations: 7. Tuttolomondo A, Di Sciacca R, Di Raimondo D, et al. Inflammation as a
Finecare™ FIA System indicating that the test should be repeated. therapeutic target in acute ischemic stroke treatment [J]. Curr Top Med Chem,
2009, 9: 1240-1260.
LIMITATIONS OF PROCEDURE 8. Arenillas JF, Alvarez-Sabin J, Molina CA, et al. C-reactive protein predicts
Rev. A1 Rel.: 2019/01/28
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