Anti-Cyclic Citrullinated Peptide (CCP) Assay Kit – Bulk Reagents

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Selling unit: per 100ml

Product Name

  1. Common name: Anti-cyclic citrullinated peptide (CCP) assayassay kit ( turbidimetric method )
  2. English name: Anti-cyclic citrullinated assaytest kit

(turbidimetry method)

Intended Use

This kit is used for the in vitro quantitative determination of anti-cyclic citrulline assay IgG content in human serum.

Anti-cyclic citrullinated peptide antibodies (CCP), a polypeptide fragment of cyclic polyserine, are IgG-based antibodies that are spontaneously secreted by B lymphocytes from patients with rheumatoid arthritis (RA), whereas B lymphocytes from patients with other diseases and the normal population do not spontaneously secrete anti-CCP antibodies. Therefore, anti-CCP antibodies have good sensitivity and specificity for rheumatoid arthritis.

Test Principle

The Keene principle used in this kit is the turbidimetric method. Anti-cyclic citrullinated peptide-bonded BSA is adsorbed on latex particles, and specific antibodies in diluted human serum are made to bind to the antigen by incubation, and the amount of absorbance change produced after incubation is proportional to the concentration of specific antibodies in the test sample.

Main Components

Reagent components included in the product.

Anti-Cyclic Citrullinated Peptide (CCP) Assay Kit & Bulk Reagents

*Components are not interchangeable in kits with different lot numbers.

*Reagent components not included in the product, but necessary for the test: outsourced normal and abnormal QCs and calibrators.

Storage Conditions And Expiration Date

The kit is stored at 2-8°C away from light and is valid for one year.

Reagents that have been opened are careful not to be contaminated, and reagents are stable in the instrument compartment (2-8°C) for one month.

The reagents must not be frozen.

Applicable Instruments

Hitachi 7180/7600; Olympus AU680/2700; Toshiba TBA120; Myriad BS2000M/480; Siemens ADVIA 1800/2400 series automatic biochemical analyzers.

Sample Request

  1. The samples are serum. Fresh samples can be stored at 2°C to 8°C for 4 days or frozen at -20°C for longer storage. Thawed samples can be thawed up to 3 times and thawed samples need to be well shaken before use. Microbial contamination can seriously affect sample quality and lead to erroneous results.

Avoid the use of severely lipemic, jaundiced, hemolyzed and contaminated specimens.

Test Method

  1. Reagent preparation: liquid reagents are ready to use out of the bottle.
  2. test conditions: (different parameters on the machine can be requested according to different testing instruments)

Anti-Cyclic Citrullinated Peptide (CCP) Assay Kit & Bulk Reagents

Operation steps.

Anti-Cyclic Citrullinated Peptide (CCP) Assay Kit & Bulk Reagents

Reagents and sample volumes can be increased or decreased in proportion to the requirements of different biochemical analyzers.

  1. Calibration procedure.

The use of matching calibrators is recommended.

  1. QC control procedures.

It is recommended that each laboratory establish its own quality control system and select appropriate quality control products for quality control. The measured values of QC products should be within the specified range. If outside the specified range, it is necessary to take appropriate measures or contact the manufacturer.

  1. Calculation.

Sample concentration = △A×calibrator concentration

Positive Judgment Value Or Reference Interval

0~35 AU/mL

It is recommended that each laboratory establish its own reference range of normal values.

Interpretation Of Test Results

Bilirubin ≤ 30mg/dL, hemoglobin ≤ 500mg/dL and celiac ≤ 500mg/dL will not interfere with this test.

Limitations Of The Test Method

The determination of CCP in human serum is only one of the indicators used by the clinician to make a diagnosis of the patient. The clinician must also make a comprehensive judgment based on the patient’s physical symptoms, medical history, and other diagnostic items and diagnostic tools.

 

Product Performance Indicators

Absorbance of reagent blank: wavelength 500 nm, optical diameter 1.0 cm, temperature 37°C, A0 ≤ 0.20.

Analytical sensitivity: the kit tests 25 U/mL of the test substance, the absorbance change value ΔA ≥ 0.002.

Linearity range: test serum samples, reagent linearity in the interval of 5 to 100 U/mL, linear correlation coefficient|r| should not be less than 0.990; in the interval of 5 to 25.0 U/mL, the absolute deviation of linearity should not exceed 3 U/mL; in the interval of (25.0 to 100 U/mL, the relative deviation of linearity should not exceed ±10%.

Precision: repeatability CV≤ 10.0%; relative extreme difference between batches≤ 10.0%.

Accuracy: Relative deviation ≤ 15%.

Caution

  1. This product is for in vitro diagnosis only.
  2. Avoid contamination when using the reagent, the container used must be clean, and please take necessary precautions, do not swallow, and avoid contact with skin and mucous membrane.
  3. Please dispose of the measured samples and waste liquids in accordance with the relevant national and local laws and regulations.
  4. When changing the reagent lot number, the calibration should be re-calibrated.
  5. Do not mix kits of different lot numbers and reagents left after use.

Reference

Clinical Laboratory Management and Technical Protocols” Lu Yongsui, Zhang Weiming

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