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    Agappe Diagnostics LTD.: 10 Tests 12014034

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    micklemagdy50
    This document provides instructions for using a test to quantify the complement C3 protein in human serum or plasma samples. The test uses nephelometry methodology in pre-filled cartridges to directly measure C3 concentration. Clinical significance and principles are described. The procedure, references ranges, and performance characteristics are also outlined.

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    Agappe Diagnostics LTD.: 10 Tests 12014034

    Uploaded by

    micklemagdy50
    42 views2 pages
    This document provides instructions for using a test to quantify the complement C3 protein in human serum or plasma samples. The test uses nephelometry methodology in pre-filled cartridges to directly measure C3 concentration. Clinical significance and principles are described. The procedure, references ranges, and performance characteristics are also outlined.

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    12014034

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    This document provides instructions for using a test to quantify the complement C3 protein in human serum or plasma samples. The test uses nephelometry methodology in pre-filled cartridges to directly measure C3 concentration. Clinical significance and principles are described. The procedure, references ranges, and performance characteristics are also outlined.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    42 views2 pages

    Agappe Diagnostics LTD.: 10 Tests 12014034

    Uploaded by

    micklemagdy50
    This document provides instructions for using a test to quantify the complement C3 protein in human serum or plasma samples. The test uses nephelometry methodology in pre-filled cartridges to directly measure C3 concentration. Clinical significance and principles are described. The procedure, references ranges, and performance characteristics are also outlined.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 2

    10 Tests

    C3 12014034

    Intended Use Sample


    This reagent is intended for the in vitro quantitative determination of complement Fresh serum or plasma. (Do not use lipemic or hemolysed sample).
    C3 in human.
    Interferences
    -Nephelometry methodology No interference for
    -Linear up to 400 mg/dL Bilirubin up to 20 mg/dL
    - Ready to use cartridges Haemoglobin up to 1000 mg/dL
    -No calibration required
    Triglycerides up to 2500 mg/dL
    -Lower Detection Limit of 14 mg/dL
    Materials provided
    Clinical Significance
    C3 Test Cartridges – 10 nos.
    C3 component is the central point of classic and alternative compliment
    pathway.Compliment testing helps to diagnose the cause of recurrent microbial IC Card with Calibration Data - 1 no.
    infections,angioedema ,inflammation and in acute or chronic autoimmune disease
    such as Systemic Lupus Erythematosus(SLE).Decreased levels of C3 are significant Procedure
    in autoimmune disease, recurrent infections with pyrogenic bacteria, neonatal RDS The test details and the calibration data is provided in the smart card along with
    and congenital deficiencies. C3 behaves as an acute phase protein hence increased the kit.
    levels may found in acute inflammatory reactions.
    • Insert the test card in to card reader slot.
    Principle • Select test function from the main screen and allow the carrier to slide out of
    The serum sample reacts upon specific antibody for human complement C3 and equipment.
    cause change in absorbance which is directly proportional to concentration of C3
    in the sample. • Take one pre-fil led cartridge of C3 and tap gently before adding the sample
    to remove air bubbles if any.
    Reagent Composition
    C3 Cartridge • Add 80 µL of sample to the dedicated well in the cartridge. (Well No. 6) and
    place in the cartridge carrier. Select the OK button in the equipment.
    Reagent Wel l Description • Cartridge slides into the equipment, and gets detected for the test. If not detected
    equipment wil l make two additional attempts. On successful detection of
    C3 R1 Well No. 3 PBS (pH 7.43)
    cartridge the display shows the corresponding test name with calibration details.
    Polyethylene glycol 60 g/L
    Select ‘Save’ button to save the calibration of corresponding test in to the
    C3 R2 Well No. 4 Polyclonal goat anti-human analyzer.
    C3 antibodies • Select “OK” to conform the calibration data and for entering patient demographic
    Diluent R3 Well No:2 Normal Saline details.

    Note: Wells are numbered consecutively from the reaction cell end of the cartridge.
    • Enter the patient demographic details and select the ‘START’ button to run the
    test. Status updates along with progress bar will be shown during the test.
    (Well No. 1) Refer figure No. 1
    Risk & safety
    • After analyzing the sample, the test results will be printed as well as displayed
    on the screen.
    Material safety data sheets (MSDS) will be provided on request.
    • The equipment will eject the cartridge carrier for removing the used cartridge.
    Reagent Preparation Remove the cartridge, press “EXIT” and select “Ok” to proceed further for next
    test or select ‘HOME’ for the main menu.
    Reagents are ready to use and supplied in prefilled cartridges.
    Pipetting, dispensing and mixing are automatically performed by the instrument. Note: Once the calibration of particular test is saved in to analyzer, test can be
    performed without inserting smart card in to the analyzer, until and unless
    Reagent Storage and Stability calibration in the analyzer expires or no more test left in the Saved card.
    The sealed cartridges are stable up to the expiry date stated on the kit label, when Quality Control
    stored at 2- 80C and protected from light. DO NOT FREEZE.
    It is recommended to use control to verify the performance of the assay. Each
    Reagent Deterioration laboratory has to establish its own internal quality control scheme and procedure
    Turbidity or precipitation in any cartridge component indicates deterioration and for corrective action, if control do not recover within the acceptable range.
    the cartridge must be discarded. Values outside the recommended acceptable range
    for the Agappe Protein control may also be an indication of reagent instability
    Reference Range
    and associated results are invalid. Sample should be retested using fresh Cartridge. It is recommended that each laboratory establish its own reference values.
    The following value may be used as guide line.
    Precaution Adults: 90 - 180 mg/dL
    1. To avoid contamination use clean laboratory wares. Use clean dry disposable
    pipette tips for dispensing sample. Results obtained for patient samples are to be correlated with clinical findings of
    the patient for interpretation and diagnosis.
    2. Avoid direct exposure of cartridge to light. Al low the cartridge to attain room
    temperature before performing the test. Performance Characteristics
    3. Avoid reuse of sample from used cartridges.
    1. Linearity
    4. Before performing the test ensure that reagents are not sticked to the
    seal ing, if so tap the cartridge gently to get it down to the bottom of the The reagent is linear up to 400 mg/dL. If the concentration is greater than linearity,
    wel l. dilute the sample with normal saline and repeat the assay. Multiply the result
    5. Avoid air bubbles in the cartridge before test. with dilution factor.
    6. Clean the exterior of the reaction cel l (Wel l No.1) with dry tissue paper 2. Comparison
    before load ing in the cartridge carrier.
    A comparison study has been performed between Mispa i3 C3 and other
    7. Ensure the reaction cell is dust free and moisture free. internationally available reagent yielded a correlation coefficient of r2 = 0.955 and
    Note: Used cartridge contain human bodyfluids, which can be potential ly bio a regression equation of y =0.9248x +9.23
    hazardous, handle with appropriate care to avoid skin contact and ingestion.
    Waste Management
    Cartridges must be disposed off in accordance with local regulations.

    SYMBOLS USED ON THE LABELS

    IN VITRO DIAGNOSTIC USE SEE PACKAGE INSERT FOR PROCEDURE LOT NUMBER MANUFACTURER’S ADDRESS MANUFACTURING DATE EXPIRY DATE TEMPERATURE LIMIT

    AGAPPE DIAGNOSTICS LTD.


    ‘Agappe Hills’, Dist. Ernakulam, Kerala, India-683 562.
    Tel. +91 484 2867 000 | Customer Support No.: 1800 425 7151(Toll Free) ISO 9001 : 2015
    [email protected] | www.agappe.com REV. NO.: ADL/IFU/C3/I3/R01 EN ISO 13485 : 2016
    10 Tests
    C3 12014034

    3. Precision
    Accuracy (mg/dL)
    Intra Run
    Control Expected Value Measured Value
    Control Level 1 Control Level 3
    Control Level 1 83 ± 13.4 83.72
    n 20 20
    Mean (mg/dL) 95.13 226.77 Control Level 3 268 ± 48 269.93
    SD 3.9 8.1
    4. Sensitivity
    CV(%) 4.13 3.60 Lower detection limit: 14 mg/dL.

    Inter Run Bibliography


    Control Level 1 Control Level 3 1. Bergstrom, K. &Lefvert, A.K. Scand. J. Clin. Lab. Inest. 40 (1980), 637.

    n 20 20 2. Tietz, Text book of Clinical Chemistry, W. B. Saunders, Philadelphia, (1994)


    Mean (mg/dL) 78.39 269.28 3. Roitt, I., Essential Immunology, Blackwell, Oxford, (1991)
    SD 6.91 16.96
    4. Dati, F. et al., Lab. Med. 13, 87 (1989)
    CV(%) 8.82 6.30
    5. Muller-Eberhard, H. H., Ann. Rev. Biochem. 44, 697 (1975)
    6. Lachmann, P. J.,Hobart, M. J., and Ashton, W.P., (1973) in Hand book of
    ExperimentalImmunology, 2nd Ed, 16, Ed. D. M. Weir, Blackwel l Scientific
    Publications

    The calibration data is incorporated in the smart card.


    Hence no calibration is required.

    Cartridge Image ( Figure No. 1)

    SYMBOLS USED ON THE LABELS

    IN VITRO DIAGNOSTIC USE SEE PACKAGE INSERT FOR PROCEDURE LOT NUMBER MANUFACTURER’S ADDRESS MANUFACTURING DATE EXPIRY DATE TEMPERATURE LIMIT

    AGAPPE DIAGNOSTICS LTD.


    ‘Agappe Hills’, Dist. Ernakulam, Kerala, India-683 562.
    Tel. +91 484 2867 000 | Customer Support No.: 1800 425 7151(Toll Free) ISO 9001 : 2015
    [email protected] | www.agappe.com REV. NO.: ADL/IFU/C3/I3/R01 EN ISO 13485 : 2016

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