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    Cea Wondfo 2273 PDF

    Uploaded by

    Aracely Trejo
    1) The document provides instructions for using the FinecareTM FIA System to perform a CEA test on a blood sample. 2) Key steps include loading 75uL of sample mixture into the test cartridge, inserting the cartridge into the system, and reading the results on the screen in ng/mL. 3) The test is intended for human whole blood, serum, and plasma samples only and results must be evaluated with other clinical data.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd

    Cea Wondfo 2273 PDF

    Uploaded by

    Aracely Trejo
    111 views1 page
    1) The document provides instructions for using the FinecareTM FIA System to perform a CEA test on a blood sample. 2) Key steps include loading 75uL of sample mixture into the test cartridge, inserting the cartridge into the system, and reading the results on the screen in ng/mL. 3) The test is intended for human whole blood, serum, and plasma samples only and results must be evaluated with other clinical data.

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    CEA WONDFO 2273.pdf

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    1) The document provides instructions for using the FinecareTM FIA System to perform a CEA test on a blood sample. 2) Key steps include loading 75uL of sample mixture into the test cartridge, inserting the cartridge into the system, and reading the results on the screen in ng/mL. 3) The test is intended for human whole blood, serum, and plasma samples only and results must be evaluated with other clinical data.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    111 views1 page

    Cea Wondfo 2273 PDF

    Uploaded by

    Aracely Trejo
    1) The document provides instructions for using the FinecareTM FIA System to perform a CEA test on a blood sample. 2) Key steps include loading 75uL of sample mixture into the test cartridge, inserting the cartridge into the system, and reading the results on the screen in ng/mL. 3) The test is intended for human whole blood, serum, and plasma samples only and results must be evaluated with other clinical data.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 1

    Pipette 75 uL of sampie mixture and Ioad it into the sample we= of the Test System indicating that the

    that the test should be repeated,


    Ca軸dge,
    Sfep 5:わs帥g
    丁here a「e two test modes fo「 FinecareTM FiA System, Standard Test mode and

    Qujck Test mode・ PIease 「efe「 to the Ope「atjon Manual of FinecareTM FIA System 1" This test has been developed for testing human whoie blood, Serum, Plasma
    fo「 details, SPeCimen only.
    a) For Standard Test mode: lnsert the Test Cartridge onto the Test Ca軸dge 2. The test p「ocedu「e, P「eCautions and inte「pretations of resuIts fo「 this test must

    holder of FinecareTM FIA System 「ight a債er adding samp看e mixture to the be fd川owed when testing.

    SamPle weil・ P「ess “Test’’to sta巾testing, (Apply to FS-112, FS-113 and 3. The 「esuits of FinecareTM CEA Rapid Quantitatjve Test should be evaluated with
    FS-205) a= avaiIabIe cIinicai and Iaboratory data.
    b) For Quick Test mode: Set the time「 and count down 「ight after adding 4"丁he faise positive resuits incIude cross-「eaCtions with some components of

    SamPle mixtu「e into the sampIe well and leave it at room temperatu「e for 15 Serum f「om individua=o antibodies; and non-SPeC肺c adhesion of some
    minutes・丁hen insert the Test Ca軸dge ohto the Test Ca輔dge hoide「 of COmPOnentS in human bIood that have similar epitopes to capture and detecto「

    FinecareTM FIA System. P「ess “Test” to starf testing" Fineca「eTM FiA antibodies・ in the case of false negative 「esults, the most common facto「s are:

    System wi= start scaming the sampie-ioaded Test Ca輔dge immediately・ non-「eSPOnSiveness of antigen to the antibodies by that certain unknown

    (Apply to FS-112 and FS-113) COmPOnentS a「e maSking its epitope, SuCh that antigen camot be seen by the
    Results a「e displayed on main sc「een o「 be p「inted by press “Print,,, antibodies; instab冊y of CEA antigen, reSuIting in degradation with time and, O「
    Discard the used Test Ca輔dge according to Iocal reguIations and procedu「es temperatureタSuCh that they become no Ionger recognjzable by antibodies; and
    after released f「om Fineca「eTM FIA System" deg「aded othe「 test components. The effectiveness of the tes=s highIy

    dependent on storage of kits and sampIe specimens at optimai conditions.


    5・ Other facto「s may interfe「e with FinecareTM CEA Rapid Quantjtative Test and

    may cause erroneous results" These incIude technicai o「 p「ocedurai e「rors, aS


    丁he Fineca「eTM FiA System caIculates CEA test resuits automatica=y and disp-ays We= as additional substances in blood specimens.
    the exact concentrations of CEA on the sc「een as fo「m of XXX.X ng/mL. For

    fu而he「 information, Please 「efer to the Operation Manuai fo「 the Fineca「eTM FiA

    System.

    Normai reference vaiue‥ ≦5.O ng/mL

    A compa「ative study is tested for 223 clinicai sampIes in using FinecareTM CEA
    Note: Recommend that each音aboratory formulates its own refe「ence range Rapid Quantitative Test and the Roche CEA Reagent Kit.
    according to actual situation。 The Co「「elation Coe冊cient (R2) is O.979,

    Each Fineca「eTM CEA Rapid Quantitative Test Ca軸dge contains intemai control ● Assay Range: 1-500 ng/m」
    that satjsfies routine quality controI 「equirements. This inte「nai controI is ● Detection Limit (AnaIytical Sensitivity): 1 ng/m」

    Pe巾)rmed each time when a patient sample is tested, This contro=ndicates that
    the Test Ca軸dge was inserfed and read prope「ly by FinecareTM FIA System" An

    invaIid resuIt f「om the inte「nai controI causes an e「「o「 message on FinecareTM FIA

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