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    Laporan Immun II Lagi

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    ashaarul97
    This document summarizes the instructions and procedures for using the Dengue IgM and/or IgG Rapid Test Cassette. When a specimen is added to the test, IgG and IgM antibodies in the sample react with gold particles labeled with dengue envelope proteins. As the specimen/particle mixture migrates along the test, anti-dengue IgG and/or IgM antibody complexes are captured, forming lines that indicate positive or negative results. A control line should always appear to verify proper performance. The test is used to detect dengue antibodies in serum or plasma samples.

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    Laporan Immun II Lagi

    Uploaded by

    ashaarul97
    19 views6 pages
    This document summarizes the instructions and procedures for using the Dengue IgM and/or IgG Rapid Test Cassette. When a specimen is added to the test, IgG and IgM antibodies in the sample react with gold particles labeled with dengue envelope proteins. As the specimen/particle mixture migrates along the test, anti-dengue IgG and/or IgM antibody complexes are captured, forming lines that indicate positive or negative results. A control line should always appear to verify proper performance. The test is used to detect dengue antibodies in serum or plasma samples.

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    This document summarizes the instructions and procedures for using the Dengue IgM and/or IgG Rapid Test Cassette. When a specimen is added to the test, IgG and IgM antibodies in the sample react with gold particles labeled with dengue envelope proteins. As the specimen/particle mixture migrates along the test, anti-dengue IgG and/or IgM antibody complexes are captured, forming lines that indicate positive or negative results. A control line should always appear to verify proper performance. The test is used to detect dengue antibodies in serum or plasma samples.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    19 views6 pages

    Laporan Immun II Lagi

    Uploaded by

    ashaarul97
    This document summarizes the instructions and procedures for using the Dengue IgM and/or IgG Rapid Test Cassette. When a specimen is added to the test, IgG and IgM antibodies in the sample react with gold particles labeled with dengue envelope proteins. As the specimen/particle mixture migrates along the test, anti-dengue IgG and/or IgM antibody complexes are captured, forming lines that indicate positive or negative results. A control line should always appear to verify proper performance. The test is used to detect dengue antibodies in serum or plasma samples.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    of 6

    LAPORAN IMUNOSEROLOGI II

    Dengue IgM and/or IgG Rapid Test Cassette

    OLEH:
    Annisa Shafa Azzahra
    PO714203221052

    DOSEN PEMBIMBING
    Nurdin, S.Si., M.Kes
    Besse Uswatun Hasanah, S.Tr. Kes

    POLTEKKES KEMENKES MAKASSAR


    SARJANA TERAPAN TEKNOLOGI LABORATORIUM MEDIS
    2024
    Dengu IgM and/ or IgG Rapid Test Cassette
    (Serum/Plasma)

    INTRODUCTION
    Dengue IgM and/or IgG Rapid Test Cassette is a lateral flow chromatographic immunoassay for
    the simultaneous detection and differentiation of IgM and IgG anti-dengue in human serum (or
    plasma). The Kit is a diagnostic device for qualitative detection.

    SUMMARY
    When a specimen is added to the test, IgG and IgM antibodies in the specimen sample react with
    gold particles labled with dengue envelope proteins. As this specimen/particle mixture migrates
    along the length of the test, the anti-dengue IgG and/or IgM antibody particle complex is
    captured by the relevant IgG and IgM test bands located in the test device window causing a pale
    to dark red band to form at the test region of the cassette window. The intensity pf the bands will
    vary depending upon the amount of antibody present in the sample. The appearance of any color
    in test region should be considered as positive for IgG and/or IgM antibody. A red procedural
    control line should always develop in the test device window to indicate that the test has been
    performed properly.

    SPECIMEN COLLECTION
    For serum or plasma, collect blood into a container without anticoagulant. If the specimen cannot
    be tested on the day of collection, store the serum or plasma specimen in a refrigerator or freezer.
    Bring the speciments to room temperature before testing.
    TEST PROCEDURE
    1. Open a pouch containing a cassette, remove the test kit from the pouch and place it
    horizontally on the desk.
    2. Dilute the specimen 10 times with diluent(e.g. Pipette 1 drop about 5ul of specimen into the
    same well and then add 1 drop about 50ul of diluent into the same well).
    3. Read results within 15 minutes. Do not read results after 20 minutes.

    INTERPRETATION OF RESULTS
    Negative: Only control pink band appears on the membrane of the cassette. This indicates that
    there is no anti-dengue IgM and IgG in the specimen.
    Positive: Three pink bands(C,G,M) , two pink bands(C,G) or (C,M) appear on test region of the
    cassette. This indicates that the specimen contains detectable amount of anti-dengue IgG and
    IgM, only IgG, only IgM.
    'Invalid: If without colored band appears at control region, this is an indication of a possible
    error in performing the test.
    The test should be repeated using a new one.

    PRECAUTION
    1.Must use fresh specimen and avoid repetitive freezing, the result will be invalid.
    2.Use it before expiry date.
    3. The package of kit should not be opened until it reaches the room temperature if it taken out
    from the refrigerator. Use the test kit as soon as possible but within 1 hour after removal from
    pouch specially if the room temperature is more than 30C and in high humidity environment.
    4.Old serum can not be used. If the serum is thick, it can be used only after being separated.

    LIMITATIONS
    1.The test is for in-vitro diagnostic use only.
    2. The test is qualitative fitter detection, it can not be used as the final test for blood donor.
    STORAGE AND STABILITY
    The test kit can be stored at room temperature ( 4 to 30°C) in the sealed pouch to the date of
    expiration. The test kit should be kept away from direct sunlight, moisture and heat.
    INTERPRETATION OF RESULTS

    Positive: Two lines appear. One colored line should be in the control line region (C) and another
    apparent colored line should be in the test line region (T).
    Negative: One colored line appears in the control line
    INVALID region(C). No line appears in the test line region (T).
    Invalid: Control line fails to appear

    QUALITY CONTROL
    The control line in the control zone is a built-in procedural control in the Test. The control line
    appearing as specified indicates that the test is properly performed and reagents are functional.
    Controls standards are not supplied with this kit; however it is recommended that positive and
    negative controls be tested as a good laboratory practice to confirm the test procedure and to
    verify proper test performance.
    LIMITATIONS
    1. The Test is for in vitro diagnostic use only.
    2. The Test is a qualitative test.
    3. The test is an aid to clinical diagnosis of HIV infection. As with all diagnostic tests, however,
    result from the Test should not be used as the only basis for a screen diagnosis.
    4. The test result should be interpreted together with all other clinical and laboratory findings by
    a physician before a definite diagnosis can be reached.
    5. The positive results should be confirmed by independent confirmatory tests.
    6. In cases where the test result is negative while clinical symptoms persist, further consultation
    with a physician and additional tests of other methods should be followed. A negative result at
    any time does not preclude the possibility of HIV -1 and/or -2 infection.
    PERFORMANCE CHARACTERISTICS
    Sensitivity: The test has been compared with a leading commercial HIV ElA test using clinical
    specimens. Results showed the HIV rapid device is very sensitive to HIV 1 and/or HIV 2
    antibodies.
    Specificity: The specificity is comparable to a leading commercial HIV EIA test. The test is
    highly specific for anti-HIV-1 and/or -2 when compared to a leading commercial HIV ElA test.
    The HIV One Step Rapid Test vs. ElA test

    Relative sensitivity : 99.5%


    Relative specificity : 99.8%
    Accuracy : 99.7%
    REFERRENCE
    1. Janssen, RS, Satten, GA, Stramer, SL, Rawal, BD, O'Brien, TR, Weiblen, BJ, Hecht, FM,Jack,
    N, Cleghorn, FR, Kahn, JO, Cheney, MA and Busch MP. New testing strategy to detect earl
    HIV-1 infection for use in incidence estimates and for clinical and prevention purposes. JAMA
    (1998) 280(1): 42-48.
    2. Vasudevachari M.B., et al. Principles and Procedures of Human Immunodeficiency Virus
    Serodiagnosis. In Noel
    R. Rose, et al. (ed.), Manual of Clinical Laboratory Immunology. P. (1997) 788-801. ASM Press.
    Wash. D.C.
    INDEX OF SYMBOLS
    VALIDITY SHEET

    Makassar, 18 February, 2024


    Praktikan

    Annisa Shafa Azzahra

    Dosen Pembimbing

    Pembimbing I Pembimbing II

    Nurdin, S.Si., M.Kes Besse Uswatun Hasanah, S.Tr. Kes

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