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    25.signal HIV Immuno Dot

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    prastachar
    This standard operating procedure outlines the protocol for using the SIGNAL HIV Flow through HIV 1+2 spot / Immunodot Test Kit to detect HIV antibodies in serum samples. The test detects antibodies that bind to immobilized antigens, producing a distinct pink dot. The procedure describes preparing samples and controls, performing the test, interpreting results as negative, positive or invalid, and addressing troubleshooting issues. It is the responsibility of the lab technician to test samples for HIV detection, document results, and properly dispose of samples according to biomedical waste guidelines.

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

    25.signal HIV Immuno Dot

    Uploaded by

    prastachar
    52 views5 pages
    This standard operating procedure outlines the protocol for using the SIGNAL HIV Flow through HIV 1+2 spot / Immunodot Test Kit to detect HIV antibodies in serum samples. The test detects antibodies that bind to immobilized antigens, producing a distinct pink dot. The procedure describes preparing samples and controls, performing the test, interpreting results as negative, positive or invalid, and addressing troubleshooting issues. It is the responsibility of the lab technician to test samples for HIV detection, document results, and properly dispose of samples according to biomedical waste guidelines.

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    25.Signal HIV Immuno Dot.docx

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    This standard operating procedure outlines the protocol for using the SIGNAL HIV Flow through HIV 1+2 spot / Immunodot Test Kit to detect HIV antibodies in serum samples. The test detects antibodies that bind to immobilized antigens, producing a distinct pink dot. The procedure describes preparing samples and controls, performing the test, interpreting results as negative, positive or invalid, and addressing troubleshooting issues. It is the responsibility of the lab technician to test samples for HIV detection, document results, and properly dispose of samples according to biomedical waste guidelines.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    52 views5 pages

    25.signal HIV Immuno Dot

    Uploaded by

    prastachar
    This standard operating procedure outlines the protocol for using the SIGNAL HIV Flow through HIV 1+2 spot / Immunodot Test Kit to detect HIV antibodies in serum samples. The test detects antibodies that bind to immobilized antigens, producing a distinct pink dot. The procedure describes preparing samples and controls, performing the test, interpreting results as negative, positive or invalid, and addressing troubleshooting issues. It is the responsibility of the lab technician to test samples for HIV detection, document results, and properly dispose of samples according to biomedical waste guidelines.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    of 5

    KAPVGMC MICROBIOLOGY LABORATORY STANDARD OPERATING PROCEDURE

    (KML)
    K.A.P. Viswanatham Government Medical SIGNAL HIV (IMMUNO DOT)
    college
    Tiruchirappalli – 620 001. Issued date : 01.01.2019

    1.0 OBJECTIVE:
    To describes the procedure for carrying out the SIGNAL HIV Flow through HIV 1+2
    spot / Immunodot Test Kit, manufactured by Span diagnostics Ltd.,

    2.0 SCOPE:
    This standard operating procedure contains the procedure to be adopted for detection of
    HIV 1 & 2 antibodies using SIGNAL HIV Flow through HIV 1+2 spot / Immunodot Test
    Kit.

    3.0 Principle:
    The SIGNAL HIV Flow through HIV 1+2 spot / Immunodot Test Kit detects HIV
    antibodies in the serum which bind to immobilized antigens on a porous immunofiltration
    membrane to give a distinct pinkish purple dot.

    4.0 RESPONSIBILITY:
    It is responsibility of the lab technician to:
     Testing the blood sample for HIV antibody detection in the lab.
     Entering the details in the respective documents.
     Ensuring rejected samples are discarded properly.

    5.0 DESIGNATED AREA:


    Workbench of the SRL, Department of Microbiology, KAPVGMC, TIRUCHY .

    6.0 DEFIINITIONS:
    Negative control serum: Negative for HIV antibodies supplied by the manufacturer.
    Positive control serum: Positive for HIV antibodies supplied by the manufacturer
    External Quality control: Sample previously received and tested in the HIVTL/SRL.

    Document Type : Standard Operating Procedure Issue No. : 11


    Document No. : MICRO/KAPVGMC/SOP-SRL 25 Issue Date : 01.01.2019
    Amendment No. : 00 Page No. :Page 1 of 5
    Prepared by Reviewed by Approved by
    KAPVGMC MICROBIOLOGY LABORATORY STANDARD OPERATING PROCEDURE
    (KML)
    K.A.P. Viswanatham Government Medical SIGNAL HIV (IMMUNO DOT)
    college
    Tiruchirappalli – 620 001. Issued date : 01.01.2019

    7.0 MATERIALS REQUIRED:


    EQUIPMENTS CONSUMABLES REGISTERS
     Refrigerator with freezer  Tissue paper  Lab register
     Micro pipette (20- 200ul)  Disposable gloves  Stock register
     Timer  Spirit & Cotton,  Work sheet
     Discarding bin with 1% Sodium
    hypo chlorite
     Pipettes Tips (200 ul-1000 ul)
     Water
     SIGNAL HIV Flow through HIV
    1+2 spot / Immunodot Test Kit
     Marker pen
    8.0 KIT COMPONENTS:
     SIGNAL HIV Flow through HIV 1+2 spot / Immunodot Test Kit
     Buffer solution
     Gold conjugate
     10ul dropper
     Controls

    9.0 STORAGE:
     SIGNAL HIV Flow through HIV 1+2 spot / Immunodot Test Kit should be stored in
    Refrigerator at 2 - 8oC.
    10.0 TEST PROCEDURE:
    Do not open pouch until you are ready to test the sample.
     Universal precautions are strictly followed during the procedure.
     Prepare a sample work sheet as per the samples received

    Document Type : Standard Operating Procedure Issue No. : 11


    Document No. : MICRO/KAPVGMC/SOP-SRL 25 Issue Date : 01.01.2019
    Amendment No. : 00 Page No. :Page 2 of 5
    Prepared by Reviewed by Approved by
    KAPVGMC MICROBIOLOGY LABORATORY STANDARD OPERATING PROCEDURE
    (KML)
    K.A.P. Viswanatham Government Medical SIGNAL HIV (IMMUNO DOT)
    college
    Tiruchirappalli – 620 001. Issued date : 01.01.2019

     Take HIV Kit from refrigerator and leave in room temperature for 30 minutes before
    testing.
     Bring all reagents and specimens to room temperature.
     Take required number of testing devices according to number of samples and controls to
    be tested.
     Remove the test device from the foil pouch and place on a clean dry surface.
     Label the device with the control and sample PID numbers using a permanent marker.
     Place the devices on a flat surface.
     Add 2 drops of wash buffer solution to the well in the device.
     Add 1 drop of Test samples, negative and positive controls provided by the manufacturer
    and a EQC sample previously received and tested by the laboratory should be added to
    the test devices respectively.
     Use separate dropper for each sample.
     Add 2 drops of wash buffer solution to the well.
     Add 2 drops of signal reagent to the well.
     Add 3 drops of wash buffer solution.
     Record results within next 10 minutes.
     The materials and samples used in the procedure are discarded as per the biomedical
    waste management guidelines.
    11.0 INTERPRETATION OF RESULTS:
     Non-reactive: Only the control dot appears on the membrane. The absence of a test dots
    at test region indicates a negative result.
     Reactive: Control dot and dot appearing on test region indicates positive result for HIV
    1 &/ 2.
     Invalid Result: Absence of pinkish red dot at control “C” region with presence or
    absence of dot at test “T” region indicates invalid result.
     Repeat the test using a new test device.
     Validity of the test:
    Document Type : Standard Operating Procedure Issue No. : 11
    Document No. : MICRO/KAPVGMC/SOP-SRL 25 Issue Date : 01.01.2019
    Amendment No. : 00 Page No. :Page 3 of 5
    Prepared by Reviewed by Approved by
    KAPVGMC MICROBIOLOGY LABORATORY STANDARD OPERATING PROCEDURE
    (KML)
    K.A.P. Viswanatham Government Medical SIGNAL HIV (IMMUNO DOT)
    college
    Tiruchirappalli – 620 001. Issued date : 01.01.2019

     The validity of this test is dependent on the results obtained with the positive and negative
    controls used in the test.
     Positive control should give a dot at ‘C’ along with dots at ‘T’ region.
     Negative control should give a dot only at ‘C’.

    Note: The readings of all tests should be recorded by a minimum of two individuals. Weakly
    reactive samples require adequate natural lighting for proper interpretation and should
    therefore be read with appropriate lighting in the laboratory.

    12.0 TROUBLE SHOOTING:


    PROBLEM REASON SOLUTION
    1. Flooding of sample  Adding more drops of  Add only as per the given
    buffer or conjugate. procedure.
    2. Weak intensity of  Very cold reagent  Bring the sample and buffer and
    control line conjugate to room temperature if
    stored lower temperature.
    3. Poor sensitivity or weak  Frozen sample not mixed  Mix the sample well and
    intensity of test and properly after thawing. centrifuge to remove particulate
    control lines. matter before pipetting.
    4. Half dot seen  Sample insufficiently added  Add sufficient volume.

    13.0 REFERENCES:
     Kit Insert – SIGNAL HIV Flow through HIV 1+2 spot / Immunodot Test Kit,
    manufactured by Span diagnostics Ltd.,
     National Guidelines on HIV testing, Ministry of Health and family Welfare, National
    AIDS Control Organization, March 2007 & July 2015
     Manual on Quality Standards for HIV Testing Laboratories, Ministry of Health and
    family Welfare, National AIDS Control Organization, March 2007.
     National Guidelines on Quality Management Systems in HIV Testing Laboratories,
    Ministry of Health and family Welfare, National AIDS Control Organization, July 2015.

    Document Type : Standard Operating Procedure Issue No. : 11


    Document No. : MICRO/KAPVGMC/SOP-SRL 25 Issue Date : 01.01.2019
    Amendment No. : 00 Page No. :Page 4 of 5
    Prepared by Reviewed by Approved by
    KAPVGMC MICROBIOLOGY LABORATORY STANDARD OPERATING PROCEDURE
    (KML)
    K.A.P. Viswanatham Government Medical SIGNAL HIV (IMMUNO DOT)
    college
    Tiruchirappalli – 620 001. Issued date : 01.01.2019

    Document Type : Standard Operating Procedure Issue No. : 11


    Document No. : MICRO/KAPVGMC/SOP-SRL 25 Issue Date : 01.01.2019
    Amendment No. : 00 Page No. :Page 5 of 5
    Prepared by Reviewed by Approved by

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