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    Serology - MRL - Infection - RCRL

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    Rashed Lab
    1. To validate test results, check that testing kits, controls, procedures, and QC samples are within the specified acceptable ranges as outlined by the manufacturer. If all validation criteria are met, the test run is considered valid. 2. To interpret results, compare sample readings to the cutoff value. Ratios above the cutoff are initially reactive while ratios below are non-reactive. Some assays use a gray zone to classify borderline results. 3. Proper hand hygiene and use of personal protective equipment like face masks are important for infection control in medical laboratories. Hands should be washed before and after procedures, and masks should fully cover the

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    Serology - MRL - Infection - RCRL

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    Rashed Lab
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    1. To validate test results, check that testing kits, controls, procedures, and QC samples are within the specified acceptable ranges as outlined by the manufacturer. If all validation criteria are met, the test run is considered valid. 2. To interpret results, compare sample readings to the cutoff value. Ratios above the cutoff are initially reactive while ratios below are non-reactive. Some assays use a gray zone to classify borderline results. 3. Proper hand hygiene and use of personal protective equipment like face masks are important for infection control in medical laboratories. Hands should be washed before and after procedures, and masks should fully cover the

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    serology- Mrl - Infection- RCRL

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    1. To validate test results, check that testing kits, controls, procedures, and QC samples are within the specified acceptable ranges as outlined by the manufacturer. If all validation criteria are met, the test run is considered valid. 2. To interpret results, compare sample readings to the cutoff value. Ratios above the cutoff are initially reactive while ratios below are non-reactive. Some assays use a gray zone to classify borderline results. 3. Proper hand hygiene and use of personal protective equipment like face masks are important for infection control in medical laboratories. Hands should be washed before and after procedures, and masks should fully cover the

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    14 views12 pages

    Serology - MRL - Infection - RCRL

    Uploaded by

    Rashed Lab
    1. To validate test results, check that testing kits, controls, procedures, and QC samples are within the specified acceptable ranges as outlined by the manufacturer. If all validation criteria are met, the test run is considered valid. 2. To interpret results, compare sample readings to the cutoff value. Ratios above the cutoff are initially reactive while ratios below are non-reactive. Some assays use a gray zone to classify borderline results. 3. Proper hand hygiene and use of personal protective equipment like face masks are important for infection control in medical laboratories. Hands should be washed before and after procedures, and masks should fully cover the

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    Serology

    Station 1)
    You are given the result sheet of chemilumences ( controls sheet or sample result, architec , vitrus )
    Q1: How can you validate test results?
    A1: by 1) checking the testing kit validity by expiry date - last opening date and condition of storage) all
    according to manufacturer instructions.
    Checking the test procedure by
    A) check maintenance sheet to be sure status of device is working properly
    B) Controls are within accepted range
    e.g syphilis negative control : 0.035 and range ( -0.294 to 0. 294 ) so syphilis negative control is accepted
    Syphilis positive control is : 2.706 and rang (1.916 - 3.944) so syphilis positive control is accepted.
    Check the kit performance by QC sample results within the accepted range (LCL - UCL ) provided from
    MRL.
    After checking all previous steps and parameters are accepted the conclusion is RUN IS VALID
    2) The check sample results:
    If sample ratio (sample OD/cut-off) > 1 ===> initially reactive
    Applying gray zone if sample ratio (HCV 0.8 - 1.0 } or (HBV , HIV, $ 0.9 - 1.0 ) result is INITIALLY REACTIVE
    if sample < 0.8 in case of HCV ab and < 0.9 in case of HBsAg , HIV , syphilis Ab So ===> NON REACTIVE
    initial serology screening
    Non- reactive initially reactive
    sample to be repeated in
    DUPLICATE, SAME (sample-technique)
    Result is Non reactive

    Both NR -,- One R & One NR - , + both R +,+


    Send sample for NAT
    Result reported as Reactive
    Discard blood unit and all its related components
    You are give a NAT result sheet :

    Q1: how to Validate the given results


    A1: By A) checking the testing kit validity by Expiration date and storage condition
    B) Checking the test procedure by Device validity
    (maintenance sheet checked at proper time schedule
    C) Check Calibrators (controls) ===> negative & positive controls should be valid
    When all above criteria are accepted so ===> RUN IS VALID
    D) Check the sample result : Note ( NAT cut off = 1, and sample ratio = (sample OD/cut-off)
    Sample ratio > 1 =====> Reactive Sample ratio < 1 =====> Non- Reactive

    Q2: How to interpret the obtained results?


    A1: if initial serology screening test is NON_REACTIVE ==> perform NAT screening
    when NAT result is non reactive ==> Release blood units and all related components for issuing.
    * NAT is Initially Reactive is pooled NAT perform discriminatory NAT , the release result.
    Other wise Report result as Positive for NAT ==> Discard blood units and all its related components
    & permanent defer the donor from donation pool.

    Questions on station 1 and 2


    Q1: what are the types of NAT
    A1: PCR & TMA , PCR (polymerase chain reaction) , TMA (transcription mediated amplification)
    Q2:what are enzymes used in TMA NAT?
    A2: RT( reverse transcriptase) , RNAP (RNA polymerase)
    Q3: define ( NAT yield ) and (serology yield )
    A3: NAT yield means tested sample is reactive with NAT while Non reactive with serology screening
    Serology yield means tested sample is reactive by serology screening but non-reactive by NAT.
    Q4: what is window period and how NAT helps to minimize it?
    A4: window period is the time from infection to test reactivity
    NAT minimize it as follow : C, B, HIV, = 7, 8, 9.

    Station 3
    How to validate blood grouping results for donors?
    By 1) checking the kits expiration date , date of last usage and storage condition
    Including : ( blood group cards, AHG cards, anti-sera, and pooled screening cells)
    3) checking machines and devices maintenance and performance according to SOPs and maintenance
    sheet including , fully or semi-automated CAT devices (incubators - centrifuges) , sample tube centrifuge,
    pipettes and refrigerators.
    4) QC of the used kits and reagents
    A) Blood grouping cards using A neg, B neg , AB neg , and O positive suspensions to verify that
    cards can detect antigens properly.
    B) AHG cards using negative and positive control serum against o positive cell suspension.
    C) Pooled screening cells using positive and negative control serum
    D) Anti-D anti-sera using (A neg, B neg , AB neg , and O positive suspensions) +Anti-D in AHG card

    2nd Q :What is the flow chart of blood group sample in serology Lab?

    MRL
    Station 1) : using the provided Elisa kit for ( Hcv Ab , HBsAg , HIV AG/Ab, or syphilis) construt your
    working sheet & monitoring sheet for the sample given:
    ⺁ ⺁ 폸኿⺁ ⺁ Ϯ Ϡ τ⺁ Β Θτ ΒΘ ⺁ Β Ϯ
    Name of the assay
    Reagent preparation ⺁ Β τ⺁ ኿Ϯ τ⺁ Ϯτ⺁ Ϯ ⰞΒ Ⱎ
    Procedure ኿ΘΘ ⺁ Ro ‫ ف‬Β Β኿Ϯ ⺁ ϮΘ ኿ ⸱Β
    Incubation time and temperature ⺁ ⺁ ϮΘ Ϯτ⺁ ⺁ R ⺁ ⺁ ⰞΒτ⺁
    Stop , and reading wave length ⺁ τ⺁ Ϯτ⺁ Ϯ Ϡ τ⺁ ⸱

    Work sheet : ⺁Θ Β኿ ⺁ R Β ⺁ ⺁ Β⸱ τ⺁ ⸱ τ⺁ ϠR Βτ
    Monitoring sheet : ϮΒ ⺁ ⺁ R ⰞΒτ⺁ R ΒliΒ τ⺁ ⺁ ⺁ Β ⺁ ⺁ϮϠ Βτ ⺁
    ⺁R m ⺁ Β ኿ 10:00 Β 9:00 Β Θ툘Β ⺁ Ⱎ R Θ Β Β lΘ RϮΘ Ϯ ⰞΒ ⰞΒΒ ⺁
    l Θ Ϡτ⺁ ⸱ ‫ف‬l ኿ �
    Ϡ i τ⺁ ኿ ⸱䁕 Β ⺁ Ⱎ኿ R R ⺁ τ τ⺁ Β ኿ ⺁lR ⸱኿⺁ iΒτ⺁ ⺁ ⰞΒτ⺁ ⺁ ⸱τ Θ l ኿
    Ϯτ⺁ Ϯτ⺁ Ϯ ⰞΒ Ⱎ ⺁ Θ툘Β
    *Wash 20X means 1: 19 , wash : distilled water, if we need 200ml ===> 10 wash : 190 DW
    If we need 400ml ===> 20 wash : 380 DW

    * conjugate and substrate if needed preparation , spot method of preparation in pamphlet.


    ⸱ τ⺁ l Θ R ⺁ ⺁ Β⸱ ΒR Ϯ τ⺁ ⸱τ⺁ l Θ Β⺁ Ϯ Ϯ ⸱ ϮRϮΒ Ϯτ
    Station 2): you are provided by print-out of an ELISA for test , validate the test and interpret results.
    You will be given kit pamphlet and test kit
    Use test pamphlet to have VALIDATION CRITERIA , and write it in details in your answer sheet

    In the above part of pamphlet , I spotted validation criteria as follow:


    * blank valid if between ( -0.020 , 0.050)
    * NC should be < 0.120
    * PC should be > 0.800
    If validation criteria is met , so the RUN IS VALID ,
    Proceed to calculations of Mean NC, the calculate the cut-off using the constant provided
    Cut-off = Mean NC + 0.6 then calculate gray zone = cut-off X 0.8 because this HCV kit
    Gray zone for HIV, HBsAg ,syphilis = cut-off X 0.9

    ** QC sample is placed following controls or as the last sample of the plate


    QC ratio should be calculated (OD/cut-off) and then compared to reference range provided.

    Station2)
    You are given results for QC samples for Biorad HBsAg:
    Day 1 2 3 4 5 6 7 8 9 10
    Ratio 4.9 5.2 4.6 5.7 6.1 2.8 3.4 6.1 5.2 7.1
    Provided that SD = 0.7
    Draw a plot the graph.

    Answer: Calculate Mean and SD (standard deviation) of the results


    Mean = sum of all results divided by their count number= 51.1/10 =5.1
    If one SD= 0.7 so 2SD = 1.4, and 3SD= 2.1
    and upper control level = mean+ 3SD = 5.1+2.1= 7.2 & LCL= mean - 3SD=5.1-2.1=3.0
    ⸱τ⺁ lⰞ ኿ τ⺁ ኿τ⺁ Β
    ⺁ R኿ Β Ϯ τ Θ ϠΒ 䁕 Β Θτ⺁ Ϯ m 7.2 3.0 ⺁ Θ R Β⸱τ⺁ Β l ⺁ Ϯτ
    Scenarios to say that I have invalid QC results
    1) Outside + or - 3SD 2) 5 or 7 points on one 3) Trend 4) Cyclic
    side of the Mean ኿ ⺁ τ ϮΒ τ⺁ τ⺁Ϯ ኿ τ
    Causes of invalid QC results
    Sample related causes Procedure related causes
    1) Improperly stored/ transported 1) expired kit
    2) Contaminated 2) Non- maintained / un-calibrated devices
    3) Preservation temp. Is not maintained 3) Missed steps in procedure
    4) Deteriorated (repeated thaw/ freeze cycles) 4) Non trained operator
    5) Expired sample 5) Carry over by washer
    6) Failure to interpret with proper kit

    You are given results for QC samples for Biorad HBsAg:


    Day 1 2 3 4 5 6 7 8 9 10
    Ratio 4.9 5.2 4.6 5.7 6.2 2.8 3.4 6.1 5.2 7.1
    Provided that SD = 0.7
    Calculate mean , mode , median
    Mean = sum of values/number of values= 51.1/10= 5.11
    Mode = most frequently repeated value = 5.2
    Median = middle value between ascending or descending arrangement (if odd number of values)
    = mean of 2 middle values betweenascending or descending arrangement (when even number)
    7.1 , 6.2 ,6.1 ,5.7 ,5.2 ,5.2 ,4.9 ,4.6 ,3.4, 2.3
    5.2 2 5.2 5.2 Ϡ ϮΒΒ ⸱m τ⺁ Β iτ⺁ τ⺁ m ⸱ R ኿ ኿l⸱
    So median = 5.2

    Infection control
    Q1:what are the moments in your practise that require hand hygiene ?

    Q2: what are missed parts of hand during hand wash?


    Q3: face mask is one of PPEs that require special care during putting on and taking off
    Mention do and don’t with face mask

    DO DON’T

    Wear a mask that covers your nose and mouth Hold onto the cover when you apply your mask
    * Wash your hands before putting a mask on Adjust or touch the mask once it’s on properly
    *Put the mask on using the straps instead of Slide it down under your chin
    touching the cloth Wear it if it’s soiled, wet, ripped, or damaged in
    *Remove the mask by the straps any way
    * Wash your hands after you take it off Share your face mask with someone else
    Store it in a clean, dry container
    Wash your mask daily in hot water

    Q3: waste disposal and management steps


    1) Segregation At point of origin in special colored bag
    2) collection By janitors wearing duty gloves and foot wear
    3) storage Dedicated place -impermeable- good drainage - cleanable surface
    4) transportation Dedicated vehicle out of facility
    5) Treatment Either by incineration or chopping and sterilization
    6) Final disposal Burring in sanitary landfill (solids) or pouring in special sinks (liquids)

    Q4: during your work in components lab department , blood bag ruptured and caused blood spill
    How janitors should respond to large blood spill and small blood spill
    1) Wear full protective PPE Small spill
    2) Remove blood with towel , cotton , or tissue 1) Wear protective gloves
    paper, the discard it to red waste bag. 2) Sweep the surface several times with
    3) Pour disinfectant (chlorine 5000 ppm on site of disinfectant and tissue paper
    spill and leave for 10 minutes. 3) Finally clean the surface.
    4) Dry disinfectant with tissue paper
    5) Finally clean the surface

    Q6: how to prevent and minimize the risk of blood born infection in your lab?
    A6:
    1) Promote HBV vaccination among health care workers.
    2) Apply the standard precaution of infection control.
    3) Prevent per-cutenous injuries by implementing safe injection policies and procedures.
    4) Avoid needle recapping
    5) Apply the work practise ethics.
    6) Using the engineering controls.

    Q7: one of your team is exposed to blood , how to manage ?


    A7:
    1) Wound care CLEAN BY SOAP & WATER NO milking , no antiseptic no , disinfectant at wound
    2) Fill an exposure report.
    3) Determine risk associated with the exposure (type of fluid- type of exposure.)
    4) Evaluate exposure source.
    5) Give PPEs to personnel involved in risk of exposure to infection transmission.
    6) Provide counselling for the exposed person.
    7) Perform followup testing.

    Q8: what are levels of risk of blood borne infections?


    HIV ------> 0.2 - 0.4 %
    HCV ------> 3 - 10 %
    HBV ------> 27 - 37 %

    Q9: COVID 19
    폸⸱τ⺁ Β ⺁ R ⰞR τ⺁

    RCRL
    Station 1) Ab screening and id identification
    Β኿Ϯ Ϯ ⺁ ϮΒ Β ኿ ⺁ � 11 Β 1 Β R Β R ml Θ � R τ ኿ R R Ϡ Βm
    τ ⺁ ΘΘ ab screening
    0 ⺁4 Β⺁ ⸱R Θ Θ Βτ⺁ Ⱎ ⺁ τ⺁ Ϯ Βm
    ⺁ τ⺁ R Β⸱τ⺁ Β⺁ Ϡ኿Βτ⺁ ‫ف‬l ኿ Rl Θ ⺁ R Β኿ ⺁ ⺁ R Β⸱τ⺁ ኿⺁
    Β⸱τ⺁ l኿ τ⺁ Ϯ኿኿ Rl Θ

    Follow up questions will be like those:


    1) What is the most probable antibody the patient has?
    2) What antibodies can`t be excluded? What further steps should be taken to exclude them?
    3) If patient needs blood , what unit phenotype should be provided?
    4) An embedded question to test RH phenotype nomenclature
    Station 2: ABO discrepancy case = the same gel card and you will observe grads of reaction
    Questions will be like this:
    1- What is most probable cause of this discrepancy ?
    2- What are the causes of Abo discrepancies?
    3- What is the most common cause of group discrepancies:
    4- How to resolve a case of ABO discrepancy?
    Q1: how to validate anti-sera?
    A1: by checking its
    specificity Sensitivity stability Avidity ( speed of reaction) Potency (by titration)

    Q2: How to validate a blood group card?


    A2:
    1) By checking its reactivity in various blood groups using
    (Aneg , B neg , AB neg and o psitive cell suspensions)
    2) Checking its reactivity in subgroup reactions e.g A2
    3) Checking its reactivity in case of weak D

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