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    Leishcheck: Size: 137 X 218 MM

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    Matibar Rahman
    Leishcheck is a rapid test device for detecting antibodies to Visceral Leishmaniasis (VL) in human serum or plasma. VL is a parasitic disease transmitted through sandfly bites that affects over 500,000 people annually. The test uses a membrane strip coated with VL antigens and gold-conjugated proteins to detect antibodies in a sample, showing positive or negative results within 10 minutes. In a clinical trial comparing it to another product, Leishcheck correctly identified 199 out of 200 negative samples and all 50 positive samples.

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    Leishcheck: Size: 137 X 218 MM

    Uploaded by

    Matibar Rahman
    115 views4 pages
    Leishcheck is a rapid test device for detecting antibodies to Visceral Leishmaniasis (VL) in human serum or plasma. VL is a parasitic disease transmitted through sandfly bites that affects over 500,000 people annually. The test uses a membrane strip coated with VL antigens and gold-conjugated proteins to detect antibodies in a sample, showing positive or negative results within 10 minutes. In a clinical trial comparing it to another product, Leishcheck correctly identified 199 out of 200 negative samples and all 50 positive samples.

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    Leishmania

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    Leishcheck is a rapid test device for detecting antibodies to Visceral Leishmaniasis (VL) in human serum or plasma. VL is a parasitic disease transmitted through sandfly bites that affects over 500,000 people annually. The test uses a membrane strip coated with VL antigens and gold-conjugated proteins to detect antibodies in a sample, showing positive or negative results within 10 minutes. In a clinical trial comparing it to another product, Leishcheck correctly identified 199 out of 200 negative samples and all 50 positive samples.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    115 views4 pages

    Leishcheck: Size: 137 X 218 MM

    Uploaded by

    Matibar Rahman
    Leishcheck is a rapid test device for detecting antibodies to Visceral Leishmaniasis (VL) in human serum or plasma. VL is a parasitic disease transmitted through sandfly bites that affects over 500,000 people annually. The test uses a membrane strip coated with VL antigens and gold-conjugated proteins to detect antibodies in a sample, showing positive or negative results within 10 minutes. In a clinical trial comparing it to another product, Leishcheck correctly identified 199 out of 200 negative samples and all 50 positive samples.

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    © All Rights Reserved
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    Size : 137 x 218 mm

    TM

    Leishcheck
    Rapid test for detection of Visceral Leishmaniasis antibody in human serum/plasma
    DEVICE

    INTENDED USE
    LeishcheckTM is a rapid, self-performing two site qualitative immunoassay for the detection of antibodies to L. donovani in
    human serum/ plasma. The test is intended for the presumptive diagnosis of Visceral Leishmaniasis (VL). For professional in
    vitro diagnostic use only.

    SUMMARY
    Visceral Leishmaniasis (VL), also known as Kalazar, is a vector-borne parasitic disease which is nearly always fatal if left
    untreated. VL is one of the world's most neglected diseases, largely affecting the poorest people, mainly in developing
    countries. VL is endemic in 60 countries and some 500,000 new cases occur annually. The disease is transmitted through the
    bite of an infected phlebotomine sandfly. The host reservoir varies in different parts of the world, reflecting a difference in
    parasite, in Europe and South America the causative organism agent is Leishmania infantum, which has the domestic dog as
    its main reservoir, in the Indian subcontinent (ISC) (Bangladesh, India, Nepal) and in East Africa, the causative organism is L.
    donovani strains.
    Earlier, accurate VL diagnosis necessitated parasitological confirmation by microscopy or culture of the blood, bone-marrow,
    lymph nodes or spleen. Microscopic detection of parasites in clinical material from the spleen is still considered the reference
    standard; however, splenic aspirates are associated with risks of serious bleeding and should only be carried out in settings
    with access to blood transfusion and surgical services. The invasiveness and potentially fatal complications associated with
    splenic aspiration has motivated the development of non-invasive serological tests lateral flow immuno-chromatographic tests
    (ICT), commonly referred to as rapid diagnostic tests (RDT). RDT is seen as a potential breakthrough allowing user and patient
    friendly, rapid diagnosis in peripheral health care settings.
    LeishcheckTM qualitatively detects the presence of IgG antibodies to Visceral Leishmaniasis in human serum or plasma.

    PRINCIPLE
    LeishcheckTM utilizes the principle of agglutination of antibodies/ antisera with respective antigen in immuno-chromatography
    format along with use of nano gold particles as agglutination revealing agent. The test membrane is stripped with recombinant
    K39 antigen and a reagent control. The test specimen is added followed by sample running buffer and allowed to move along
    the membrane. The IgG present in the specimen binds to the Protein-A coated on the colloidal gold forming an IgG-Protein-A
    gold complex. This complex moves along the membrane where it is immobilized by the recombinant K39 antigen (VL specific)
    coated on the membrane forming a pink/purple colored band. The absence of this colored band in the test region indicates a
    negative test result.
    The unreacted conjugate and unbound complex if any, moves further on the membrane and are subsequently immobilized by
    the reagent control coated on the membrane at the control region, forming a pink/purple band. This control band acts as a
    procedural control and serves to validate the test performance.

    REAGENTS AND MATERIALS SUPPLIED


    A. Each LeishcheckTM kit contains individual pouches each containing a,
    1. DEVICE Membrane assembly predispensed with Protein A-colloidal gold conjugate, recombinant K39 antigen (VL
    specific) and reagent control coated at the respective regions.
    2. Desiccant pouch.
    3. PIPETTE Disposable sample applicator.
    B. BUF Sample running buffer in a dropper bottle.
    C. Package insert.

    REF 503100010 503100005


    10T 5T

    OPTIONAL MATERIAL REQUIRED


    Calibrated micropipette capable of delivering 5µl sample accurately.

    STORAGE AND STABILITY


    The sealed pouches in the test kit & the kit components may be stored between 4°C to 30°C till the duration of the shelf life as
    indicated on the pouch/ carton. DO NOT FREEZE. After first opening of the sample running buffer bottle, it can be stored
    between 4°C to 30°C for the remaining duration of its shelf life.

    NOTES
    1. Read the instructions carefully before performing the test.
    Size : 137 x 218 mm

    2. For in vitro diagnostic use only. NOT FOR MEDICINAL USE. For professional use only.
    3. Do not use the kit beyond expiry date and do not re-use the test device.
    4. Do not intermix the reagents from different lots.
    5. Handle all specimens as potentially infectious. Follow standard biosafety guidelines for handling and disposal of
    potentially infective material.
    6. Contact with the contents of desiccant pouch containing, among other substances, cobalt chloride (CAS# 7646-79-9)
    should be kept to a minimum. Inhalation / swallowing may cause harm.
    7. Sample running buffer contains Sodium Azide (0.1%), avoid skin contact with this reagent. Azide may react with lead and
    copper in the plumbing and form highly explosive metal oxides. Flush with large volumes of water to prevent azide build-
    up in the plumbing.

    SPECIMEN COLLECTION AND PREPARATION


    1. LeishcheckTM kit uses human serum/plasma as specimen.
    2. No special preparation of the patient is necessary prior to specimen collection by approved techniques.
    3. Though fresh specimen is preferable, in case of delay in testing, it may be stored at 20C to 80C for maximum upto 24 hours
    before testing.
    4. Refrigerated specimens must be brought to room temperature prior to testing.
    5. Do not use viscous/ turbid, lipaemic, hemolysed, clotted and contaminated serum/plasma specimens.
    6. Specimens containing precipitates or particulate matter must be centrifuged and the clear supernatant only used for
    testing.

    TESTING PROCEDURE AND INTERPRETATION OF RESULTS


    1. Bring the LeishcheckTM kit components and specimen to room temperature before testing.
    2. Open the pouch and retrieve the test device, sample applicator and desiccant pouch. Check the color of the desiccant. It
    should be blue, if it has turned colorless or pink discard the device and use another device. Once opened, the device
    must be used immediately.
    3. Label the test device with patient's identity.
    4. Tighten the cap of the sample running buffer bottle provided with the kit in the clockwise direction to pierce the buffer bottle
    nozzle.
    5. Dip the sample applicator into the serum/plasma sample. Ensuring that an applicator full of serum/plasma sample is
    retrieved, blot the collected sample in the sample port ‘S’ (This delivers approximately 5µl of the serum/plasma sample).
    OR
    Alternatively, using a calibrated micropipette add 5µl serum/plasma sample at the sample port ‘S’ of the test device.
    NOTE: Ensure that the serum/plasma sample from the sample applicator has been completely taken up by the sample port
    ‘S’.
    6. Immediately dispense two drops of sample running buffer in the same port. Allow the first drop to soak in, then add the
    second drop.
    7. Read results at the end of 10 minutes as follows:

    T Negative Result
    Only one pink/purple band appears at the control region 'C'.
    T Positive Result
    In addition to the control band, a pink/purple colored band also appears at the test region 'T'.

    T Invalid Result
    The test should be considered invalid if no bands appear on the device. The test should also be
    T considered invalid if only test band appears and no control band appear. Repeat the test with a new
    device ensuring that the test procedure has been followed accurately.

    PERFORMANCE CHARACTERISTICS
    In an in-house study LeishcheckTM was evaluated with 50 positive serum samples and 200 negative serum/plasma samples
    tested with a commercially available similar product in parallel. The positive patient; from whom said serum samples were
    collected was also confirmed with splenic puncture microscopy LD body detection. The results obtained were as follows:

    Sample Total No. of Samples Tested Competitor Brand LeishcheckTM


    Negative 200 200 199
    Positive 50 50 50
    Total 250 250 249
    Size : 137 x 218 mm

    LIMITATIONS OF THE TEST


    1. As with all diagnostic tests, the result must be correlated with clinical findings.
    2. The test detects the presence of antibodies to L. donovani in the specimen and hence should not be used as a sole criterion
    for the diagnosis of Visceral Leishmaniasis infection. A false positive result may occur. It is advisable to confirm such cases
    with a confirmatory testing (such as culture).
    3. A negative result at any time does not preclude the possibility of exposure to or infection with L. donovani. If the test result is
    negative and suspicion still exists, additional follow-up testing using other clinical methods is recommended.
    4. LeishcheckTM should be used as a screening test in clinical suspected cases only and its results should be confirmed by
    confirmatory test methods (such as culture) before taking clinical decisions.
    5. Most positive results develop within 10 minutes. However certain specimens may take a longer time to flow therefore,
    negative should be confirmed only at 15 minutes. Do not interpret the test results beyond 30 minutes.
    6. Interference due to presence of heterophile antibodies in patient's sample can lead to erroneous analyte detection in
    immunoassay, has been reported in various studies. LeishcheckTM uses HETEROPHILIC BLOCKING REAGENT (HBR)
    to inhibit majority of these interferences.
    7. The test may be false positive with specimens from patients having malaria and Chagas disease.

    WARRANTY
    This product is designed to perform as described on the label and package insert. The manufacturer disclaims any implied
    warranty of use and sale for any other purpose.

    BIBLIOGRAPHY
    1. WHO. 1990. Control of the Leishmaniases, World Health Organization, Technical Report Series No. 793.
    2. Badaro, R., S.G. Reed, and E.M. Carvalho. 1996, The Journal of Infectious Diseases 173; 758-761.
    3. Burns, J.M., W.G. Shreffler, D.R. Benson, et al. 1993. Proc. Natl. Acad. Sci. (90) 775-779.
    4. Data on file: Zephyr Biomedicals.
    Size : 137 x 218 mm

    SYMBOL KEYS
    Consult
    Temperature
    Limitation
    Instructions
    for use
    Date of
    Manufacture 2 Do not reuse

    In vitro Diagnostic Disposable


    Manufacturer IVD Medical Device
    This side up PIPETTE sample applicator

    Catalogue
    Use by REF Number DEVICE Device
    EC REP
    Contains sufficient Batch Number / Sample Running Authorised Representative
    for <n> tests LOT Lot Number BUF Buffer in the European Community

    Manufactured by:
    Zephyr Biomedicals
    A Division of Tulip Diagnostics (P) Ltd.
    M 46-47, Phase lIl B, Verna Industrial Estate, Verna, Goa - 403 722, INDIA.
    Regd. Office: Gitanjali, Tulip Block, Dr. Antonio Do Rego Bagh, Alto Santacruz,
    0817/VER-01

    Bambolim Complex P.O., Goa - 403 202, INDIA.

    EC REP
    CMC Medical Devices & Drugs S.L., Spain.

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