Internal Information Sheet
Contents
1. gloves and avoid mouth pipetting during the test 2 Do not eat smoke apply cosmetics or touch contact lenses in the testing area where samples and reagents are handled 3 The sample dilution buffer and the latex suspension contain sodium azide at a concentration of 0 1 or lower as a preservative If the reagent accidently comes into contact with the eyes or skin immediately and thoroughly rinse the area with water and seek medical treatment if necessary 2 Precautions for Use 1 This product should be stored as directed Avoid freezing Do not use the product if it has frozen stored under conditions other than those specified or has expired 2 Do not mix sample dilution buffer and latex suspension of different lots 3 Prepare a calibration curve for every testing Do not change the bottles and lots of sample dilution buffer or latex suspension during testing 4 Use the thermostat of analyzer to keep reaction temperature constant 5 Check the reagent bottle and its label before testing Do not use the reagent if the label has been peeled off or if the label is smudged and illegible 3 Precautions for Disposal 1 To avoid infection from HIV HBV or HCV waste fluid and instruments should be disinfected with sodium hypochlorite effective chlorine concentration 1000 ppm immerse for over hour or with glutaraldehyde 2 for over hour or sterilized with an autoclave at 121 C for 20 minutes 2 The2. reagent contains sodium azide Sodium azide may react with lead or steel pipes and produce highly explosive metallic azide When disposing reagents flush out with copious amounts of water 3 The reagents should be disposed in accordance with water pollution control regulations or related regulations Storage and Shelf Life 1 Storage temperature 2 8 C avoid freezing 2 Shelf life 1 year from the date of manufacture The expiration date is printed on the outside of the package Package Contents 1 Mediace TPLA A Description Configuration Sample Dilution Buffer 18 mL x 4 Latex Suspension 10 mL x 1 2 Mediace TPLA M Description Configuration Sample Dilution Buffer 49 mL x 2 Latex Suspension 14mL x1 References 1 Kazuhisa Osato et al Clinical Evaluation of Reagents for Latex Agglutination Test for Anticardiolipin Antibody and Anti TP Antibody Journal of Japanese Society for Sexually Transmitted Diseases 13 124 130 2002 2 SEKISUI MEDICAL CO LTD In house data Marketing Authorization Holder SEKISUI MEDICAL CO LTD 13 5 Nihonbashi 3 chome Chuo ku Tokyo Japan international sekisui com Mediace is a trademark owned by SEKISUI MEDICAL CO LTD JAPAN and is registered in Japan and or other countries Revised Apr 2008 1st edition
3. This product marketed by SEKISUI MEDICAL CO LTD Tokyo Japan is manufactured subject to our supervision as stipulated in the Pharmaceutical Affairs Law of Japan and is allowed to be sold in Japan For details please contact us or your local distributors Treponema Antibody Kit Mediace TPLA General Precautions 1 This product is for in vitro diagnostic use only and must not be used for any other purposes 2 Clinicians should make a comprehensive clinical decision based on assay results in conjunction with clinical symptoms and other examination results 3 This product should be used only as directed Reliability of values cannot be guaranteed if this product is used for purposes or tested by methods other than those stated 4 Read the user s manual of your automated analyzer prior to using this kit Parameters for different automated analyzers are available upon request Analyzers should be cleaned before use to ensure accurate calibration Descriptions Kit Components Component Ingredients Sample Phosphate buffer containing bovine dilution serum albumin buffer Latex Treponema pallidum antibody coated suspension latex Intended Use For the measurement of anti treponema antibody in serum Assay Principle The reaction between the treponema pallidum antibody coated latex and anti treponema antibody in sample occurs agglutination under given conditions The anti treponema antibody titer is ca
4. hi 7170 automated analyzer 1 Mix 175 uL of sample dilution buffer and 16 uL of sample and incubate the mixture at 37 C for about 5 minutes 2 Add 25 uL of latex suspension and incubate mixture at 37 C 3 Measure turbidity changes from 50 seconds to 4 minutes at 700 nm 4 Prepare a calibration curve based on the turbidity changes in standard serum by following the same procedure as above and calculate anti treponema antibody titer based on the turbidity changes Assessment of Results 1 Assessment of Results Positive gt 10 T U T U is the abbreviation of TITER UNITS for anti treponema antibody 1 T U equals 2 mIU with WHO reference material 2 When results come out positive run subsequent tests and make a decision taking in consideration other examination results and clinical symptoms 3 Clinicians should make a comprehensive clinical decision based on assay results in conjunction with clinical symptoms and other examination results Do not make a diagnosis based on results obtained from this kit alone 4 Serum collected from patients in the early stage of anti treponema antibody production or with decreased antibody producing ability due to compromised immune function may test negative 5 A non specific immune reaction may occur in serum samples from patients with autoimmune diseases 6 Serum samples from patients receiving blood products containing immunoglobulin may test positive Evaluate test results carefull
5. lculated on the difference in pre and post reaction turbidities resulting from agglutination Procedural Precautions 1 Sample Collection 1 Serum can be used 2 Collected sample should be used while they are fresh 3 Samples should be handled carefully to prevent infection 2 Interfering Substances Assay results will not be affected by bilirubin up to 20 mg dL hemoglobin up to 1500 mg dL and rheumatoid factor up to 1800 IU mL Assay Procedures 1 Reagent Preparation 1 Sample Dilution Buffer Mix well by gently inverting the bottle to avoid bubble formation prior to use 2 Latex Suspension Mix well by gently inverting the bottle to avoid bubble formation prior to use 2 Assay Method Perform the assay according to the operating instructions for each automated analyzer Refer to the Methodology Sheet for detailed assay methods Contact SEKISUI MEDICAL CO LTD for information on parameters to be used with other types of analyzers 1 Preparation of calibration curve Mix standard serum sample dilution buffer and latex suspension to start the reaction Prepare a calibration curve based on a difference in turbidities at predetermined times Standard serum is sold separately 2 Sample Analysis Measure turbidity changes by following the same procedure as described in Preparation of calibration curve and calculate anti treponema antibody titer based on the calibration curve 3 Parameters for the Hitac
6. y Revised Apr 2008 1st edition This product marketed by SEKISUI MEDICAL CO LTD Tokyo Japan is manufactured subject to our supervision as stipulated in the Pharmaceutical Affairs Law of Japan and is allowed to be sold in Japan For details please contact us or your local distributors 7 Keep in mind that the prozone phenomenon which is associated with immune response may affect results Performance 1 Performance The performance when used in accordance with standard testing method is described below 1 Sensitivity 1 Turbidity change in a normal human serum syphilis negative lt 0 01 2 Turbidity change in a positive control serum of around 450 T U 0 10 0 70 2 Accuracy 1 Positive control serum at given concentration is always 10 T U or higher Negative control serum at given concentration is always 10 T U or less 3 Within run Reproducibility Coefficient of variation lt 15 Assay of 10 replicates using a positive control serum of a known concentration 4 Measurement Range on the Hitachi7170 automated analyzer 5 250 T U 2 For samples exceeding 250 T U dilute with antibody negative serum prior to testing 2 Correlation N 171 r 0 828 y 1 06x 10 5 Reference method TPHA other manufacturer 1 2 Precautions and Warnings 1 Handling Precautions 1 All samples used in the test should be handled as if potentially infectious for HIV HBV and HCV To prevent infection use disposable
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