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Tri Screen Canine Lymphoma Assay Pack Insert
 

Tri Screen Canine Lymphoma Assay Pack Insert

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Tri Screen Canine Lymphoma Assay Pack Insert

Tri Screen Canine Lymphoma Assay Pack Insert

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    Tri Screen Canine Lymphoma Assay Pack Insert Tri Screen Canine Lymphoma Assay Pack Insert Document Transcript

    • Canine Lymphoma Diagnostic Assay KitCat. No: TSC-501BackgroundLymphoma is one of the most common cancers to affect dogs, with certain breeds exhibiting anextremely high prevalence. Incidence rates (like most neoplasms) increase dramatically with age,and dogs from middle age onwards are most affected. The disease does however respond well totreatment with chemotherapy, particularly if diagnosed early.The disease usually presents with swollen lymph nodes which can ofte be confused with ofteninfection during initial differential diagnosis. Delays in diagnosis can therefore be common if thepractitioner treats with antibiotics and waits for the lymphadenopathy to subside. This approachresults in crucial delays since lymphoma develops very rapidly. Currently diagnosis of lymphomarequires invasive procedures such as fine needle aspiration or excision of the affected lymphnode. Since the affected dog appears otherwise well, it is understandable that the vet wouldchoose to postpone invasive work until more information becomes available. tponeThe Tri-Screen Canine Lymphoma Assay helps overcome these difficulties by providing a sameday turnaround test which is able to differentiate between lymphadenopathy of non non-malignantorigin and lymphoma. Since the test requires only a small amount of blood, the test helps the vetmake rapid decisions about diagnostic procedures and treatments when confronted with a dogexhibiting swollen lymph nodes.Often lymphoma also presents in nonnon-peripheral lymph nodes. Under these circumstances, other alsigns such as general malaise, hypercalcaemia or PU/PD indicate the disease. Furthermore, it isextremely difficult to biopsy the affected node in non peripheral lymphoma. In these cases, the non-peripheralTri-Screen Canine Lymphoma Assay provides the vet with a new, valuable tool to inform the nedecision on progressing to additional costly or invasive procedures.The Tri-Screen Canine Lymphoma Diagnostic Kit represents a unique approach to the diagnosis creenof Canine Lymphoma. The kit is a three part diagnostic system which utilizes assays for two acute three-partphase proteins, Haptoglobin and CRP and then produces a diagnosis through t application of a thepatented algorithm to the Haptoglobin and CRP results which is accessed via the Tri ssed Tri-Screen.netwebsite.Full instructions follow on the methodologies for performing the assays and a accessing the Tri-screen.net website.Please note: each Tri-Screen Canine Lymphoma Diagnostic Kit contains a unique Screenidentification code number on the inside of the kit box lid. This number is required everytime you wish to access the diagnostic algorithm on the website. This ID number must becarefully recorded to allow access to your stored results and history history.To obtain a result from the Tri Tri-Screen Canine Lymphoma Diagnostic Kit, all three components ofthe assay must be performed.The first time the kit is used, users must register as a u user at www.tri-screen.net/register/ screen.net/register/The user can register on the website by completing a short registration procedure and set up their he mpletingown individual user name and password. This is designed to ensure that results and informationfrom each individual user are kept in a safe and secure manner. There is no need to follow this ach
    • procedure with every kit purchased, registration is a one-time procedure and the user name andpassword remain the same once set up.Further details of how to use the website to obtain results follow in section 3 of this manual.Methodologies for the individual components of the kit follow1. The Haptoglobin Assay Methodology2. The Canine CRP Assay Methodology3. Accessing the Tri-Screen.net website and obtaining a result.The Haptoglobin assay has shown equivalence between serum and plasma samples. CRP hasnot been fully investigated in this respect. It is therefore recommended that serum samples areused for both tests in this assay.Section 1: The Haptoglobin AssayIntended UseThis is a colorimetric assay designed to quantitatively measure the concentration of the acutephase protein Haptoglobin in serum and plasma.ApplicationThe activation of the body’s immune system-mediated defence mechanisms is termed the acutephase response. Haptoglobin is one of a series of acute phase proteins that is found in the bloodof a range of animal species. Under normal conditions, it is either absent from the blood orpresent at very low levels. Normal ranges can vary between species and in Canines the normalrange is 0.3 – 3.5mg/ml. However, Haptoglobin has been identified as a marker for lymphoma indogs when utilised as part of this kit. The individual result for Haptoglobin is not indicative oflymphoma itself and a diagnosis of lymphoma may only be obtained through the completion of allthree parts of the process.Test PrincipleFree haemoglobin exhibits peroxidase activity, which is inhibited at a low pH. Haptoglobin presentin the specimen combines with haemoglobin and at a low pH preserves the peroxidase activity ofthe bound haemoglobin. Preservation of the peroxidase activity of haemoglobin is directlyproportional to the amount of Haptoglobin present in the specimen. This assay can be performedin manual or automated formats.Reagents & Materials Provided1. Reagent 1 (R1) 1 x 14ml stabilised Haemoglobin. (Ready to use)2. Reagent 2 (R2) 1 x 20ml Chromogen reagent (Ready to use)3. Calibrator 1 x 0.5ml Haptoglobin Calibrator (2.5mg/ml).4. Sample/Calibrator Diluent 1 x 12ml Phosphate Buffered Saline Diluent (Ready to use).Additional Materials Required1. Serum or plasma collection equipment.2. Automated analyser (A600nm) or Microplate reader (A630nm).3. Accurate micropipettes or multichannel pipettes and disposable tips to deliver 0-10µl and 50- 200µl4. Test tubes.5. Timer.6. Graph paper: Linear (Cartesian)7. 96 well microtitre plate or strips or alternative reaction chamber such as photometer cup etc.8. Vortex9. Centrifuge 2
    • Reagent Preparation & Use Haemoglobin (R1) This reagent is provided in a ready to use format (Reagent 1). Chromogen (R2) This reagent is provided in a ready to use format (Reagent 2). Calibrator/sample diluent This reagent is provided in a ready to use format. Calibrator (Microplate Method) Calibration is run in the form of a standard curve for each assay. The standard curve dilution series is prepared manually or automatically on an automated analyser. For the manual method label five tubes with numbers C1-C5, corresponding to Haptoglobin standards 2.5, 1.25, 0.625, 0.312 and 0 mg/ml respectively. Calibrators for this test format are prepared by following the steps provided in the table: Tube No: Volume Volume Diluent Tube Calibrator Concentration C1 50µl of stock - 2.5 mg/ml C2 50µl of stock 50µl 1.25mg/ml C3 50µl C2 50µl 0.625mg/ml C4 50µl C3 50µl 0.312mg/ml C5 - 50µl 0mg/ml Calibrator (Automated Methods)• For automated procedures single point calibration may be used by dilution of the 2.5mg/ml standard 1:1 to give a 1.25mg/ml calibrator.• Alternatively, use only 0, 0.625 and 2.5mg/ml calibrator. (Haptoglobin standard of 0.625mg/ml can be prepared by adding 50ul of 2.5mg/ml standard to 150ul of calibrator diluent).• Multi-point calibration curves can also be used.• Note: Account should be taken of the fill volume of calibrator material which may be required depending on the automated system in use. Assay the calibrators in the context of an internal calibration programme. Sample Preparation• This method has demonstrated serum/plasma equivalence using lithium-heparin blood collection tubes for plasma.• Blood samples may be kept for up to 24 hours before separation of serum.• It is recommended that serum is removed from the clot or cells as soon as possible after o collection. Serum may be stored at 2-8 C for up to 24 hours before screening or alternatively o stored long-term frozen at -20 C for up to one year.• For most species, samples are tested neat and only require dilution if the Haptoglobin level is above the highest calibrator concentration. However for canine, use of a starting sample dilution of 1:5 is recommended by adding 10µl of sample to 40µl of calibrator/sample diluent.• It is important that all samples are brought to room temperature and vortexed vigorously to ensure accurate determination of the Haptoglobin concentration.• Do not use grossly haemolysed or lipaemic samples. 3
    • Test Procedure A. Manual method (microplate or spectrophotometric) Note: Addition of Reagent 1 and Reagent 2 should be made with a multi-channel or repeating pipette.1. Transfer 7.5ul of each prepared calibrator (0-2.5mg/ml) along with test specimens, in duplicate, to the blank microplate.2. Add 100ul of Reagent 1 to each microwell. Tap the microplate gently to ensure mixing of calibrators/specimens and haemoglobin. o3. Add 140ul Reagent 2 to each microwell. Incubate for 5 minutes at room temperature (20-25 C).4. Read immediately at 600-630nm. B. Automated Method (2 reagent procedure).1. Dispense the required amount of Reagent 1 and Reagent 2 into the appropriate storage vessels on the instrument.2. Aliquot the required volume of sample, controls and calibrator into the appropriate sample cups.3. Read at 600-630nm while the calibration curve is developing, preferably at the peak of the calibration curve. Caution: Do not let the calibration curve ‘over-develop’ and undergo a wavelength shift (change in colour from blue to light brown) Test Temperature o o o The test can be performed at 25 C, 30 C or 37 C on analyzers or at room temperature on the manual format. Interpretation of Results • Calculate the mean absorbance for each sample, control or standard. • Generate a calibration curve by plotting absorbance (600-630nm) versus Haptoglobin concentration (mg/ml) to facilitate calculation of Haptoglobin concentration in test specimens. • Draw the best smooth curve through these points to construct the standard curve. • Determine the concentrations of the test samples and controls from the standard curve by reading specimen values directly from the calibrator curve and then multiplying the interpolated value by the appropriate dilution factor. • Samples that have a signal greater than the highest standard, or fall on the non-linear part of the curve, should be further diluted in diluent buffer and re-analyzed. Waste Management Please refer to local legal requirements Quality Control Good laboratory practice suggests the use of control specimens to ensure proper assay performance. Laboratories should assess the Haptoglobin and CRP components of the Tri-Screen kit using Quality Control material. A separate set of additional Tri-Screen Quality Control sera are available specifically for use with this kit. In addition to values for both Haptoglobin and CRP at both Positive and Negative Lymphoma Levels, the use of this control material correlates with the Positive and Negative results range obtained when the results are input into the algorithm. Therefore the material acts to control both the diagnostic assay processes, the functioning of the algorithm and the overall result. This control may be purchased as a separate item (Catalogue no. TSC-501-CON). 4
    • It is recommended the controls be included in every assay. New lots of control material should be analysed in parallel with the control material in current use. Controls should be monitored and charted on a day-to-day basis to analyse values and trends. Storage and Stability The storage and stabilities for the Haptoglobin reagents and calibrators are as follows: 0 0 Unopened and stored at 2 C-8 C: Unopened Haptoglobin reagents are stable until the last day of the month of the expiration date printed on the product label. 0 0 1. Opened and stored at 2 C-8 C: Opened Haptoglobin reagents are stable until the last day of the month of the expiration date printed on the product label, if kept closed in their original containers, free from contamination and at the correct temperature. 2. On-board stability: Opened Haptoglobin reagents (excluding prepared calibrators) have on- o board stability at room temperature (20-25 C) for 1 week. o 3. Calibrators prepared are stable for 8 hours when stored at room temperature (20-25 C) in closed containers. 4. Protect all reagents from extreme heat or freezing. In order to ensure maximum stability of the Haptoglobin reagents on each automated chemistry analyser, it is important to use proper boats and anti-evaporation tray covers. Performance Characteristics Haptoglobin Standard curve 1 0.9 0.8 0.7 0.6 Abs 0.5 Standard curve 0.4 0.3 0.2 0.1 0 0 0.5 1 1.5 2 2.5 3 Haptoglobin concentration mg/ml Note: An example of a typical standard curve is presented above. This should not be used in determination of Haptoglobin. Intra assay Variation, Haptoglobin Assay( n=32 ) Mean Hp Standard Deviation Coefficient of Variation (%) Concentration (mg/ml) Low 0.59 0.02 5.3 High 1.30 0.10 6.3 Inter assay Variation( n=64 ) Mean Hp Standard Deviation Coefficient of Variation (%) Concentration (mg/ml) Low 0.59 0.02 5.7 High 1.26 0.10 4.1 5
    • Analytical SensitivityAnalytical sensitivity has been determined as 0.005 mg/ml Haptoglobin. This value wasdetermined by the addition of two standard deviations of the mean OD obtained when the zerocalibrator was assayed 32 times.Limitation of Test• Serum or plasma samples are recommended for use in this test. However, to eliminate potential discrepancies it is recommended that any study which starts with a particular matrix i.e. serum or plasma, should continue to use the same matrix for the duration of the investigation.• Mildly haemolysed samples may be used in the test. However, grossly haemolysed samples (haemoglobin >2.5 g/l) should be avoided as results may not be reliable.• Ensure that serum samples are collected prior to administration of steroids.Warnings and Precautions• Avoid contact with eyes, skin and clothing. Wash hands thoroughly after handling and when finished. Avoid ingestion of reagents. Never pipette by mouth and wear disposable latex gloves and eye protection where appropriate.• Reagent 2 contains reagents that may irritate the skin or mucous membranes. Any reagent which comes in contact with skin should be washed off with water immediately.• Some reagents contain thimerosal and may be toxic if ingested.Procedural• Do not use kit or individual reagents past their expiry date.• Do not mix or substitute reagents from different kit lot numbers.• Deviation from protocol provided may cause erroneous results.• Samples should be stored refrigerated, or frozen if they are not to be analysed shortly after collection. Avoid repeated freeze thaw cycles.• When possible avoid the use of haemolysed or lipaemic sera. If large amounts of particulate matter are present this should be removed by centrifugation prior to assay.• It is recommended that all calibrators and samples are run in duplicate. 0• Allow all reagents to come to room temperature (20 – 25 C) and mix well before use. 0• Avoid leaving reagents in direct sunlight and/or above 4 C for extended periods.• Cover or cap all reagents when not in use.• Always use clean, preferably disposable, glassware for all reagent preparation.• Care must be taken not to contaminate components and always use fresh tips for each sample and component.• In manual format ensure that the bottom surface of the well is clean and dry before reading. Ensure no bubbles are present in the wells prior to reading.• Before commencing the manual assay format, an identification and distribution plan should be established. It is also recommended labelling each strip to enable identification.• Read absorbances immediately after completion of the assay. Do not allow the calibration curve to over-develop and undergo a wavelength shift (change from blue to light brown colour). 6
    • Section 2: The CRP AssayAssay principleThe Canine CRP kit is a solid phase sandwich Immunoassay. Samples, including calibrators of knownCRP content bind to coated microwells. After washing to remove any unbound material the HRPlabeled Anti-Canine CRP antibody is added to each well. After again washing to remove any unboundmaterial TMB substrate solution is added. The intensity of the colour produced is proportional to theconcentration of CRP present in the original specimen.Components Supplied1. Coated microplate 1 x 96 well plate2. C-Reactive protein calibrator 1 x 1.5ml (Ready to use)3. Standard/sample diluent buffer 1 x 50ml (20x concentrate)4. Anti-canine CRP Conjugate 1 x 11ml (Ready to use)5. Wash concentrate 1 x 50ml (20x concentrate)6. TMB Substrate 1 x 11ml (Ready to use)7. Stop solution 1 x 11ml (Ready to use)Additional materials required1. Serum collection equipment.2. Microtiter plate reader capable of measurement at 450nm with reference at 630nm if available.3. Accurate micropipettes and disposable tips to deliver 0-10µl, 20-200µl and 200-1000µl.4. A repeat or multichannel pipette (50-200µl) for large assays.5. Deionized or distilled H2O.6. Plate washer (automated or manual).7. Graph paper: Standard or semi-log.8. Glass or plastic test tubes.9. Absorbent paper towels10. 96 well dust plate cover. o11. 37 C incubator.12. TimerStorage and Stability oThe kit components are stable when stored at 2-8 C until the expiry date indicated on the kit label.Safety• Never pipette by mouth.• Wear disposable latex gloves and eye protection where appropriate.• The stop solution and TMB substrate contain reagents that may irritate the skin or mucous membranes. Any reagent, which comes into contact with the skin, should be washed off with water immediately.Procedural• Do not use kit or individual reagents past their expiry date.• Do not mix or substitute reagents from different kit lot numbers.• Deviation from protocol provided may cause erroneous results.• Samples should be stored refrigerated, or frozen if they are not to be analysed shortly after collection. Avoid repeated freeze thaw cycles.• When possible avoid the use of haemolysed or lipaemic sera. If large amounts of particulate matter are present this should be removed by centrifugation prior to assay.• It is recommended that all calibrators and samples are run in duplicate. 0• Allow all reagents to come to room temperature (20 – 25 C) and mix well before use. 0• Avoid leaving reagents in direct sunlight and/or above 4 C for extended periods. 7
    • • Cover or cap all reagents when not in use.• Always use clean, preferably disposable, glassware for all reagent preparation.• Care must be taken not to contaminate components and always use fresh tips for each sample and component.• Before commencing the manual assay format, an identification and distribution plan should be established. It is also recommended labelling each strip to enable identification.Sample PreparationSpecimens should be collected by venipuncture into serum collection tubes. Blood samples may bekept for up to 24 hours before separation of serum. However, it is best to remove serum from the clot oas soon as possible after collection. In general, serum may be stored at 2-8 C for up to 24 hours or ostored frozen at –20 C for longer periods without loss of CRP. It is important that all refrigeratedsamples are brought to room temperature and mixed to assure accurate determination of the CRPconcentration.All samples should be diluted 1:500 in sample diluent buffer (1x) prior to assay by addition of 10ul ofsample to 5.0 ml diluent buffer (1x).Do not use grossly haemolysed or lipaemic samples.Reagent PreparationDiluent Buffer (1x)Dilute 1 volume of diluent buffer concentrate (20x) with 19 volumes of distilled water. Store both thediluent buffer concentrate and working diluent buffer (1x) in the refrigerator. Diluted diluent buffer is ostable for up to 2 weeks when stored at 4 C.Wash Buffer (1x)Dilute 1 volume of wash buffer concentrate (20x) with 19 volumes of distilled water. Store both thewash buffer concentrate and working wash buffer (1x) in the refrigerator. Diluted wash solution is ostable for up to 2 weeks when stored at 4 C.Calibration Curve PreparationLabel 6 tubes C1 to C6. To prepare the top calibrator, add 250ul of the calibrator supplied with the kitto tube C1 (see table 1). Add 250ul 1x diluent buffer to each of the remaining tubes (C2-C6) asdirected in table 1. The top calibrator is serially diluted 4 times (tubes C2 to C5) to provide the workingcalibrators as indicated in table 1 below. Tube C6 constitutes the assay blank and contains 1x diluentbuffer only.Table 1: Preparation of working calibration curve Tube No. CRP Volume of Volume of 1x Serial Concentration calibrator diluent buffer dilution C1 (Top 120ng/ml 250µl - - calibrator) C2 60ng/ml 250µl 250µl - C3 30ng/ml - 250µl 250µl of C2 C4 15ng/ml - 250µl 250µl of C3 C5 7.5ng/ml - 250µl 250µl of C4 C6 (Blank) Blank 250µl - 8
    • The range provided represents a CRP concentration of 3.75 – 60ug/ml when sample dilution of 1:500 is taken into account.Procedure1. Determine the number of 8-well strips needed for the assay. Re-bag extra strips, seal bag and store desiccated in a refrigerator.2. Add 100µl of the diluted sample or calibrator, in duplicate, to each well. µ o3. Cover the plate with a dust cover and incubate the plate for 15 minutes at 37 C.4. After incubation aspirate or decant and wash the plate four times with diluted wash buffer (400ul per well per wash). After the last wash tap the plate dry on absorbent paper.5. Add 100µl of conjugate to each of the wells. µ o6. Cover the plate with a dust cover and incubate the plate for 15 minutes at 37 C.7. After incubation aspirate or decant and wash the plate four times with diluted wash buffer (400ul per well per wash). After the last wash tap the plate dry on absorbent paper.8. Add 100µl of TMB Substrate. µ9. Cover the plate with a dust cover and incubate the plate for 15 minutes at room temperature.10. Add 100µl of stop solution and tap gently to mix. µ11. Read the absorbance of each well at 450nm using 630nm as a reference.Interpretation of Test Results1. Calculate the mean absorbance for each sample, control or calibrator.2. Plot the absorbance of the calibrators against the calibrator concentration on standard or semi- logarithmic graph paper. (If necessary, the background absorbance for the 0ng/ml may be subtracted from each of the data points, including the calibrators, unknowns and controls prior to plotting). Draw the best smooth curve through these points to construct the calibration curve. Determine the concentrations of the test samples and controls from the calibration curve by multiplying the interpolated value by the appropriate dilution factor. Samples that have a signal greater than the top calibrator, or fall on the non-linear part of the curve, should be further diluted in diluent buffer and re-analysed. Typical Data An example of a typical calibration curve is represented below. This should not be used in the determination of Canine CRP Canine CRP Calibration curve 2.5 2 Absorbance 450nm 1.5 1 0.5 0 0 50 100 150 Canine CRP conc ng/ml 9
    • Assay ReproducibilityTwo samples containing medium and low levels of Canine CRP were run in independent assays. Todetermine inter assay reproducibility the mean and the coefficient of variation (%CV) were calculated. Inter assay variation Control Level 1 Level 2 n 32 32 Mean (µg/ml) µ 14.9 34.6 Standard Deviation 1.2 2.7 %CV 8.2% 7.8%Two samples containing medium and low levels of Canine CRP were tested in a single assay. Toestablish intra assay reproducibility the mean and the coefficient of variation (%CV) were calculated. Intra assay Variation Control Level 1 Level 2 n 16 16 Mean (µg/ml) µ 15.4 35.8 Standard Deviation 1.1 2.3 %CV 6.9% 6.5%Limitations of TestThe use of this test for the analysis of plasma samples has not been fully investigated. Haemolysed orlipaemic samples should not be used in the test.Ensure that serum samples are collected prior to administration of steroids.Waste ManagementPlease refer to local legal requirementsQuality ControlGood laboratory practice suggests the use of control specimens to ensure proper assay performance.Laboratories should assess the Haptoglobin and CRP components of the Tri-Screen kit using QualityControl material. A separate set of additional Tri-Screen Quality Control sera are availablespecifically for use with this kit. In addition to values for both Haptoglobin and CRP at both Positiveand Negative Lymphoma Levels, the use of this control material correlates with the Positive andNegative results range obtained when the results are input into the algorithm. Therefore the materialacts to control both the diagnostic assay processes, the functioning of the algorithm and the overallresult. This control may be purchased as a separate item (Catalogue no. TSC-501-CON).It is recommended the controls be included in every assay. New lots of control material should beanalysed in parallel with the control material in current use. Controls should be monitored and chartedon a day-to-day basis to analyse values and trends. 10
    • Section 3: The Diagnostic AlgorithmWhen results for Haptoglobin and CRP are obtained for each individual sample (or Control)the diagnostic interpretation is performed by accessing the patented Tri-Screen algorithm which ishosted on our Registered User’s website at www.tri-screen.net.The procedure for accessing and obtaining a diagnostic report is as follows:The first time you purchase a Canine Lymphoma Kit, please visit the website and register as aregistered user. This will allow you to generate a unique user name and password which will allowyou access to the user’s area of the website where you can input your results to obtain a diagnosticreport. This is also designed to keep your own details, results and information confidential and secure.You are now registered and set up to input data on the Tri-Screen website, the next step is to performyour Haptoglobin and CRP assays and obtain results for both parameters. The same procedureapplies whether you are inputing patient samples or control serum samples.When you have obtained results, sign in on the website using your username and password.If you have forgotten either your user name or password, please follow the procedure listed on thesign in page to retrieve them.When you sign in you will then be taken to the input page.Here you will be asked to input the unique identification code for your kit which can be found on thelabel attached to the inside of the lid of the kit box.You will then have access to the results page: here you can see the results from the tests you havecarried out using this particular kit. You can also access stored or archived data or results andproduce a report by selecting criteria from the data. Instructions for doing this are on the web page.The web page will also show how many tests are remaining for the unique code number for the kit.Each kit performs a maximum of 42 tests in duplicate and there are 55 result inputs for each kit toallow for errors.Input the data for your test samples: Name Age Breed Gender Date Clincal Signs TreatmentAnd input the CRP and Haptoglobin results.Click “Calculate“The Algorithm will produce one of three results with regard to the Lymphoma Diagnosis: Positive Negative Repeat In Two WeeksPositive and Negative are self-explanatory.“Repeat In Two Weeks“ indicates that the result falls into arange which is considered inconclusive and the recommendation is that the test is repeated in twoweeks time.The Tri-Screen system of Haptoglobin, CRP and Algorithm produced a diagnostic efficiency forCanine Lymphoma of: Specificity: 93% Sensitivity: 85% 11
    • Users should be aware that within the limits of the studies carried out, False Positive and FalseNegative results may occur in a small percentage of cases and that diagnosticians and cliniciansshould use the results obtained in conjunction with other symptoms to make a diagnosis. Themanufacturers and providers cannot be held responsible for any loss, damage or injury caused as aresult of reliance on the results of the Tri-Screen assay system.Additional Products in the Tri-Screen RangeA specific Tri-Screen control material containing both CRP and Haptoglobin controls in the sameserum is available.This consists of 2 x 1ml controls:Positive: Contains Haptoglobin and CRP in the Positive Range when tested with the algorithm.Negative: Contains Haptoglobin and CRP in the Negative Range when tested with the algorithm.These controls should be treated as samples and a result obtained for both CRP and Haptoglobinwhich should then be entered on the website as a Control Sample.In addition to values for both Haptoglobin and CRP at both Positive and Negative Lymphoma Levels,the use of this control material correlates with the Positive and Negative results range obtained whenthe results are input into the algorithm. Therefore the material acts to control both the diagnosticassay processes, the functioning of the algorithm and the overall result.This allows for the Haptoglobin, CRP and Algorithm to be controlled as part of the process.The control is available from Tridelta Development Ltd. or your Local Distributor as:Catalogue No. TSC-501-CON Tri-Screen Canine Lymphoma Control Serum.Tri-Screen Canine Lymphoma Detection Kits are a joint venture product of:Tridelta Development Ltd. PetScreen Ltd.Unit 7 Block F BiocityMaynooth Business Campus Pennyfoot StreetMaynooth NottinghamCounty Kildare NG1 1GFIreland United KingdomTel: +353 (0)1 6290635 Tel: +44 (0) 115 9124430Fax: +353 (0)1 6290687 Fax: +44 (0) 800 6190280www.trideltaltd.com www.pet-screen.comThe dedicated Tri-Screen web site is at: www.tri-screen.netFor Sales & Marketing, please contact Tridelta Development Ltd. as above or byEmail to: sales@tri-screen.netFor Technical Support, please contact PetScreen Ltd. as above or byEmail to: technical@tri-screen.net 12