QUANTA Flash h-tTG IgA 701103
Contents
1. INOVA Diagnostics Inc 9900 Old Grove Road San Diego CA 92131 1638 USA 701100_nccls_EN Tel 1 858 586 9900 Fax 1 858 586 9911 Page 1 of 12 http www inovadx com Format to CLSI Standards GP2 A5 Formerly NCCLS Vol 26 No 12 Issue Date 08 16 2012 QUANTA FlashTM h tTG IgA 701103 For In Vitro Diagnostic Use Principles of the Procedure Recombinant h tTG is coated on to paramagnetic latex beads which are stored in the reagent cartridge under conditions that preserve the antigen in its reactive state When the assay cartridge is ready to be used for the first time a buffer solution is added to the tube containing the preserved beads and the beads are mixed with the buffer The reagent cartridge is then loaded onto the BIO FLASH A patient serum sample is prediluted by the instrument using sample buffer added to a disposable plastic cuvette Small amounts of the diluted patient serum the h tTG beads and the assay buffer are all combined into a second cuvette and mixed This cuvette is incubated at 37 C The beads are then magnetized and washed several times Isoluminol conjugated antibody is then added to the cuvette and incubated at 37 C Again the beads are magnetized and washed repeatedly The isoluminol conjugate produces a luminescent reaction when reagents Triggers are added to the cuvette The light produced from this reaction is measured as Relative Light Units RLU by the BIO FLASH optical system The RLU a2. is proportional to the amount of antibody The reportable range of the assay is 1 9 CU to 4965 5 CU If a patient result is less than 1 9 CU then the BIO FLASH system will report it as lt 1 9 CU Since this is less than 20 CU it is considered a negative result If a patient result is greater than 4965 5 CU then the BIO FLASH system will report it as gt 4965 5 CU This is considered a positive result The BIO FLASH software has an Auto Rerun option available If this option is selected the instrument will automatically rerun any sample that has a result gt 4965 5 CU by further diluting it by a factor of 10 and calculate the actual CU using this additional dilution factor Expected Values amp Specific Performance Characteristics The assay cutoff was determined by testing 446 clinically characterized samples single bleeds of patients who were clearly diagnosed with or without celiac disease and were not on a gluten free diet These samples 117 clinically positive and 329 clinically negative were used to adjust the cutoff to 20 CU to optimize sensitivity and specificity at 92 3 and 98 2 respectively in this training set Method Comparison with Predicate Device Samples for method comparison analysis included those samples from the clinical validation studies CD non CD and dermatitis herpetiformis patients that were within the reportable range of the assay These samples were tested on both the QUANTA Flash IgA h tTG and on the
3. Millan SA Haughton DJ Biggart JD et al Predictive value for coeliac disease of antibodies to gliadin endomysium and jejunum in patients attending for jejunal biopsy BMJ 202 211 1986 303 4 Valdimarsson T Franzen L Grodzinsky E et al Is small bowel biopsy necessary in adults with suspected celiac disease and IgA anti endomysial antibodies 100 positive predictive value for celiac disease in adults Digestive Diseases and Science 1163 1165 1991 41 5 Walker Smith JA Guandalini S Schmitz J et al Revised criteria for diagnosis of celiac disease Report of working group of European Society of Pediatric Gastroenterology and Nutrition ESPGAN Arch Diseases of Childhood 83 87 1996 65 6 Dieterich W Ehnis T Bauer M et al Identification of tissue transglutaminase as the autoantigen of celiac disease Nature Medicine 3 797 801 1997 909 911 1990 7 Sardy M Odenthal U Karpati S et al Recombinant human tissue transglutaminase ELISA for the diagnosis of gluten sensitive enteropathy Clin Chem 45 8 Sblattero D Berti I Trevisiol C et al Human recombinant tissue transglutaminase ELISA an innovative diagnostic assay for celiac disease Am J Gastroenterology 2142 2149 1999 95 9 Marietta EV Camilleri MJ Castro LA et al Transglutaminase autoantibodies in dermatitis herpetiformis and Celiac Sprue J Invest Dermatol 1253 1257 2000 128 10 Biosafety in Microb
4. U SD CV SD CV SD CV SD CV Pt 1 100 8 7 0 3 3 5 0 2 2 5 0 0 0 0 0 3 4 0 Pt 2 100 22 9 0 6 2 6 0 7 3 0 0 3 1 3 1 0 4 2 Pt 3 100 25 1 0 5 2 2 0 8 3 2 0 5 1 8 1 1 4 2 Pt 4 100 40 5 1 2 2 9 1 5 3 6 0 0 0 0 1 8 4 5 Pt 5 100 69 6 1 5 2 2 2 5 3 6 1 0 1 4 3 1 4 4 Pt 6 100 342 1 10 6 3 1 9 9 2 9 4 6 1 3 15 2 4 4 Pt 8 84 3476 1 224 3 6 5 277 4 8 0 171 6 4 9 395 8 11 4 Limitations of the Procedure 1 Not all patients with celiac disease or dermatitis herpetiformis are positive for IgA h tTG autoantibodies Additionally a negative h tTG IgA result in an untreated patient can often be explained by selective IgA deficiency a relatively frequent finding in celiac disease INOVA offers the QUANTA Flash h tTG IgG kit for these patients 2 Results of this assay should be used in conjunction with clinical findings and other serological tests 3 Failure to adequately resuspend the h tTG coated beads may yield lower values than if the beads are properly resuspended 4 The performance characteristics of this assay have not been established for matrices other than serum INOVA Diagnostics Inc 9900 Old Grove Road San Diego CA 92131 1638 USA 701100_nccls_EN Tel 1 858 586 9900 Fax 1 858 586 9911 Page 7 of 12 http www inovadx com QUANTA Flash h tTG IgA 701101 Calibrators For In Vitro Diagnostic Use Principles of the Pro
5. ainer click the Bulks Inventory F9 button upper right corner In the Inventory Bulks screen click the Sys Rinse button In the new window Add System Rinse Remove bottles click Next Follow the instructions in the new window Add System Rinse Add bottle Once the barcode has been accepted click Finish if necessary 5 To empty the Fluid Waste Container from the Inventory Bulks screen click the Fluid Waste button Remove and dispose of the fluid waste Click Next Once the empty bottle has been replaced click Finish Programming and Running Samples 1 Press the Worklist button at the top of the screen and select the Racks tab at the bottom 2 Select the sample rack to be used by highlighting the rack on the screen or by scanning its barcode with the handheld barcode reader Scan or type in the sample name select the sample type container type tube cup and select h tTG_IgA from the assay panel Repeat these steps for all samples 3 Load the samples into the selected positions in the sample rack and load the rack into the sample carousel of the instrument 4 If all required materials are onboard the instrument the start icon will be available in green at the top of the screen Press the start icon to begin the run INOVA Diagnostics Inc 9900 Old Grove Road San Diego CA 92131 1638 USA 701100_nccls_EN Tel 1 858 586 9900 Fax 1 858 586 9911 Page 4 of 12 http www inovadx com Reagent Cartridge Preparatio
6. cedure The QUANTA Flash h tTG IgA Calibrators are intended for use with the QUANTA Flash h tTG IgA chemiluminescent immunoassay CIA on the BIO FLASH instrument Each calibrator establishes a point of reference for the working curve that is used to determine Chemiluminescent Units CU values in the measurement of IgA anti h tTG antibodies in serum The QUANTA Flash h tTG IgA CIA utilizes a predefined lot specific Master Curve that is stored in the reagent cartridge barcode The QUANTA Flash h tTG IgA Calibrators are designed to produce an instrument specific Working Curve from the parameters of the Master Curve with a decision point based on the performance characteristics and clinical evaluation of the QUANTA Flash h tTG IgA CIA Calibrators Reagents 1 QUANTA Flash h tTG IgA Calibrator 1 Two 2 barcode labeled tubes with buffer containing human serum IgA antibodies to h tTG prediluted ready to use 0 3mL blush colored containing buffer protein stabilizers and preservatives 2 QUANTA Flash h tTG IgA Calibrator 2 Two 2 barcode labeled tubes with buffer containing human serum IgA antibodies to h tTG prediluted ready to use 0 3mL blush colored containing buffer protein stabilizers and preservatives Warnings 1 WARNING The calibrators contain a chemical 0 02 chloramphenicol known to the State of California to cause cancer 2 Sodium Azide is used as a preservative Sodium Azide is a poison and may be toxic if ingested or absorb
7. ed through the skin or eyes Sodium azide may react with lead or copper plumbing to form potentially explosive metal azides Flush sinks if used for reagent disposal with large volumes of water to prevent azide build up 3 All human source material used in the preparation of calibrators for this product has been tested and found negative for antibody to HIV HBsAg and HCV by FDA cleared methods No test method however can offer complete assurance that HIV HBV HCV or other infectious agents are absent Therefore the QUANTA Flash h tTG IgA Calibrators should be handled in the same manner as potentially infectious material 4 Use appropriate personal protective equipment while working with the reagents provided 10 5 Spilled reagents should be cleaned up immediately Observe all federal state and local environmental regulations when disposing of wastes Precautions 1 This product is for In Vitro Diagnostic Use 2 The QUANTA Flash h tTG IgA Calibrators are for use with the QUANTA Flash h tTG IgA assay 3 Do not transfer the calibrator reagents to secondary tubes The barcodes on the tubes are used by the instrument to match the calibrators to the proper assay type 4 Once a calibrator tube is opened it is good for up to 8 hours or 4 calibrations after which the reagent must be discarded 5 Chemical contamination of the reagents can result from improper cleaning or rinsing of the instrument Residues from common laboratory chemicals
8. ee holes 5 Place the reagent cartridge into any open slot on the reagent carousel of the BIO FLASH instrument Assay Procedure Assay Calibration 1 Each new lot of reagent cartridge must be calibrated prior to first time use The software will not allow a new lot to be used until it is calibrated 2 Refer to the section titled QUANTA Flash h tTG IgA Calibrators 701101 of this Direction Insert for detailed instructions of how to calibrate the reagent cartridge 3 Once the calibration is validated the reagent cartridge lot on which the calibration was performed is ready for use INOVA Diagnostics Inc 9900 Old Grove Road San Diego CA 92131 1638 USA 701100_nccls_EN Tel 1 858 586 9900 Fax 1 858 586 9911 Page 5 of 12 http www inovadx com Calculation of Results A five point Master Curve is produced at INOVA for each new lot of QUANTA Flash h tTG IgA This four parameter logistic curve is encoded in the barcode of each reagent cartridge Once a reagent cartridge has been calibrated a machine specific working curve will be used to convert the RLU to CU The IgA antibody reactivity for h tTG can then be classified according to the table below Reactivity Negative lt 20 CU Weak Positive 20 30 Positive gt 30 Reactivity in CU is directly related to the titer of the autoantibody in the patient sample Increases and decreases in patient antibody concentrations will be reflected in a corresponding rise or fall in CU which
9. for screening patients with suspected gluten sensitive enteropathy as well as for monitoring dietary compliance 1 2 3 5 The European Society of Pediatric Gastroenterology and Nutrition has recommended the use of antibody markers such as anti gliadin and anti endomysial antibodies to reduce the number of intestinal biopsies needed to make a diagnosis The endomysial antigen has been identified as the protein cross linking enzyme tTG 5 6 The h tTG antigen has been produced by recombinant technology and may have certain advantages compared with the antigen from guinea pig liver Dermatitis herpetiformis is a skin disease that as with celiac disease is caused by ingestion of wheat protein A majority of patients with DH have jejunal villous atrophy identical to that found in celiac disease and strict gluten free diet improves both gut and skin lesions 7 8 1 2 9 Current serological methods such as the endomysial native gliadin and tTG assays exhibit lower performance when testing for DH with sensitivities ranging from only 60 75 9 compared to sensitivities greater than 95 for celiac disease 3 8 INOVA Diagnostics Inc 9900 Old Grove Road San Diego CA 92131 1638 USA 701100_nccls_EN Tel 1 858 586 9900 Fax 1 858 586 9911 Page 2 of 12 http www inovadx com Reagents 1 QUANTA Flash h tTG IgA reagent cartridge contains the following reagents for 50 tests a h tTG coated paramagnetic beads preserved prior to first t
10. ge Refer to the user s manual provided with the BIO FLASH system for detailed operating instructions of the BIO FLASH chemiluminescent analyzer and the BIO FLASH software Traceability There is currently no recognized international standard for the measurement of IgA anti human tissue transglutaminase antibodies Limitations These controls are designed for 15 uses The label of each control tube has a row of 15 boxes that may be checked off so as to track the number of uses The total time the calibrator tubes can be uncapped onboard the instrument is 2 hours or 10 minutes per use If the controls are left uncapped onboard for any longer period of time they should be discarded Using the same control tubes for more than 15 uses and or more than 2 hours total can result in erroneous results 701100_nccls_EN Page 11 of 12 Symbols Used In Vitro diagnostic medical device Consult instructions for use Temperature limitation Do not reuse Biological risks Batch code Catalog number Use by Manufacturer Authorized representative Contains sufficient for lt n gt tests Control Calibrator 1 Calibrator 2 Recycle paper box This end up 701100_nccls_EN Page 12 of 12 References 1 Trier JS Celiac Sprue N Engl J Med 325 2 Strober W Gluten sensitive enterophy A nonallergic immune hypersensitivity of the gastrointestinal tract J Allergy Clin Immunol 1709 1719 1991 78 3 Mc
11. http www inovadx com Quality Control The QUANTA Flash h tTG IgA Controls sold separately INOVA Item Number 701102 contains both h tTG IgA Positive and Negative Controls Refer to the section titled QUANTA Flash h tTG IgA Controls 701102 of this Direction Insert for detailed instructions on how to input the unit value and standard deviation of each control into the software as well as how to run the controls Controls are recommended to be run once every day that the assay is used Interpretation of Results The QUANTA Flash Assay is capable of detecting small differences in patient populations Each laboratory should establish its own normal range based upon its own controls and patient population according to their own established procedures It is suggested that the results reported by the laboratory should include the statement The following results were obtained with the INOVA QUANTA Flash h tTG IgA chemiluminescent immunoassay Values obtained with different manufacturers assay methods may not be used interchangeably The magnitude of the reported IgA autoantibody levels cannot always be correlated to an endpoint titer Procedure Method Before you start Using the BIO FLASH Chemiluminescent Analyzer 1 Refer to the user s manual provided with the BIO FLASH system for detailed operating instructions of the BIO FLASH chemiluminescent analyzer and the BIO FLASH software For additional information and for troubleshooting problems
12. ime use b Assay buffer colored pink containing Tris buffered saline Tween 20 protein stabilizers and preservatives c Tracer IgA Isoluminol labeled anti human IgA antibody containing buffer protein stabilizers and preservative d Sample buffer phosphate buffered saline with Tween 20 2 Resuspension buffer 1 vial colored pink containing buffer protein stabilizers and preservatives Materials provided 1 QUANTA Flash h tTG IgA reagent cartridge 1 3mL resuspension buffer 1 Transfer pipet Additional Materials Required But Not Provided BIO FLASH instrument with operating computer BIO FLASH System Rinse Part Number 3000 8205 BIO FLASH Triggers Part Number 3000 8204 BIO FLASH Cuvettes Part Number 3000 8206 QUANTA Flash h tTG IgA Calibrators Part Number 701101 QUANTA Flash h tTG IgA Controls Part Number 701102 Specimen This procedure should be performed with a serum specimen Microbially contaminated heat treated or specimens containing visible particulates should not be used Grossly hemolyzed or iteric serum should not be used Following collection the serum should be separated from the clot CLSI Document H18 A3 recommends the following storage conditions for samples 1 Store samples at room temperature no longer than 8 hours 2 If the assay will not be completed within 8 hours refrigerate the sample at 2 8 C 3 If the assay will not be completed within 48 hours or for shipment of the sample freeze a
13. iological and Biomedical Laboratories Centers for Disease Control National Institutes of Health Fifth Edition 2007 332 335 2007 Manufactured By INOVA Diagnostics Inc 9900 Old Grove Road San Diego CA 92131 United States of America Technical Service U S amp Canada Only 877 829 4745 support inovadx com 621100 Rev 1 2011 JUL
14. l tube should be used 701100_nccls_EN Page 10 of 12 Procedure New Lot 1 Prior to using a new lot of QUANTA Flash h tTG IgA Controls for the first time the name lot expiration value or dose and target SD information must be entered into the software 2 From the Instrument Summary screen click the Choose more options Ctrl M arrow button Select QC Ctrl F2 Highlight the tTG_IgA assay in the column on the left Then highlight the appropriate control material on the right either TTGAN for the Negative Control or TTGAP for the Positive Control Click the New QC Lot button 3 A lot specific data sheet is included with each Control set Enter the information from this data sheet into the software This should include the name lot number expiration target dose and target SD Click Save Perform this process for both controls 4 It is recommended that the QUANTA Flash h tTG IgA Controls be used once each day that the assay will be used 5 Each control must be gently mixed before use to insure homogeneity Avoid foam formation as bubbles may interfere with the instruments liquid level detection Uncap each control tube and place both into a sample rack with the barcodes facing forward through the gaps in the rack Place the sample rack into the sample carousel of the BIO FLASH instrument and close the door The instrument will read the barcodes on the control tubes and identify the required reagent cartrid
15. lash h tTG IgA Controls should be handled in the same manner as potentially infectious material 4 Use appropriate personal protective equipment while working with the reagents provided 10 5 Spilled reagents should be cleaned up immediately Observe all federal state and local environmental regulations when disposing of wastes Precautions 1 This product is for In Vitro Diagnostic Use 2 The QUANTA Flash h tTG IgA Controls are for use with the QUANTA Flash h tTG IgA assay 3 Do not transfer the control reagents to secondary tubes The barcodes on the tubes are used by the instrument to identify the control 4 Once opened each control tube is good for up to 15 uses with a maximum time of 10 minutes onboard the instrument per use 5 Chemical contamination of the reagents can result from improper cleaning or rinsing of the instrument Residues from common laboratory chemicals such as formalin bleach ethanol or detergent can cause interference in the assay Be sure to follow the recommended cleaning procedure of the instrument as outlined in the BIO FLASH user s manual Storage Conditions 1 Store unopened controls at 2 8 C Do not freeze Reagents are stable until the expiration date when stored and handled as directed 2 Opened controls can be used for up to 15 times with a maximum time of 10 minutes onboard the instrument per use If either of these limits is exceeded the control should be discarded and a new contro
16. n The first time the reagent cartridge is to be used the storage seals on the reagent tubes must be pierced and the h tTG coated beads must be mixed with resuspension buffer 1 Place the reagent cartridge on a solid surface Hold the reagent cartridge in place with one hand With your other hand firmly grasp the red pull tab on the back of the reagent cartridge and pull it out completely 2 Press the two tabs on the sides of the piercing cap grey part and apply pressure to the top portion of the reagent cartridge until it snaps down into a locked position The tabs should no longer be visible 3 Resuspend the kit reagents a Uncap the resuspension buffer vial and collect fluid into the transfer pipette provided The entire contents of the vial will be used b Slide the door in the reagent cartridge lid to the open position by gently pressing the narrow side on the reagent cartridge and hold it in this position Analytically transfer the entire contents of the vial into the bead reagent tube through the one single hole on the top of the reagent cartridge c Mix the contents of the bead reagent tube by aspirating and dispensing the liquid at least 30 times If visible clumps of beads are observed continue to mix the solution for another 30 times d Be sure to dispense all the liquid before removing the pipette from the tube and discarding it 4 Peel the sticker off the top of the reagent cartridge to reveal the other thr
17. on and accuracy of the assay at moderate to high antibody levels The QUANTA Flash h tTG IgA Controls are intended for quality control purposes of the QUANTA Flash h tTG IgA chemiluminescent immunoassay CIA kit run on a BIO FLASH instrument Reagents 1 QUANTA Flash h tTG IgA Negative Control Two 2 barcode labeled tubes with buffer containing human serum IgA antibodies to h tTG prediluted ready to use 0 5mL containing buffer protein stabilizers and preservatives 2 QUANTA Flash h tTG IgA Positive Control Two 2 barcode labeled tubes with buffer containing human serum IgA antibodies to h tTG prediluted ready to use 0 5mL containing buffer protein stabilizers and preservatives Warnings 1 WARNING The controls contain a chemical 0 02 chloramphenicol known to the State of California to cause cancer 2 Sodium Azide is used as a preservative Sodium Azide is a poison and may be toxic if ingested or absorbed through the skin or eyes Sodium azide may react with lead or copper plumbing to form potentially explosive metal azides Flush sinks if used for reagent disposal with large volumes of water to prevent azide build up 3 All human source material used in the preparation of controls for this product has been tested and found negative for antibody to HIV HBsAg and HCV by FDA cleared methods No test method however can offer complete assurance that HIV HBV HCV or other infectious agents are absent Therefore the QUANTA F
18. predicate ELISA Method Comparison N 140 h tTG IgA ELISA Percent Agreement 95 confidence Positive Negative Total QUANTA Flash h tTG IgA CIA Positive 69 2 71 Pos Agree 100 94 7 100 Negative 0 69 69 Neg Agree 97 2 90 3 99 2 Total 69 71 140 Total Agree 99 1 One sample was from a blood donor who was high negative on the h tTG IgA ELISA and the other was from a dermatitis herpetiformis patient Clinical Sensitivity and Specificity The clinical validation study included 200 normal blood donors 71 non celiac disease controls 77 samples from a tTG workshop 27 CD and 50 non CD controls and 29 additional CD samples from the INOVA serum library These samples were tested with the QUANTA Flash h tTG IgA kit The results of this testing are shown below Clinical N 371 Diagnosis Sensitivity and Specificity 95 confidence CD Not CD Total QUANTA Flash h tTG IgA CIA Positive 47 6 53 Sensitivity 94 0 83 5 98 7 Negative 3 315 318 Specificity 98 1 96 0 99 3 Total 50 321 371 These came from 4 blood donors 3 of whom were positive by ELISA and from 2 people who were positive for antibodies to H pylori and thyroglobulin respectively All three samples were also negative by the h tTG IgA ELISA INOVA Diagnostics Inc 9900 Old Grove Road San Diego CA 92131 1638 USA 701100_nccls_EN Tel 1 858 586 9900 Fax 1 858 586 9911 Page 6 of 12 http
19. re proportional to the amount of bound isoluminol conjugate which in turn is proportional to the amount of IgA anti h tTG antibodies bound to the h tTG on the beads instrument The QUANTA Flash h tTG IgA assay utilizes a predefined lot specific Master Curve that is uploaded into the instrument through the reagent cartridge barcode Based on the results of running two calibrators an instrument specific Working Curve is created which is used to calculate chemiluminescent units CU from the RLU obtained for each patient The QUANTA Flash h tTG IgA is a chemiluminescent immunoassay CIA for the semi quantitative detection of IgA anti human tissue transglutaminase h tTG antibodies in human serum The presence of IgA anti h tTG antibodies in conjunction with clinical findings and other laboratory tests can aid in the diagnosis of the gluten sensitive enteropathies celiac disease CD and dermatitis herpetiformis DH Celiac disease is a chronic condition whose main features include inflammation and characteristic flattening of intestinal mucosa resulting in a malabsorption syndrome known as a gluten sensitive enteropathy The exact etiology of the disease remains unknown but gliadin the alcohol soluble fraction of wheat gluten is clearly the toxic agent Originally a series of intestinal biopsies was used to diagnose celiac disease More recently serological testing for anti gliadin anti endomysial and anti tTG antibodies has been suggested
20. such as formalin bleach ethanol or detergent can cause interference in the assay Be sure to follow the recommended cleaning procedure of the instrument as outlined in the BIO FLASH user s manual 701100_nccls_EN Page 8 of 12 Storage Conditions 1 Store unopened calibrators at 2 8 C Do not freeze Reagents are stable until the expiration date when stored and handled as directed 2 Opened calibrators must be discarded after 8 hours Traceability There is currently no recognized international standard for the measurement of IgA anti human tissue transglutaminase antibodies Limitations These calibrators are designed for 4 calibrations The total time the calibrator tubes can be uncapped onboard the instrument is 8 hours If the calibrators are left uncapped onboard for any longer period of time they should be discarded Using the same calibrator tubes for more than 4 calibrations and or more than 8 hours can result in improper calibration of the assay which in turn could give erroneous results 701100_nccls_EN Page 9 of 12 QUANTA Flash h tTG IgA 701102 Controls For In Vitro Diagnostic Use Principles of the Procedure The QUANTA Flash h tTG IgA Controls are made up of a Negative Control and a Positive Control Each contains a different amount of IgA anti h tTG antibodies The Negative Control is designed to assess precision and accuracy of the assay at very low antibody levels The Positive Control is designed to assess precisi
21. t 20 C or lower Frozen specimens must be mixed well after thawing and prior to testing Special Safety Precautions Storage Conditions 1 Store unopened reagent cartridges and resuspension buffer at 2 8 C Do not freeze Reagents are stable until the expiration date when stored and handled as directed 2 Opened reagent cartridges should be stored onboard the instrument and are stable for a total of 20 days after which time they must be discarded The BIO FLASH software monitors the expiration dates of the onboard cartridges as well as the reagent cartridge lots Procedural Notes Warnings 1 WARNING The assay buffer contains a chemical 0 02 chloramphenicol known to the State of California to cause cancer 2 Sodium Azide is used as a preservative Sodium Azide is a poison and may be toxic if ingested or absorbed through the skin or eyes Sodium azide may react with lead or copper plumbing to form potentially explosive metal azides Flush sinks if used for reagent disposal with large volumes of water to prevent azide build up 3 Use appropriate personal protective equipment while working with the reagents provided 4 Spilled reagents should be cleaned up immediately Observe all federal state and local environmental regulations when disposing of wastes Precautions SEE WARNINGS INOVA Diagnostics Inc 9900 Old Grove Road San Diego CA 92131 1638 USA 701100_nccls_EN Tel 1 858 586 9900 Fax 1 858 586 9911 Page 3 of 12
22. with this assay contact INOVA Diagnostics Inc technical service at the address or telephone number found at the end of this Direction Insert 2 To empty the solid waste container open the waste drawer Remove the solid waste container and dispose of the solid non hazardous waste used cuvettes Replace the solid waste container close the waste drawer and click Yes in the Empty Waste Drawer window 3 To replace the triggers click the Bulks Inventory F9 button upper right a In the Inventory Bulks screen click the Triggers button on the left A new window will pop up titled Add Triggers Remove old bottles b Open and remove the waste drawer on the BIO FLASH instrument Dispose of any cuvettes in the dry waste drawer Click Yes on the Empty Waste Drawer window Remove the trigger bottles from their holders and click the Next button Unscrew the old trigger bottles from their caps and replace with new triggers Be sure to do them one at a time and match the color coded caps white to white and red to red c Follow the instructions in the new window Add Triggers Add Trigger 2 bottle Once the barcode has been accepted place Trigger 2 into the color coded white holder Click Next d Follow the instructions in the window Add Triggers Add Trigger 1 bottle Once the barcode has been accepted place Trigger 1 into the color coded red holder Click Finish Replace and close the waste drawer 4 To replace the System Rinse cont
23. www inovadx com Results from 25 patients with dermatitis herpetiformis are shown in the table below Dermatitis Herpetiformis N 25 Diagnosis Analysis 95 confidence DH Not DH Total QUANTA Flash h tTG IgA CIA Positive 20 0 20 Sensitivity 80 0 59 3 93 2 Negative 5 0 5 Total 25 0 25 These 5 samples were also negative by the h tTG IgA ELISA Limits of Detection Linear and Reportable Ranges Lower Limit of Detection The lower limit of detection of this assay according to CLSI EP17 A is approximately 465 RLU which is equivalent to 0 3 CU The upper limit of detection is about 1 000 000 RLU The entire reportable range from 1 9 CU to 4965 5 CU is linear A linearity study was performed according to CLSI EP6 A and the data are summarized below Sample Test Range CU Slope 95 CI Y intercept 95 CI R 1 1 9 45 4 1 0 0 95 1 05 0 93 0 26 2 2 1 000 2 2 8 118 3 1 03 0 99 1 06 0 68 1 38 2 7 1 000 3 3 0 141 3 0 99 0 95 1 02 1 05 1 46 3 56 1 000 4 17 6 724 7 1 02 0 98 1 06 7 81 7 25 22 87 1 000 5 2 2 2699 0 1 05 1 0 1 09 31 18 18 39 80 76 1 000 6 10 0 5428 0 0 92 0 86 0 98 100 9 267 2 65 5 0 990 Precision and Reproducibility Precision of the QUANTA Flash h tTG IgA assay was evaluated by running 7 patients in accordance with CLSI EP5 A2 and the data are summarized below Within Run Between Run Between Day Total Sample N Mean C
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