QUANTA Plex ENA Profile 5 708920
Contents
1. cutoff is 3 1 SD above the SD above the average All one hundred sixty of the normal samples were negative on the RNP portion of the QUANTA Plex test The 33 One hundred fifty seven of the normal samples were negative on the Scl 70 portion of the QUANTA Plex test The average value was 2 3 LU with a SD of 2 4 The cutoff is 7 4 SD above the average INOVA ENA Profile 5 Sm 244 Comparison between QUANTA Plex and ELISA Assays Negative To determine the positive and negative agreement of the assays in clinically defined patient samples 288 patients Positive with either SLE Sjogren s syndrome or scleroderma were tested by the QUANTA Plex ENA Profile 5 technique average and the 5 corresponding ELISAs SLE SS and Scl n 288 Sm ELISA 96 2 the same Negative Positive 2 were low positive and 2 were a moderate positive 6 were low positive and 1 was a moderate positive SLE SS and Scl n 284 INOVA ENA Profile 5 RNP RNP ELISA Negative Positive 94 0 the same Negative 203 0 Positive 17 64 4 samples were not tested because of insufficient volume 11 were low positive 2 were moderate and 4 were high SLE SS and Scl n 288 INOVA ENA Profile 5 SS A 52 and SS A 60 SS A ELISA Negative Positive 97 6 the same Negative 205 2 Positive 5 76 Both were low positive 1 was low positive2. 4 were moderate SLE SS and Scl n 288 INOVA ENA Profile 5 SS B SS B ELISA Negative Positive 97 9 the same Negative 255 1 Positive 5 76 This was low positive 4 were low positive and 1 was moderate SLE SS and Scl n 288 INOVA ENA Profile 5 Scl 70 Scl 70 ELISA Negative Positive 96 2 the same Negative 241 ik Positive 10 36 This was low positive 7 were low positive 2 were moderate and 1 was high NCCLS 708920 Page 6 of 8 1 2 3 gt Werfen Group Diagnostics Inc Positive Negative and Total Percent Agreement All the data above plus data from patients with rheumatoid arthritis were used to calculate the relative sensitivity of each QUANTA Plex test to its corresponding ELISA All Samples Both Both Pos ELISA Neg ELISA Pos Relative Relative Percent N 460 Neg Q Plex Pos Q Plex Neg Sensitivity Specificity Agreement sm 416 33 4 7 83 99 97 6 RNP 374 64 0 18 18 100 96 1 SS A 375 76 4 5 94 99 98 0 SS B 426 27 2 5 84 99 98 5 Scl 70 409 38 2 11 78 99 97 2 N 456 for RNP 4 samples were not tested on ELISA due to insufficient volume Precision and Reproducibility Inter assay and Intra assay variation For inter assay variation a number of samples were assayed in 6 tests run on different days The variation in two different samples for each test specificity is listed in the table below For intra assay variation a
3. Format to CLSI Standards GP2 A5 Formerly NCCLS Vol 26 No 12 Issue Date 10 15 09 708920 TM QUANTA Plex ENA Profile 5 Native Sm RNP and Scl 70 from calf thymus and recombinant human SS B are each bound to different fluorescently colored beads Because it has been reported that autoantibodies to both SS A 52 and SS A 60 native SS A 60 from calf thymus and recombinant SS A 52 are used on separate colored beads The six different antigen coated beads are mixed together and put into wells of a microwell plate under conditions that preserve the antigens in their reactive state Pre diluted controls and diluted patient sera For n Vitro Diagnostic Use antigens are diagnostically important Luminex flow analyzer This flow analyzer can discriminate the color of each bead from the others as well as measure the fluorescent intensity of the conjugate on each bead The conjugate s fluorescent intensity is proportional to the amount of labeled anti human IgG bound to the patient autoantibodies on the bead Each antigen can be semi quantitated by comparing the fluorescent intensity of the patient sample with the fluorescence of the it is by no means a specific CLIA Complexity High Principles of the Procedure are added to separate microwells allowing any Sm RNP SS A 52 SS A 60 SS B and Scl 70 autoantibodies present to bind to the immobilized antigen Then an anti human IgG conjugated to a fluorescent probe is added to correspondin
4. Page 7 of 8 The performance characteristics of this assay have not been established for matrices other than serum Tan EM et al The 1982 Revised Criteria for the Classification of Systemic Lupus Erythematosus Arthritis B or Scl 70 antibodies Failure to maintain consistent reagent addition timing may result in increased front to back assay variation 5 6 7 Arthritis and Rheumatism 24 323 358 1995 References 1 2 and Rheumatism 25 1271 1277 1982 Jonsson R Haga HJ and Gordon TP Current concepts on diagnosis autoantibodies and therapy in Sj gren s syndrome Scand J Rheumatol 29 341 348 2000 3 Walker JG and Fritzler MJ Update on autoantibodies in systemic sclerosis Curr Opin Rheumatol 19 580 Amigues JM Cantagrel A Abbal M and Mazieres B Comparative study of 4 diagnosis criteria sets for mixed connective tissue disease in patients with anti RNP antibodies Autoimmunity Group of the Hospitals of 5 Frank MB V McCubbin E Trieu Y Wu DA Isenberg IN Targoff The association of anti Ro52 Biosafety in Microbiological and Biomedical Laboratories Center for Disease Control National Institute of 858 586 9900 628920 Rev 8 Werfen Group Diagnostics inc 4 591 2007 Toulouse J Rheumatol 23 2055 2062 1996 autoantibodies with myositis and scleroderma autoantibodies J Autoimmun 12 137 142 1999 Martins TB Burlingame R von Muhlen CA et al Evaluation of multiplexed fluorescent microsphere
5. Positive 1 vial of buffer containing preservative and human serum antibodies to Sm RNP 4 5 HRP Sample Diluent 1 vial colored pink containing Tris buffered saline Tween 20 protein stabilizers and Werfen Group Diagnostics Inc Reagents continued preservatives 50mL Fluorescently labeled IgG Conjugate goat anti human IgG fc specific 1 amber vial lyophilized powder SS A 52 SS A 60 SS B and Scl 70 antigens prediluted 1 2mL containing buffer protein stabilizers and preservatives Refer to the Methods section for reconstitution QUANTA Plex Conjugate Diluent 1 vial colored pink containing buffer protein stabilizers and 6 instructions 7 ENA Profile 5 microwell plate 12 1 x 8 microwell strips with holder preservatives 7mL 1 2mL prediluted ready to use QUANTA Plex Negative Control 1 2mL prediluted ready to use ENA Profile 5 Calibrator Materials provided 1 2mL prediluted ready to use ENA Profile 5 Positive Bottle of lyophilized Fluorescent Conjugate goat anti human IgG 1 1 1 1 1 50mL HRP Sample Diluent 1 1 7mL QUANTA Plex Conjugate Diluent Additional Materials Required But Not Provided Sheath Fluid for Luminex flow analyzer Micropipet to deliver 5 and 500uL Disposable micropipet tips Test tubes for patient sample dilutions 1 to 4mL volume Distilled or deionized water Luminex flow analyzer 8 channel Electronic pipet to deliver 5 30 45 50 and 60uL or automated pipet
6. bottle using standard aseptic conditions and good laboratory techniques Remove only the amount of conjugate from the bottle necessary for the assay TO AVOID POTENTIAL MICROBIAL the incubation period AND OR CHEMICAL CONTAMINATION NEVER RETURN UNUSED CONJUGATE TO THE BOTTLE Incubate the microwell strips for 30 minutes at room temperature on a level surface and away from direct sunlight The incubation time begins after the first conjugate addition Within one hour after completion of the 30 minute fluorescent conjugate incubation read the ENA Profile 5 7 plate on the Luminex as detailed in the section above Using the Luminex Flow Analyzer The FIA is very sensitive to technique and is capable of detecting small differences in patient populations Each the laboratory should include the statement The following results were Reporting Results Interpretation of Results laboratory should establish its own normal range based upon its own techniques controls equipment and patient population according to their own established procedures It is suggested that the results reported by obtained with the INOVA QUANTA Plex ENA Profile 5 Values obtained with different manufacturers assay methods may not be used interchangeably The magnitude of the reported IgG autoantibody levels cannot always be correlated to an endpoint titer The MFIs for all controls and patient samples for each antigen are first determined The reactiv
7. crowells Because the samples are read sequentially at a rate of approximately 1 sample every 19 seconds or one 8 well strip in approximately 2 2 minutes by the Luminex the patient samples and also Sample Diluent to the first four microwells as these will contain the QUANTA Plex Negative Control the ENA Profile 5 Calibrator in duplicate and the ENA Profile 5 Positive Control Do not add the diluted patient 1 Add 45uL of HRP Sample Diluent to each microwell that will contain a patient sample Do not add HRP 2 Maintain one of the following timing sequence when adding controls samples and conjugate to the samples to the microwells at this time the conjugate must be added to the microwells at this rate to minimize any front to back assay variation If the controls samples or the conjugate are added one at a time stagger each addition of these to the next microwell by 19 seconds If controls samples or the conjugate are added 8 at a time to a strip stagger each addition of any of these to the next strip by 2 minutes Both of these timing schemes will take approximately 30 minutes for the addition of the samples to all 12 strips of an entire plate and will minimize Vortex then add 50uL of each of the following The pre diluted QUANTA Plex Negative Control to the first microwell the ENA Profile 5 Calibrator to the second and third microwells and the ENA Profile 5 Positive Control to the fourth microwell An electronic pipet
8. e the accuracy and reproducibility of the pipetting technique the reproducibility of the mixing technique the Luminex flow analyzer used to measure the results and the length of the incubation times during the assay Careful attention to consistency is required to obtain accurate and Strict adherence to the protocol is recommended Incomplete resealing of the zip lock pouch containing microwell strips and desiccants will result in antigen degradation and poor precision Unacceptably low fluorescence may be observed following multiple uses from a single bottle of fluorescent conjugate over a period of time It is important to follow all recommended fluorescent conjugate handling procedures to prevent this occurrence The ENA Profile 5 Calibrator and Positive Control and the QUANTA Plex Negative Control should be run reproducible results 8 Chemical contamination of the fluorescent conjugate can result from improper cleaning or rinsing of equipment or instruments Residues from common laboratory chemicals such as formalin bleach ethanol or detergent will cause degradation of the fluorescent conjugate over time Thoroughly rinse all equipment or instruments with distilled or deionized water after the use of chemical cleaners disinfectants Quality Control with every batch of samples to ensure that all reagents and procedures have performed properly prediluted they do not control for procedural methods associated with specimen diluti
9. ed by comparison to commercially available ELISA tests from INOVA Diagnostics Inc Results of the ELISAs and each of the QUANTA Plex ENA Profile 5 tests were determined to be positive if the patient NCCLS 708920 Page 5 of 8 Expected Values sample was greater than or equal to 20 LU and negative if less than 20 LU Diagnostics Inc Normal Range One hundred fifty nine of the normal samples were negative on the SS B portion of the QUANTA Plex test The highest sample had a value of 82 LU The average value was 3 4 LU The SD was 6 8 The cutoff is 2 4 SD above One hundred sixty samples from normal blood donors were run on the QUANTA Plex ENA Profile 5 test One All one hundred sixty of the normal samples were negative on the Sm portion of the QUANTA Plex test The hundred fifty eight normal samples were negative on the SS A 52 portion of the QUANTA Plex test The highest gt Werfen Group sample had a value of 49 LU The average value was 3 8 LU with a standard deviation SD of 4 9 The cutoff is 3 3 One hundred fifty nine of the normal samples were negative on the SS A 60 portion of the QUANTA Plex test The highest sample had a value of 31 LU The average value was 2 5 LU with a SD of 2 8 The cutoff is 6 3 SD above the average the average average value was 2 6 LU with a SD of 2 4 The cutoff is 7 2 SD above the average 4 highest sample had a value of 48 LU The average value was 5 5 LU with a SD of 4 7 The
10. g Calibrator An anti lgG coated control bead is included in each microwell to ensure that false negative each microwell A second incubation allows the anti human IgG fluorescent conjugate to bind to any patient autoantibodies that have become attached to the antigen on the beads The samples are then measured in the results due to operational errors are detected Antinuclear autoantibodies ANA are found in a wide variety of connective tissue diseases Testing for ANA on HEp 2 cells or an ANA ELISA serves as a sensitive screening assay 1 While ANA testing is san excellent screening test for systemic lupus erythematosus SLE a negative result virtually rules out active SLE Follow up testing is typically done on sera that yield positive ANA results Six of the more common autoantibodies react specifically with Sm RNP SS A 52 SS A 60 SS B and Scl 70 extractable nuclear antigens Autoantibodies to these ENAs can contribute significant diagnostic and prognostic information when evaluating patients suspected of a variety of connective tissue diseases such as SLE Sjd gren s syndrome test ENAs A variety of methods including ELISA Ouchterlony double diffusion Western blot and passive agglutination have Scleroderma Mixed Connective Tissue Disease and Polymyositis been used to detect antibodies to Sm RNP SS A 52 SS A 60 SS B and Scl 70 The fluorescent immunoassay FIA technique employed by the QUANTA Plex ENA Profi
11. immunoassay for detection of autoantibodies to nuclear antigens Clin Diagn Lab Immunol 11 1054 1059 Tuomi T Which antigen to use in the detection of rheumatoid factors Comparison of patients with 2009 APR 7 2004 Biosafety in Microbiological and Biomedical Laboratories Centers for Disease Control and Prevention National Institutes of Health Fifth Edition 2007 rheumatoid arthritis and subjects with false positive rheumatoid factor reactions Clin Exp Immunol 17 77 349 1989 Health 2007 Fifth Edition 18 INOVA Diagnostics Inc 9900 Old Grove Road San Diego CA 92131 NCCLS 708920 Page 8 of 8
12. ity in LU of a given sample for each type of antigen can then be calculated by the following formula Divide the MFI of the sample by the The following example is for determining anti Sm reactivity Use the equivalent formula for each of the other antigens Calculations Calculation of Results Sample MFI for Sm Sm Calibrator MFI LU lt 20 MFI of the ENA Profile 5 Calibrator for that antigen and multiply the result by the number of LU assigned to the ENA 20 49 Profile 5 Calibrator for that antigen The LU of the Calibrator for each antigen is found on the box label for that kit lot x Sm Calibrator value in LU Sample Value in LU The sample can then be classified according to the table below Negative Weak Positive Moderate Positive 50 100 Strong Positive gt 100 Reactivity is related to the quantity of autoantibody present on the bead in a non linear fashion While increases and decreases in patient antibody concentrations will be reflected in a corresponding rise or fall in fluorescent reactivity the change is not proportional i e a doubling of the antibody concentration will not double the reactivity In addition the amount of total IgG in a patient s serum affects the measured MFI If a more accurate quantitation of patient autoantibody is required the sample should be run on a quantitative test The ability of the QUANTA Plex ENA Profile 5 test to detect Sm RNP SS A 52 SS A 60 SS B and Scl 70 antibodies was evaluat
13. ld be re tested to confirm the negative result The QUANTA Plex Negative Control and the ENA Profile 5 Calibrator and Positive Control are intended to monitor for substantial reagent failure The user should refer to CLSI formerly NCCLS Document C24 A3 for additional guidance on appropriate QC practices If desired a well with HRP Sample Diluent but no serum can be run to confirm that the anti lgG control bead will detect a well with no serum This serum free control should be lt 3 0 LU on the anti lgG control bead Page 3 of 8 6 and negative on all other beads Using the Luminex Flow Analyzer 1 See the user s manual provided with the Luminex for detailed instructions on running the Luminex flow analyzer and the Luminex Integrated System IS Version or the Version 2 0 or higher software program The data for the ENA Profile 5 were collected using IS Version 1 7 and 2 2 329 For additional information and for troubleshooting problems with this assay contact INOVA Diagnostics Inc technical service at the address or telephone number found on the last page of the Direction Insert Brief Luminex flow analyzer operating instructions are provided below Calibrate the Luminex using the Calibration and Control beads supplied by Luminex Corporation at least once per month and verify that calibration was successful In addition calibrate the Luminex if the delta NCCLS 708920 calibration temperature is more than 3 degrees if
14. le 5 is objective semi quantitative and can be conveniently used to simultaneously test large numbers of patients on each of these 6 ENAs Semi quantitative results are obtained for each autoantibody reactivity The QUANTA Plex ENA Profile 5 is a fluorescent immunoassay for the semi quantitative detection of Sm RNP and the related connective tissue diseases Sjogren s Syndrome and Scleroderma Polystyrene microwell plate 12 1 x 8 microwell strips with holder containing beads of 7 different colors Each of the colored beads is coated with a different purified antigen Sm RNP SS A 52 SS A 60 SS B SS A SS B and Scl 70 autoantibodies in human serum The presence of these antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of systemic lupus erythematosus NCCLS 708920 Page 1 of 8 Reagents 1 Scl 70 and an anti IgG control in a foil package containing desiccants QUANTA Plex Negative Control 1 vial of buffer containing preservative and human serum with no human IgG antibodies to antigens in the ENA Profile 5 prediluted 1 2mL ENA Profile 5 Calibrator 1 vial of buffer containing preservative and human serum antibodies to Sm RNP SS A 52 SS A 60 SS B and Scl 70 antigens prediluted 1 2mL 3 A Diagnostics Inc INOVA 9900 Old Grove Road San Diego CA 92131 1638 USA Tel 1 858 586 9900 Fax 1 858 586 9911 http Awww inovadx com ENA Profile 5
15. must be used when manually adding samples and mixing the beads Use one of the timing sequences for adding the controls as described in step 3 Vigorously pipet at least 30uL of the QUANTA Plex Negative Control and ENA Profile 5 Calibrator NCCLS 708920 Page 4 of 8 front to back assay variation and Positive Control up and down four times in order to mix the beads and the controls in each microwell The 30 minute incubation time begins after adding the QUANTA Plex Negative Control into the first microwell Immediately continue the assay by adding 5uL of diluted patient serum to the appropriate microwells note this makes a 1 1010 final dilution of the patient serum Maintain the same timing sequence as used in step 4 Mix the diluted patient sample and the HRP Sample Diluent in the microwell by vigorously pipetting at least 30uL of the contents of the microwell up and down four times Continue timing the incubation for 30 minutes from the time of the addition of the QUANTA Plex Negative Control Place the microwell strips at room temperature on a level surface and away from direct sunlight for the remainder of At the end of the first incubation period add 50uL of the fluorescent Conjugate to each microwell and vigorously pipet at least 60uL of the contents of the microwell up and down four times Maintain the same timing sequence for adding the conjugate that was used in steps 4 and 5 The conjugate should be removed from the
16. nalyzer ensure that it is warmed up and perform all daily maintenance successful Bring all reagents and patient samples to room temperature 20 26 C and mix them well If the anti human IgG fluorescent conjugate has not been reconstituted add 6mL of QUANTA Plex Conjugate Diluent to the amber vial containing the lyophilized powder and swirl the container for 4 Make sure that the sheath fluid container in the Luminex is filled with Sheath Fluid available from Luminex Corporation 5 Prepare a 1 101 dilution of each patient sample by adding 5uL of each serum to 500uL of HRP Sample Diluent then vortex to thoroughly mix the solution Diluted samples must be used within 8 hours of months at 2 8 C Do not freeze preparation DO NOT DILUTE the QUANTA Plex Negative Control and ENA Profile 5 Low and High Determination of the presence or absence of Sm RNP SS A 52 SS A 60 SS B and Scl 70 antibodies using arbitrary units requires one microwell each for the Negative and Positive Controls two microwells for the Calibrator and one microwell for each patient sample It is recommended that samples be run in Positives 7 singleton All reagents must be brought to room temperature 20 26 C prior to beginning the assay Place the required number of microwells strips in the holder Immediately return unused strips to the pouch Assay Procedure containing desiccants and seal securely to minimize exposure to water vapor and light mi
17. number of samples were assayed 8 times each on a single assay The variation in two different samples for each test specificity is listed in the table below Inter assay variation Intra assay variation Antigen Average LU C V Antigen AverageLU CV SS A 52 32 17 SS A 52 33 14 SS A 52 173 19 SS A 52 163 4 SS A 60 26 8 SS A 60 26 13 SS A 60 203 5 SS A 60 202 2 SS B 27 12 SS B 28 11 SS B 266 10 SS B 275 1 Sm 29 8 Sm 28 8 Sm 209 12 Sm 216 6 RNP 39 4 RNP 40 8 RNP 144 9 RNP 156 4 Scl 70 26 11 Scl 70 26 11 Scl 70 202 9 Scl 70 199 5 Limitations of the Procedure The presence of immune complexes or other immunoglobulin aggregates in the patient sample may cause an increased level of non specific binding and produce false positives in this assay Not all SLE Sj gren s syndrome or scleroderma patients are positive for Sm RNP SS A 52 SS A 60 SS Results of this assay should be used in conjunction with clinical findings and other serological tests Failure to adequately mix the controls and or the diluted serum samples with the preserved beads in the plate may yield higher C V values than those typically found in ELISA assays After the half hour incubation with the fluorescent conjugate there is approximately a 10 further increase 4 in fluorescence for every additional half hour of incubation time von Muhlen CA and Tan E Autoantibodies in the Diagnosis of Systemic Rheumatic Diseases Seminars in NCCLS 708920
18. ons Additional controls may be tested according to guidelines or requirements of local state and or federal regulations or accrediting organizations Additional suitable control sera may be prepared by aliquoting 1 2 3 Note that since the ENA Profile 5 Calibrator and Positive Control and QUANTA Plex Negative Control are pooled human serum specimens and storing them at lt 20 C In order for the test results to be considered valid all of the criteria listed below must be met If any of these The value of the QUANTA Plex Negative Control must be lt 20 LU on each of the 6 antigens are not met the test should be considered invalid and the assay repeated The value in Luminex Units LU of the Calibrator for each antigen is found on the box label for that kit Refer to the formula in the Calculation of Results section to determine the LUs of the QUANTA Plex Negative Control and the Positive Control and between 10 and 50 LU on the anti IgG bead The value of the ENA Profile 5 High Positive must be gt 100 LU and lt 300 LU on each of the 6 a b The anti IgG control bead is meant to ensure that false negative patient results due to operational errors are detected The possibility exists that patient sample and or conjugate was not added to antigens and between 10 and 50 LU on the anti IgG bead C the patient sample well if the patient sample s anti lgG bead is less than 3 LU In this case the patient shou
19. ter diluter 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 lipemic serum should be avoided Following collection the serum should be separated from the clot CLSI formerly NCCLS 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 hrs or for shipment of the sample freeze at 20 C or lower Frozen specimens must be Specimen Specimen Collection Store all the kit reagents at 2 8 C Do not freeze Reagents are stable until the expiration date when stored mixed well after thawing and prior to testing Special Safety Precautions Storage Conditions j and handled as directed i desiccants and stored at 2 8 C 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 Unused microwell strips with antigen coated beads should be securely resealed in the foil pouch containing Procedural Notes Warnings WARNING The HRP Sample Diluent and controls contain a chemical 0 02 chloramphenicol known to the State of California to cause cancer Sodium Azide is
20. the assay controls are out of range or as needed 4 The Luminex takes 30 minutes to warm up after being turned on When the warm up period is completed perform the prime alcohol flush and wash operations recommended by the manufacturer If using IS Version 2 0 software or higher load the ENA Profile 5 template and ensure that all lot information is correct If necessary update the lot information If using Version 1 7 software set the parameters as follows The bead colors are SS A 52 19 SS A 60 17 SS B 7 Sm 8 RNP 9 Scl 70 11 anti lgG 42 Set the events per bead to 50 the sample size to SOUL the flow rate to 60uL minute fast and the gate at approximately 7500 to 17000 The median values are used for the Median Run the Luminex by clicking the Start Plate operations as previously described If necessary calibrate the instrument and verify that the calibration was 5 Input the sample names either manually or by clicking on Load Pa List 6 7 8 When finished for the day perform the sanitize and soak operations prior to turning the instrument off ethod Before you start approximately 30 seconds to dissolve the contents The reconstituted fluorescent conjugate is stable for 3 Fluorescent Intensity MFI Load the plate into the XY platform of the Luminex M 1 For programming information for automated equipment contact INOVA Diagnostics Technical Services 2 Turn on the Luminex flow a
21. 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 1 2 complete assurance that HIV HBV HCV or other infectious agents are absent Therefore the Negative Control and the ENA Profile 5 Calibrator and Positive should be handled in the same manner as potentially infectious material 3 Use appropriate personal protective equipment while working with the reagents provided Spilled reagents should be cleaned up immediately Observe all federal state and local environmental regulations when disposing of wastes Substitution of components other than those provided in this kit may lead to inconsistent results All controls 1 2 3 Adaptation of this assay for use with certain automated liquid sample processors was shown to yield equivalent results to those obtained using the manual procedure It is the responsibility of each laboratory to gt Werfen Group Diagnostics inc Precautions This product is for n Vitro Diagnostic Use are kit lot number specific validate that their automated procedure yields test results within acceptable limits A variety of factors influence the assay performance These include the starting temperature of the reagents the ambient temperatur
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