view pack insert - The Tulip Group, India
Contents
1. Page 8 of 8 Page 1 of 8 7 PRECAUTIONS a Forlaboratory use only b Bring all the reagents to room temperature 20 30 C before use c Donotuse the kits beyond expiry date d Carefully read the User Manual and package insertbefore use e Take UniversalP recautions Treatall reagents and controls as potentially infectious f Always be prepared for any accidental spillage In case of accidental spillage clean the area thoroughly and wipe with 70 IPA atleastthree times g Itis recommended that basic Personal Protective Equipment like gloves and masks are used at all times h UseapotentHandrub before and after test procedure i Visually examine the UTI Control kit and the Buffer Media to ensure there is no physical damage microbial contamination discoloration precipitation evaporation or other signs of deterioration If any of these is observed do notuse these reagents and contact Service provider immediately j The UTI Control vial and the Buffer Media vial with tight caps should be opened carefully to avoid injury due to breakage ofglass k Donotopen the UTI Control vial and the Buffer Media vial until ready to use I Minimize exposure to light 8 CLEANING AND DECONTAMINATION a Spills of potentially infectious material should be cleaned up immediately with absorbenttissue paper and the contaminated area should be decontaminated with disinfectants such as 0 5 freshly prepared sodium hypochlori2. Si lt M CROPRO Broth Culture System UTI Controls 1 INTENDED USE The MICROPRO UTI control kit consists of eight different UTI pathogens each available in a lyophilized format forthe validation of MICROPRO Broth Culture System 2 INTRODUCTION MICROPRO Broth Culture System BCS anovel method for diagnosis of UTI infection detects and enumerates the UTI organisms in less than 4 hours This method uses a proprietary broth culture medium the Barcoded Cuvettes A and the Test Vials B for the growth of the UTI organisms For samples thatare positive significant bacteriuria in the broth culture medium the causative UTI pathogen can be identified biochemically within twenty five minutes using the MICROPRO ID kit The MICROPRO UTI control kit consists of eight different UTI pathogens controls for performing quality control of 1 MICROPRO BCS Broth culture media the Barcoded Cuvettes A and Test Vials B 2 MICROPRO ID reagents 3 Assay procedure ofboth broth culture system and identification system 4 MICROPRO BCS Analyzer 3 TESTPRINCIPLE The properties of the UTI lyophilized control reagents when reconstituted with an appropriate buffer media are similar to the UTI positive specimen As these UTI controls have assigned values when Substituted in place of specimen they serve as reagent and procedure quality control for both MICROPRO Broth culture and MICROPRO IDassays 4 KITCONTENTS
3. A with black cap along with the stopper tightly place itback inthe cuvette stand 10 Retrieve the Test vial B green cap of the same UTI Control open the green cap and rubber stopper placing them on a clean surface 11 Using the 300 ul Fixed Volume Pipette dispense 300 ul of the growth from the Test Vial B in to the next3 wells ofthe same ID well strip 12 Recap the Test Vial B with its green cap along with the stopper tightly place it back in the cuvette stand 13 Repeatthe steps 8 13 for restof the UTI Control Barcoded C uvette A and the Test vial B sets 14 Startthe timer R ead the results after 25 minutes c ResultInterpretation Check the results ofthe UTI Controls as shown below Result Interpretation of wells UTI w1 w4 we Positive results Controls Catalase dee i Mai p Oxidase Da t Indole in wells Test es es Test es Test E coli Bubbles Salmon color Pink ring 1 amp 6 Light Dark pemaes f oak chery in re Streptococcus a pyogenes be Light Proteus Dark mirabi Bubbles Salmon color Boan 1 amp 5 Light pink Proteus spp Bubbles Salmon color gt Dark ring 1 5 amp 6 Brown Pseudomonas 7 Blue to aeruginosa Bubbles Salmon color Purple 1 amp 4 Dark Citrobacter spp Bubbles cherry z 1 amp 3 red Light Klebsiell eee Bubbles Dark Salmon color z F 1 amp 2 Note represents no change Salmon color represents negative result 13
4. The MICROPRO UTI control kit CatNo MSQC01 consists ofthe following S No Component Purpose Qty 1 MICROPRO UTI Controls Eight different UTI Controls lyophilized for 8 Nos red cap 0 5 ml Quality Control ae wl diite TOT 2 PS 2 Buffer Media 5 ml Media for reconstitution of lyophilized UTI Controls 2 Nos i Production Site Consul are Sterile microtips for dispensing Buffer Media in UTI REF abe Tay netos E ey EC REP 3 1 mI Microtips Controle 10 Nos for use Authorised Representative H e 5 STORAGE AND STABILITY Microxpress Store the UTI Controls and the Buffer Media at 2 8 2C A Division of DO NOT FREEZE Avoid exposure to light T TULIP DIAGNOSTICS P LTD The shelf life of the UTI Control kitand the Buffer Media is as per the expiry date mentioned on respective ull PS carton bottle packaging Registered Office Manufacturing Unit Gitanjali Tulip Block Dr Antonio Do Rego Bagh Alto PlotNo S 126 Phase lll B Verna Ind 6 MATERIAL REQUIRED BUT NOT PROVIDED WITH THE KIT ee anaaga mila ee nee 1 ml pipette 100 uI micropipette 300 u I micropipette Soybean Casein DigestAgar or Mueller Hinton Agar EC REP Plates Bacteriological Incubator set at 35 379C Marker Pen Tissue Paper 70 IPA Bactericidal Qarad b v b a Cipalstraat 3 B 2440 Geel Belgium Handrub Gloves and Mask
5. REFERENCES 1 2 3 4 5 Practical Medical Microbiology Mackie and MacCartney Vol 2 13 th ed Churchill Livingston 1989 Edited by G Collee Duguid A G Fraser B P Marmion Detection Prevention and Managementof Urinary Tractinfections C M Kunin 4th E dition 1987 McPherson RA Ben Ezra Basic examination of urine In McPherson RA Pincus MR eds Henry s Clinical Diagnosis and Management by Laboratory Methods 22nd ed Philadelphia PA Elsevier Saunders 2011 chap 28 Hooton TM Bradley SF Cardenas DD et al Diagnosis prevention and treatment of catheter associated urinary tract infection in adults 2009 International Clinical Practice Guidelines from the Infectious Diseases Society of America Clin Infect Dis 2010 50 5 625 663 Ban KM Easter J S Selected urologic problems In Marx J A Hockberger RS Walls RM etal eds Rosen s Emergency Medicine Concepts and Clinical Practice 7th ed Philadelphia Pa Mosby Elsevier 2009 chap 97 Page 4 of 8 Page 5 of 8
6. he UTI control vials 7 Place the reconstituted UTI Controls kit along with the stand in bacteriological Incubator set at35 37 C for16 hours D b Inoculation ofthe UTI Controls into the Barcoded C uvette A and the Test Vial B 1 After 16 hours of incubation retrieve and place the eight reconstituted UTI Controls to be tested on flatclean table top Page 2 of 8 Page 7 of 8 6 DeanA Lee DC Bedside laboratory and microbiologic procedures In Roberts J R Hedges J R eds 2 Retrieve eight sets of Barcoded Cuvettes A black cap and the Test Vials B green cap Clinical Procedures in Emergency Medicine 5th ed Philadelphia P a Saunders Elsevier 2009 chap as one Set of Barcoded Cuvette A black cap and Test Vial B green cap is to be used for 68 one reconstituted UTI control 7 acFaddin J ean F Biochemical Tests for Identification of Medical Bacteria Williams amp Wilkins 3 Labeleach of the Barcoded C uvette A black cap and the Test Vial B green cap set with 1980 pp 173 183 UTI controlname 8 Bachoon Dave S and Wendy A Dustman Microbiology Laboratory Manual Ed Michael Stranz 4 Retrieve 8 pouches of 100 ul micropipette tips The individual microtip pouches must be ason OH Cengage Learning 2008 Exercise 15 Normal F lora ofthe Intestinal Tract P rint opened just before the inoculation process so as to minimize contamination risk 9 Bergey s Manual of Systematic Bacteriology Vo
7. l 1 Baltimore Williams and Wilkins 1984 5 Open the black cap of one of the Barcoded Cuvette A and the green cap of its 10 Nicola F1 Centorbi H Bantar C Smayevsky Bianchini H Utility of pyrrolidonyl arylamidase corresponding Test Vial B and keep aside Do not remove the yellow coloured rubber detection for typing Enterobacteriaceae and non fermenting Gram negative bacteria Rev Argent stopper icrobiol 1995 Oct Dec 27 4 204 9 6 Remove the cap and rubber stopper of the respective UTI Control vial pipette out 100 ul of 11 Gordon J McLeod J W Practical application of the direct oxidase reaction in bacteriology Pathol the well mixed reconstituted UTI Control and transfer it into the opened Barcoded Cuvette Bacteriol 1928 31 185 90 A by piercing the microtip through the rubber stopper 12 Koneman EW Allen SD J anda WM Schreckenberger PC Winn WC J r Color atlas amp textbook of 7 While removing out the microtip from the Cuvette hold the rubber stopper tight so that the diagnostic microbiology 5th ed Philadelphia J B Lippincott 1997 rubber stopper does not come outalong with the microtip Discard the microtip Ensure that 13 L Essers and K Radebold Rapid and reliable identification of Staphylococcus aureus by a latex the UTI Control mixes well with the broth by gently swirling the vial agglutination test J Clin Microbiol Nov 1980 12 5 641 643 8 Using another fresh microtip pipette out the remaining 100 ul of reconsti
8. tAddition 1 Place the eight 6 wells strips in the MICROPRO ID Well stand ina row 2 Paste a Removable Sticker atthe end of the each well strip row in the well stand to write the UTI Control name 3 Retrieve the eight MICROPRO ID reagents and place iton the table Allow itto attain room temperature 4 AsshowninTable 3 to the Firstwellstrip Dispense 2 drops ofR 1 reagentinto first well 2 drops ofReagentR 2 1 R 2 2 amp R 2 3 each to wellNo 2 2 drops of ReagentR 3 to well No 3 2 drops of ReagentR 4 to well No 4 2 drops ofReagentR 5 to wellNo 5 2 drops of ReagentR 6 to wellno 6 The corresponding well numberis also mentioned on each ID reagentbottle labels Table 3 Well Nos R2 2 1 MICROPRO ID R1 R2 2 2 R3 R eagents Er 2 drops Reagent Volume 2drops 2drops 2 drops 2 drops 5 Continue Step No 4 forthe nextseven well strip rows b SampleAddition 6 Fromthe Cuvette stand retrieve one set of Barcoded C uvette A incubated with UTI control and its corresponding Test Vial B Check the UTI control name on the Barcoded Cuvette A and note itdown on the removable sticker of the firstrow ofthe well strip 7 Remove the black cap and the rubber stopper of the Barcoded Cuvette A and place iton a clean surface 8 Using a 300 ul Fixed Volume Pipette dispense 300 ul of the growth from Barcoded Cuvette A into the first 3 wells ofthe first ID well strip 9 Recap the Barcoded Cuvette
9. te 10 times dilution of 5 sodium hypochlorite household bleach before continuing work b Sodium hypochlorite should not be used on an acid containing spill unless the spill area is wiped dry first Materials used to clean spills including gloves should be disposed off as potentially biohazardous waste e g in a biohazard waste container 9 TESTPROCEDURE A Quality Control of MICROPRO Broth Culture System a Reconstitution of UTI Controls Note The UTI Controls kit consists of eight different UTI controls pathogens available in lyophilized form Forreconstitution of UTI controls maintain a sterile environment while working in LaminarAir flow orin between two Bunsen burners 1 Open the red cap and rubber stopper of one UTI control vial and place them on a sterile area 2 Using 1 ml pipette and a sterile microtip provided with the kit reconstitute the UTI control with 1 ml Buffer Media and then pipette in and outseveral times to ensure proper dispensing and mixing of lyophilized cultures in the Buffer Media 3 After reconstitution using the same tip perform streaking on Soybean Casein DigestAgar orMuellerHintonAgarP lates to check for contamination 4 Discard the tip in 0 5 freshly prepared sodium hypochlorite solution and put the rubber stopperand red cap back on the UTI control vial 5 Gently swirl the vial to ensure proper mixing of lyophilized cultures in the broth Using a fresh tip repeatsteps 1 to 5 forrest of t
10. tuted UTI control 14 Kloos W E and P B Smith Staphylococci 1980 Manual of Clinical Microbiology 3rd ed E H from the same UTI Control vial and transfer it to the corresponding opened Test Vial B by Lennette A Balows W J Hausler J r and J P Truant ed ASM Washington D C piercing the micropipette tip through the stopper of the Test Vial Again ensure that the UTI 15 Finegold S M and E E Sweeney 1961 New Selective and Differential Medium for Coagulase Control mixes well with broth in theTest Vial B by gently swirling the vial Positive S taphylococciAllowing Rapid Growth and Stain Differentiation J Bacteriol 81 636 641 9 Repeat step 5 8 for the rest of the reconstituted UTI controls Use fresh microtips each 16 Data on file Microxpress P Ltd time 10 The Barcoded Cuvettes A and the Test Vials B can then be recapped with their original black and green cap respectively and placed in the Cuvette stand card board fitment Supplied with the kit Note Forthe rest of the procedure namely c Blanking ofthe MICROPRO BCS Analyzer d Measuring Initial Absorbance A0 e Incubation of the inoculated Barcoded Cuvettes A and the TestVials B f FinalAbsorbance A1 of the Barcoded Cuvettes A Follow the procedure from the MICROPRO Broth Culture System pack insert refer Segment 10 TEST PROCEDURE Section B C D amp E g Resultinterpretation of Barcoded C
11. uvettes A black cap inoculated with UTI controls The difference in the final A1 and initial AQ OD readings of the UTI controls i e Delta OD Values obtained in the Results of the MICROPRO BCS Analyzer for each of the Barcoded Cuvettes A with different UTI Controls should match with the Expected Delta OD Values given in the following table Table 1 forthe eight different UT Controls Table 1 UTI Controls Expected Values UTIControls Expected Values CFU ml CFU ml E coli 10 3 lt 10 8 CFU ml Proteus spp 10 3 lt 10 8 CFU ml Enterococcus faecalis 10 3 lt 10 8 CFU ml Pseudomonas aeruginosa 10 3 lt 10 8 CFU ml Streptococcus pyogenes 10 3 lt 10 8 CFU ml Citrobacter spp 10 3 lt 10 8 CFU ml Proteus mirabilis 10 3 lt 10 8 CFU ml Klebsiella pneumoniae 10 3 lt 10 8 CFU ml Page 6 of 8 Page 3 of 8 B Quality ControlofMICROPRO ID System Note A MICROPRO ID well strip consists of twelve breakable wells Six wells are required to perform the six tests for identifying a single UTI Control refer Table 2 Table 2 Well Nos and Tests wi w2 W3 wa w5 w6 Catalase Voges Proskauer Pyrrolidonyl Arylamidase Oxidase Tryptophan deaminase Indole test VP test PYR test test TDA Test test For identifying eight UTI Controls use four MICROPRO ID well strips and break each strip equally into two to geteightof 6 well strips a Reagen
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