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1. i lt M CROPRO Broth Culture System For the Detection Enumeration and Identification of UTI Pathogens 1 INTENDEDUSE MICROPRO BCS Broth Culture System is a complete system that detects enumerates and identifies most pathogens involved in Urinary tract infections in less than five hours It consists of 1 Broth Culture System that uses a Turbidimetry based analyzer for the detection and enumeration of UTI pathogens 2 ID System for Biochemical identification of the UTI organisms 2 INTRODUCTION Urinary tract infection or UTI is a major cause of morbidity in humans and one of the most frequently encountered infections thatneeds to be detected and diagnosed atthe very earliest These infections can occur at different points in the urinary tract including bladder where it is called cystitis in the urethra urethritis and in severe cases when infection moves upwards and affects the kidneys where itis known as pyelonephritis Symptoms of a lower urinary tract infection can include painful urination and either frequent urination or urge to urinate or both while the symptoms of pyelonephritis include fever and flank pain in addition to the symptoms of a lower UTI About 40 of women and 12 of men have a urinary tractinfection atsome time in their life The main causative agent of most UTI s is Escherichia coli though other bacteria viruses or fungi may rarely be the cause Most of the UTI are caused by the eight common urina2. Broth Medium Broth Medium LZV30 Linezolid LZ 30 mcg 5 Vials J LZ001 Single Via MRPT10 5 Carts lt Step 2 Measure Initial OD A0 MRPV10 Meropenem MRP 10mcg 5 Vials of Barcoded Cuvette A MRPOO1 Single via After Initial OD AQ ce Mediocii Wz es api P Step 3 Incubate Barcoded Cuvette A amp Test Vial B for four hours lezlocillin mcg als MZ001 Single via INCUBATOR 35 37 C MXFT5 5 Carts l a MXFV5 Moxifloxacin MXF 5 mcg 5 Vials b 4 Single via dae 9 Step 4 After incubation gently swirl NITT300 5 Carts the Barcoded Cuvette A to NITV300 Nitrofurantoin NIT 300 mcg 5 Vials homogenize the contents NIT0001 Single via Measure Final OD A1 of the Barcoded Cuvette A NXT10 5 Carts NXV10 Norfloxacin NX 10 mcg 5 Vials After Final OD A1 NX001 Single via gt Step 5 If POSITIVE results in Barcoded Cuvette A OXT1 5 Carts Proceed for ID testing of Barcoded Cuvette A amp Test Vial B OXV1 Oxacillin OX 1mcg 5 Vials 0X01 Single via 4 4 PIT100 5 Carts MICROPRO ID TEST PIV100 Piperacillin PI 100 mcg 5 Vials c is sn 000 000 PTZT100 5 Carts Catalase Test VP Test PYR Test f Oxidase Test TDA Test Indole Test PTZV100 Piperacillin Tazobactam PTZ 100 10 mcg 5 Vials PTZ0001 Single via TEIT30 5 Carts TEIV30 Teicoplanin TEI 30 mcg 5 Vials 6 STORAGE AND STABILITY TE1001 Single via a S tore the Barcoded Cuvettes A black cap Test Vials B green cap and the ID reagents at 2 8 C b TET30 5 Carts
3. 22 In the display menu of the Analyzer using the scroll down Arrow key bring the display cursor to FinalAbsorbance in the Main Menu and press NEXT 23 Retrieve one incubated Barcoded Cuvette A before inserting it in Analyzer for measuring Final absorbance kindly note itis imperative to gently swirl the Barcoded Cuvette A to disperse Page 8 of 12 Page 5 of 12 culture in the broth Do not shake the cuvette vigorously as this may result in false negative results Check Section15 Remarks After mixing the contents follow the procedure as in step 11 24 On valid identification of the Barcoded Cuvette A the Analyzer will display the patient name sample ID test ID and Final absorbance Press NEXT key as this will ensure recording of the Final absorbance A1 value in the memory of the Analyzer Remove the Barcoded Cuvette A from the reading chamber and place itin the Cuvette stand 25 Repeatsteps 23 24 forrestofthe incubated Barcoded Cuvettes A 26 After completing the Final absorbance A1 for all the incubated Barcoded Cuvettes A scroll down in main menu to bring the display cursor to Results and press NEXT The results will be displayed Sample Id Wise and the print out can be taken Details of the Result menu managementis mentioned in the MICROPRO BCS Analyzer user manual F Resultinterpretation of Barcoded Cuvettes A black cap There are five types of res
4. 5 Ban KM Easter J S Selected urologic problems In Marx JA Hockberger RS Walls RM etal eds Rosen s Emergency Medicine Concepts and Clinical Practice 7th ed Philadelphia Pa Mosby Elsevier 2009 chap 97 6 Dean AJ Lee DC Bedside laboratory and microbiologic procedures In Roberts J R Hedges J R eds Clinical Procedures in Emergency Medicine 5th ed Philadelphia Pa Saunders Elsevier 2009 chap 68 7 MacF addin J ean F Biochemical Tests for Identification of Medical Bacteria Williams amp Wilkins 1980 pp 173 183 8 Bachoon Dave S and Wendy A Dustman Microbiology Laboratory Manual Ed Michael Stranz Mason OH Cengage Learning 2008 Exercise 15 Normal Flora of the Intestinal Tract Print 9 Bergey s Manual of Systematic Bacteriology Vol 1 Baltimore Williams and Wilkins 1984 10 Nicola F1 Centorbi H Bantar C Smayevsky J Bianchini H Utility of pyrrolidonyl arylamidase detection for typing Enterobacteriaceae and non fermenting Gram negative bacteria Rev Argent Microbiol 1995 Oct Dec 27 4 204 9 11 Gordon McLeod J W Practical application of the direct oxidase reaction in bacteriology J Pathol Bacteriol 1928 31 185 90 12 Koneman EW Allen SD J anda WM Schreckenberger PC Winn WC Jr Color atlas amp textbook of diagnostic microbiology 5th ed Philadelphia JB Lippincott 1997 13 L Essers and K Radebold Rapid and reliable identification of Staphylococcus aureus by a latex agglu
5. DO NOT FREEZE Avoid exposure to light c The shelf life of the Barcoded Cuvettes A black cap Test TEV30 Tetracycline TE 30 mcg 5 Vials Vials B green cap and the ID reagents is as per expiry date mentioned on respective carton bottle TE001 Single via packaging TGCT15 5 Carts TGCV15 Tigecycline TGC 15 mcg Vials i 7 MATERIAL REQUIRED BUT NOT PROVIDED WITH THE KIT on z Bacteriological Incubator at 35 37 C Marker Pens Timer Tissue Paper 70 IPA Bactericidal Handrub a loves Masks and Removable Stickers TOBV10 Tobramycin TOB 10 mcg 5 Vials Sipes Maskan SmoVa aleg thet TOB001 Single vial Page 10 of 12 Page 3 of 12 8 PRECAUTIONS 16 BIOGRAM Antibiotics Disc as perCLSI standards a For laboratory use only b Bring all reagents and specimen to room temperature 20 30 C before use c Do not use the kits beyond expiry date d Carefully read the User Manual and package inserts before use e Take Universal Precautions All human body fluids should be treated as potentially CAT NO ANTIMICROBIAL AGENT SYMBOL DISC CONTENT PACK SIZE infectious f Always be prepared for any accidental spillage In case of accidental spillage clean the area _ __ _ _ pTp thoroughly and wipe with 70 IPA atleastthree times g Itis recommended thatbasic Personal Protective poe ikaci a carts Jk AKV30 Amikacin AK 30 mcg 5 Vials Equipmentlike gloves
6. Representative Apart from this a separate MICROPRO ID kit is available for the biochemical identification of UTI pathogens The Biochemical analysis of UTI organisms can be completed in less than twenty five Microxpress minutes ee 3 SPECIMEN COLLECTIONAND PREPARATION T TULIP DIAGNOSTICS P LTD a First morning voided midstream and clean catch urine is recommended for testing Urine from first f l wil LPs morning catheterization or suprapubic taps can also be used Follow standard recommended procedures Registered Office Manufacturing Unit i i i x i i Gitanjali Tulip Block Dr Antonio Do Rego Bagh Alto PlotNo S 126 Phase IlI B Verna Ind for collection of urine specimen b Fresh urine should be used for testing If a delay in testing is ne PO G0a 403202 india Estate Vema Goa 403722 INDIA anticipated store the specimen immediately at 2 82C and ensure that the testis performed within 3 hours EC REP c It is recommended that sterile containers are used to collect specimen Contamination of specimen Qarad b v b a Cipalstraat 3 B 2440 Geel Belgium mustbe avoided Page 12 of 12 Page 1 of 12 CAT NO ANTIMICROBIAL AGENT SYMBOL DISC CONTENT PACK SIZE TRT5 5 Carts TRV5 Trimethoprim TR 5 mcg 5 Vials TRO1 Single vial COTT25 5 Carts Trimethoprim i coTv25 COT 1 25 23 75 mcg 5 Vials c
7. and masks are used atall times h Use a Bactericidal Handrub before and after test AKO01 Single via procedure I Visually examine the Barcoded Cuvettes A with black caps and the Test Vials B with green AMPT10 5 Carts caps to ensure there is no physical damage microbial contamination discoloration precipitation AMPV10 Ampicillin AMP 10 meg 5 Vials evaporation or other signs of deterioration If any of these is observed do no use these reagents and AMPO001 Single via contact Service provider immediately j The Barcoded Cuvettes A and the Test Vials B are capped AMCT30 5 Carts tightly open carefully to avoid injury due to breakage of glass k Minimize exposure to light I E nsure that AMCV30 Amoxicillin Clavulanate AMC 20 10 mcg 5 Vials the broth culture media Barcoded Cuvettes A the Test Vials B attain room temperature before AMC001 Single via inoculation and for Biochemical Identification test ATT30 5 Carts ATV30 Aztreonam AT 30 mcg 5 Vials 9 CLEANING AND DECONTAMINATION ATO01 Single via a Spills of potentially infectious material should be cleaned up immediately with absorbent paper tissue C2730 5 Carts uh Hic o CZV30 Cefazolin CZ 30 mcg 5 Vials and the contaminated area should be decontaminated with disinfectants such as 0 5 freshly prepared Sinole via sodium hypochlorite 10 times dilution of 5 sodium hypochlorite i e household bleach before continuing ce 9 work b Sodium hypochlorite should not be used on an
8. green CACOOL Notas pereks Single Via cap corresponding to the numberof samples to be tested and place iton a stand ora flatclean table CTRT30 5 Carts top Kindly note that a single set of Barcoded Cuvette A black cap and the Test Vial B green aeh F ennaxone om atm rie cap is to be used forone patient eure Tare 2 Write patient IDs names specifically within the space indicated on each set of Barcoded C uvette CXMV30 Cefuroxime CXM 30 mcg 5 Vials A black cap and the Test Vial B green cap CXM001 Single via 3 Retrieve the required number of 100 u I micropipette tip pouches from the pack A pair of microtip is CIPTS 5 Carts to be used for testing one patient sample The Individual microtip pouches must be opened just CIPVS Ciprofloxacin CIP 5 mcg 5 Vials before the inoculation process so as to minimize contamination risk aie Single via 4 Open the black cap of the Barcoded Cuvette A and the green cap of the Test Vial B of one CDv2 Clindamycin cD 2 meg a patientand keep aside Do notremove the yellow coloured rubber stopper CD01 Single via 5 Pipette out 100 pl of well mixed urine from the sample container and transfer it to the opened CLT10 5 Carts Barcoded Cuvette A by piercing the pipette microtip through the stopper of the Cuvette and CLV10 Colistin CL 10 mcg 5 Vials pressing the plunger of micropipette up to the bottom Do not release the plunger Holding the CLO01 Single via rubber stoppertightin its place slowly remove the microtip
9. menu will be displayed using the scroll down Arrow key bring the cursor from Lot number to InitialAbsorbance and press NEXT Measuring Initial Absorbance Ao of inoculated Barcoded C uvette A black cap on the MICROPRO BCS Analyzer 14 Retrieve one Barcoded Cuvette A inoculated with patient s urine sample 15 Insertitcarefully in reading chamber as in Step No 11 16 The initial absorbance Ao for the particular Barcoded Cuvette A will be displayed on the Analyzer screen Press NEXT key as this will ensure recording of the Initial absorbance Ao value in the memory ofthe Analyzer Remove the Barcoded Cuvette A from the reading chamber and place itin the cuvette stand 17 Repeat steps 14 16 for restof the inoculated Barcoded Cuvettes A Do notinsertTest Vial B in the reading chamber 18 Aftermeasuring Ao values of all the Barcoded Cuvettes A do notswitch OFF the Analyzer 19 Proceed for Incubation ofthe Barcoded Cuvettes A and the Test Vials B Incubation of the inoculated Barcoded Cuvette A black cap and the Test Vials B green cap 20 Incubate all the inoculated Barcoded Cuvettes A and the Test Vials B for 4 hours in a Bacteriological Incubator at35 37 C 21 After 4 Hrs of incubation proceed to measure the Final absorbance A1 values of the Barcoded Cuvettes A on the MICROPRO BCS Analyzer Measuring FinalAbsorbance A1 of the incubated Barcoded Cuvettes A black cap
10. ON OF UTI PATHOGENS The MICROPRO ID test helps in identifying the eight possible UTI pathogens namely E coli Enterococcus faecalis Streptococcus pyogenes Proteus mirabilis Proteus spp Pseudomonas aeruginosa Citrobacter spp Klebsiella pneumoniae For the Test procedure refer the MICROPRO ID kitPack insert 12 ANTIBIOTIC SUSCEPTIBILITY TEST After the completion of Biochemical Identification tests proceed for Antibiotic Susceptibility Test in four Steps as follows Step 1 After completing Biochemical Identification tests about 1 ml of broth will remain in MICROPRO Barcoded Cuvette A Centrifuge the cuvettes at RCF of 5000 g for 10 minutes at room temp A visible pellet will be observed Discard the supernatant carefully by inverting the cuvette and retain the pellet With a sterile loop touch the pellet and transfer it to the tube of saline peptone water Dissolve the inoculum thoroughly to avoid clumping of the cells Adjust turbidity of inoculum to match the standard i e McFarland 0 5 equals approximately 10 8 CF U mL Step 2 Proceed for inoculation on Mueller Hinton Agar plate Visually examine the Mueller Hinton Agar plates prior to use ensure that the plates are free from visible contamination poured to a uniform depth of approximately 4mm not excessively wet and not cracked or dry Sterile Ready Prepared Mueller Hinton Agar Plates Cat no P0012011 is available with MICROXPRESS Within 15 minutes of preparing
11. ach batch to ensure that 1 Barcoded C uvettes A Test Vials B the MICROPRO ID Kit reagents and the MICROPRO BCS Analyzer are working as per specifications For the Testprocedure refer the MICROPRO UTI Control Kitpack insert Page 6 of 12 Page 7 of 12
12. acid containing spill unless the spill area is wiped CPMT30 5 Carts fica CPMV30 Cefepime CPM 30 mcg 5 Vials dry first Materials used to clean spills including gloves should be disposed off as potentially biohazardous CPMO01 Single via waste e g ina biohazard waste container CTXT30 5 Carts CTXV30 Cefotaxime CTX 30 mcg 5 Vials 10 TESTPROCEDURE CTX001 Single via The user is requested to familiarize with the working of the MICROPRO BCS Analyzer before CECT30 5 Carts embarking on the Test Procedure Kindly referthe MICROPRO BCS Analyzer user manual CECV30 Cefotaxime Clavulanic acid CEC 30 10 meg 5 Vials CEC001 Notas per CLS Single Via 1 Detection and Enumeration of the UTI pathogens CXT30 5 ane The detection and enumeration procedure involves the following steps CXV30 Cefoxitin CX 30 mcg 5 Vials A Inoculation of the Barcoded Cuvettes A black cap and the Test Vials B green cap with the patient s om j j a une specmen PA Ceftazidime CAZ 30 mcg 5 Vials Note a After inoculation only the Barcoded Cuvettes A black cap are to be used for testing on the CAZ001 Single via MICROPRO BCS Analyzer b The Test Vials B green cap along with the Barcoded Cuvettes A CACT30 30 10 mcg 5 Carts black cap are for Biochemical identification ofthe UT organisms using MICROPRO ID kit CACV30 Ceftazidime C lavulanic acid CAC 5 Vials 1 Retrieve the required number of Barcoded Cuvettes A black cap and the Test Vials B
13. d Despite Variation in Initial and Final OD for the same sample inoculated in five cuvettes the result obtained is same owing to the delta OD which diminishes the variation from Cuvette to Cuvette resulting in 100 reproducibility of results B L 15 REMARKS A False negative results can occur if the contents of the Barcoded Cuvette A are not mixed properly prior to measuring the Final absorbance A1 as the culture growth tends to settle down in the Barcoded Cuvette A Test Vial B during incubation To dislodge the cultures settled during incubation the correct way is to Hold the cap of the Barcoded Cuvette A Test Vial B and gently swirl it to form a homogeneous suspension Do not shake vigorously or turn the vial Fig 1 upside down during shaking See Fig 1 Use only the gamma sterile tips provided forthe sample pipette 100 ul Avoid using ETO sterilized tips as there will be ETO residue left on the tip surface which might get added into the broth during inoculation leading to growth inhibition C Procedure for dispensing sample in Broth culture cuvettes A amp B 1 P lace yourthumb overthe top of the pipette plungerand press down to the firststop Hold the plunger in this position 2 Place the pipette tip into the sample at the proper immersion depth and release the pressure on the plunger slowly Be sure that the pipette is either vertical or within 20 off vertical This will allow the piston to rise aspiratin
14. ensuring that the rubber stopper does ETPT10 5 Carts notcome outalong with the microtip Ensure that urine is mixed well with the broth in the Barcoded ETPV10 Ertapenem ETP 10 mcg 5 Vials C uvette A by gently swirling it ETPOOL Single Via Page 4 of 12 Page 9 of 12 14 PERFORMANCE DATA Intemal Evaluation A In an in house evaluation 110 urine specimens were tested simultaneously both on MICROPRO BCS and onstandard solid Agar medium Total Samples 110 MICROPRO BCS PLATE CULTURE Positive for UTI 14 14 Negative for UTI 76 70 Contamination 20 26 From the above evaluation itis observed that ForPositive UTI samples MICROPRO BCS showed 100 correlation with PLATE CULTURE ForNegative samples 76 samples were reported negative by MICROPRO BCS and 70 samples by PLATE CULTURE Contamination was observed in 20 samples tested by MICROPRO BCS and 26 samples by PLATE CULTURE method Precision Stability studies were performed on Broth culture media Barcoded Cuvettes A and Test vials B for color change pH conductivity and OD at 546 nm for three different temperatures 2 8 C Room temperature and 37 C for a period of 15 days and no variation was observed in color and marginal variation was observed in the other parameters Performance Repeatability and Reproducibility were performed with same sample inoculated in five Barcodes Cuvettes A and Initial and Final OD measure
15. g sample fluid into the pipette tip Do not remove your thumb from the plunger abruptly or let the plunger rise up quickly This will result in aspirating incorrect sample volumes 3 Once the plunger reaches the starting position pause fora second ortwo to ensure thatthe aspiration of the sample fluid is complete Be sure there are no bubbles in the tip 4 Remove the pipette tip from the sample volume 5 To dispense pierce the cuvette stopper with the pipette tip and then press the plunger down slow and steadily pass the first stop all the way to the bottom of the piston stroke Wait 1 2 seconds to allow complete dispensing of the sample fluid Do not release the plunger now 6 Remove the pipette tip from the Broth culture cuvette and then release the plunger 7 Press the ejector button to remove the pipette tip or carefully pull the tip off with your fingers and disposed of the tip in the proper biohazard container according to the safety requirements of your facility B B c D Note F or detailed pipetting procedure refer Section 15C 6 Using a fresh microtip pipette out 100 ul of well mixed urine from same sample container and transfer itto the opened Test Vial B by piercing the micropipette tip through the stopper of the Test Vial and pressing the plunger of micropipette up to the bottom Do notrelease the plunger Holding the rubber stopper tight in its place slowly remove the microtip ensuring tha
16. gens Nos MIDR01 Breakable test wells for use in the 12 wells b MICROPRO ID wells Biochemical ID Test x 25 Nos Quality Control kit consisting of a MICROPRO UTI Control Eight different lyophilized UTI Controls 8x1 red cap 0 5 ml Nos 3 Media for reconstitution of the lyophilized MSQC01 b Buffer Media UTI Controls 1 No c 1 mL Micropipette tips Sterile filter barrier microtips for 1 mL 10 Nos Micropipette for the Quality Control test Page 2 of 12 Page 11 of 12 Biogram Pack size 5 Cartridges Each cartridge contains 50 discs amp Vials 5 vials 5 x 100 discs in each vial and single vial 1 x 100 discs in vial Discs in routine use should be stored at 2 8 C Longer term storage should be at 20 C 17 REFERENCES 1 Practical Medical Microbiology Mackie and Edited by J G Collee Duguid A G Fraser B P Marmion 2 Detection Prevention and Management o Urinary Tract infections C M Kunin 4th Edition 1987 3 McPherson RA Ben Ezra Basic examination of urine In McPherson RA Pincus MR eds Henry s Clinical Diagnosis and Management by Laboratory ethods 22nd ed Philadelphia PA Elsevier Saunders 2011 chap 28 4 Hooton TM Bradley SF Cardenas DD etal Diagnosis prevention and treatment of catheter associated urinary tract infection in adults 2009 International Clinical P ractice Guidelines from the Infectious Diseases Society of America Clin Infect Dis 2010 50 5 625 663
17. oTo01 St phamethoxazole Single vial VAT30 5 Carts VAV30 Vancomycin VA 30 mcg 5 Vials VA001 Single vial 4 SYSTEM CONTENTS S No Component Purpose Qty Cat No Installation Pack lpack MSIPO1 1 MICROPRO BCS Analyzer Turbidimetry based analyzer system for Lunit MA0001 one cable cord and two fuses detection and enumeration of UTI pathogens Cuvettes for zero blanking the MICROPRO 2 Blanking Cuvettes 3 ml BCS Analyzer 2 Nos MABCO1 3 Printer Paper Roll Paper Roll for Printing the test results 1No MAPRO1 4 MICROPRO ID Wellstand Stand for ID Test wells 1No MIDSO1 5 Fixed Volume Micropipette Micropipette for dispensing urine specimen 4 No MAFP01 100 uL into Barcoded Cuvette A amp Testing vial B l Fixed Volume Micropipette Micropipette for dispensing the Broth culture 6 300 uL growth into ID Test wells nie wet 7 User Manual 1No Reagent Packs MICROPRO Broth Culture kit Ready to use Barcoded Broth culture a Barcoded Cuvettes A cuvettes for use on MICROPRO BCS black cap 3 ml Analyser amp also for ID Test 25 os b Test Vials B green cap Ready to use Broth culture test vials for ID MBCSO1 1 5 ml test only neat Gamma Sterile microtips with filter barrier 2x25 SUL NICs for use with 100 uL Fixed volume pipette Nos MICROPRO ID kit ee 2 a 8 different ID reagents Reagents for biochemical identification of 8x1 5 ml the UTI patho
18. ry pathogens that account for approximately 97 of infections The primary pathogen involved is Escherichia coli The fairly common secondary pathogens are Enterococcus faecalis Klebsiella pneumoniae Proteus mirabilis Proteus spp Pseudomonas aeruginosa The secondary pathogen which is rarely involved is Citrobacter spp The common urethral or genital florae include the Lactobacillus alpha haemolytic streptococci Gardrerelle vaginalis Corynebacteria spp etc Diagnostic testing of UTI includes urinalysis and urine culture Urinalysis is a Screening test while the urine culture is considered the gold standard and the only way to make conclusive diagnosis of an UTI Antibiotic sensitivity can also be performed with these cultures making them useful in the selection of an appropriate antibiotic for treatment C onventional diagnostic methods include quantitative culture on solid media Gram staining of selected colonies and biochemical identification testing This process can take more than twenty four to forty eight hours before the microorganisms can be reported to the physicians 2 tre at P PS MICROPRO BCS comprises of a novel way to detect and diagnose UTI by the Turbidimetry based a K aae paal verso LOT fier ie Bacterial broth culture detection This system ensures that the entire process of detection and enumeration of UTl organisms is completed in four hours Consult REF r atalogie Li posvactons Use by EC REP Authorised
19. t the rubber stopper does not come outalong with the microtip Ensure that urine is mixed well with the broth in the Test Vial B by gently swirling the urine broth mixture inside the vial 7 Repeatstep 4 6 forall urine samples to be tested Use fresh microtips each time 8 The Barcoded Cuvettes A and the Test Vials B must be recapped with their original black and green cap respectively and placed in the cuvette stand card board fitment supplied with the kit Blanking the MICROPRO BCS Analyzer Blanking is to be done once a day or when the machine gets switched OFF during the procedure 9 Switch ON the MICROPRO BCS Analyzer The red power display LED will blink Press power button followed by the NEXT key The Analyzer will display Insert Blank and press NEXT or EXIT 10 Retrieve one Blanking Cuvette provided with Analyzer Clean the Blanking Cuvette with the dry tissue Note Always make sure to clean the Cuvette with a clean dry tissue paper before blanking ortaking OD readings 11 Insert it in the reading chamber carefully ensuring that the arrow mark on the Blanking Cuvette aligns with the arrow mark nextto the reading chamber of the Analyzer and press NE XT 12 After Blanking enter the lot number details of the Barcoded Cuvette A black cap in the Analyzer followed by the expiry details which is also mentioned on the Barcoded Cuvette A black cap in the Analyzer and press NE XT 13 The main
20. the adjusted inoculum dip a sterile cotton swab Steristik C atno AC0003 into the inoculum R otate the swab several times and press firmly on the inside wall of the tube above the fluid level to remove excess inoculum from the swab Streak the swab over the entire surface of the Mueller Hinton agar plate Rotate the plate approximately 60 then repeat streaking motion R otate 60 again and repeat streaking for the third time Complete inoculation by running the swab around the rim of the agar Step 3 Dispense the required number of antibiotic disks to the agar surface with a sterile forcep or disc dispenser forceps can be sterilized by flaming with alcohol Avoid using over heated forceps Do not relocate any antibiotic disk after contact with the agar After application ensure that the antibiotic disk has made complete contact with the agar surface by touching the top ofthe disk with forceps Antibiotic discs Biogram recommended for UTI pathogens as per CLS1 are available with MICROXPRESS Refer antibiotics listmentioned in Section 16 Step 4 Keep the plates in the incubator setat 35 37 C for overnight and then look for zone of inhibition as perCLSI guidelines ReferBiogram Packinsertfor detailed AST analysis 13 QUALITY CONTROL PROCEDURES Quality control of MICROPRO BCS system can be performed with MICROPRO UTI Control kit which is available separately CatNoMSQC01 Quality control is to be performed for e
21. tination test J Clin Microbiol Nov 1980 12 5 641 643 14 Kloos W E and P B Smith Staphylococci 1980 Manual of Clinical Microbiology 3rd ed E H Lennette A Balows W J Hausler Jr and J P Truant ed ASM Washington D C 15 Finegold S M and E E Sweeney 1961 New Selective and Differential Medium for Coagulase P ositive Staphylococci Allowing Rapid Growth and Stain Differentiation J Bacteriol 81 636 641 16 Data on file Microxpress P Ltd acCartney Vol 2 13 th ed Churchill Livingston 1989 5 TESTPRINCIPLE CAT NO ANTIMICROBIAL AGENT SYMBOL DISC CONTENT PACK SIZE The entire system is based on three fundamentals es Se a ea ee E el a Proprietary broth culture medium to support growth of typical UTI pathogens Ah Fosfomycin FE 200 mcg ae b Detection and enumeration of UTI based on Turbidimetry FF0001 Single via c Identification of the UTI pathogen based on well characterized biochemical tests GENT10 5 Carts GENV10 Gentamicin GEN 10 mcg 5 Vials Urine Specimen GENO01 Single via IPMT10 5 Carts sal 100p IPMV10 Imipenem IPM 10 mcg 5 Vials IPM001 Single Via LET5 5 Carts a Step 1 Inoculate same Urine Specimen in Barcoded Cuvette A amp Test Vial B LEV5 Levofloxacin LE 5 mcg 5 Vials LEO1 Single Via Barcoded Cuvette A l Test Vial Fizo a
22. ults expected for the urine samples in MICROPRO BCS Analyzer and based on these results further action is recommended Result reported in S No MICROPRO Bcs Mterpretation of the Further Action Analyzer 1 Negative Negative for UTI No further action required Report with printout of result Proceed for Biochemical identification testing as recommended in Biochemical ID Kit packinsert Threshold or Evolving 3 5 2 10 lt 10 CFU ml UTI infection 3 10 lt 10 CFU ml Positive Frank UTI Proceed for Biochemical identification testing as recommended in Positive Frank UTI with Biochemical ID Kit packinsert High Count 4 10 lt 10 CFU ml Proceed for Biochemical identification Very High Count testing as recommended in 8 5 gt 10 CFU ml Mixed infection possible Biochemical ID Kit packinsert Negative Testresults gt TheBarcoded Cuvettes A with Negative results along with its Test Vials B are to be discarded as per local disposal guidelines and sample to be reported negative with printout of the result Positive Testresults gt The Barcoded C uvette A with Positive results along with the corresponding Test Vial B are to be retained in the Cuvette stand and then proceed for Biochemical identification testing using MICROPRO ID Kit Note a 0Ds displayed on the instrumentscreen are for indicative purpose only 11 BIOCHEMICAL IDENTIFICATI
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