M E D I C A L L A B O R A T O R Y
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1 M E D I C A L L A B O R A T O R Y E V A L U A T I O N PARTICIPANT SUMMARY Microbiology MLE-M1 Total Commitment to Education and Service Provided by ACP, Inc.
2 Evaluation Criteria... 2 Microbiology Table of Contents Throat Culture... 3 GC (Antigen Detection) Strep A Antigen Detection... 4 Cryptosporidium Antigen Detection General Bacteriology... 8 Giardia lamblia Antigen Detection MRSA Screening... 9 RSV Antigen Detection Urine Culture Influenza A/B Antigen Detection Gram Stain Influenza A Antigen Detection Antimicrobial Susceptibility Testing Influenza B Antigen Detection Genital Culture Legionella Antigen Detection Gram Stain Clostridium Difficile Toxin Antigen Detection Colony Count/Presumptive ID Rotavirus Antigen Detection Gram Stain Streptococcus pneumoniae Antigen Detection Dermatophyte Screen Parasitology Gram Stain Affirm VP III Trichomonas vaginalis Gardnerella vaginalis Candida sp Chlamydia (Antigen Detection) Evaluation Criteria The evaluation criteria used in the MLE Program is in accordance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA 88) federal requirements for proficiency testing. The criteria are included below. Qualitative For qualitative procedures, evaluation is based on participant or referee consensus. If participant consensus is not reached, CMS requirements call for grading by referee consensus. A minimum percentage of participants or referee laboratories must receive a passing score or the challenge is not evaluated due to lack of consensus. These percentages are listed below. Affirm VP III Candida Antigen Detection 80% Consensus Influenza A Antigen Detection 80% Consensus Affirm VP III Gardnerella Ag Detection 80% Consensus Influenza A/B Antigen Detection 80% Consensus Affirm VP III Trichomonas Ag Detection 80% Consensus Influenza B Antigen Detection 80% Consensus Antimicrobial Susceptibility Testing 80% Consensus Legionella Antigen Detection 80% Consensus Bacterial Identification 80% Consensus Parasite Identification 80% Consensus C. difficile Toxin/Antigen Detection 80% Consensus Rotavirus Antigen Detection 80% Consensus Chlamydia (EIA, DNA) 80% Consensus RSV Antigen Detection 80% Consensus Colony Count 80% Consensus Strep A Antigen Detection 80% Consensus Cryptosporidium Antigen Detection 80% Consensus Streptococcus pneumoniae Antigen Detection 80% Consensus Dermatophyte Screen 80% Consensus Urine Presumptive Identification 80% Consensus GC (EIA, DNA) 80% Consensus Giardia lamblia Antigen Detection 80% Consensus Gram Stain 80% Consensus Gram Stain Morphology 80% Consensus COPYRIGHT ACP, Inc. Single copies of all material subject to this copyright may be photocopied for the non-commercial use of scientific or educational advancement.
3 THROAT CULTURE Specimen TC-1 Positive for Group A Strep % Acceptable Presump. Pos. Group A Strep % Acceptable Streptococcus pyogenes % Acceptable Presumptive Streptococcus species % Acceptable Negative for Group A Strep % Organisms present in specimen TC-1: Streptococcus pyogenes and Streptococcus viridans. Specimen TC-2 Negative for Group A Strep % Acceptable Haemophilus influenzae % Acceptable No growth (sterile) % Organism present in specimen TC-2: Haemophilus influenzae Specimen TC-3 Positive for Group A Strep % Acceptable Presump. Pos. Group A Strep % Acceptable Presumptive Strepococcus sp % Acceptable Organism present in specimen TC-3: Streptococcus pyogenes. Specimen TC-4 Negative for Group A Strep % Acceptable Organisms present in specimen TC-4: Moraxella catarrhalis and Staphylococcus epidermidis. Specimen TC-5 Negative for Group A Strep % Acceptable No growth (sterile) % Acceptable Organism present in specimen TC-5: No organism present MLE-M1 Participant Summary/ 3
4 STREP A ANTIGEN DETECTION Specimen RS-1 ALL METHODS Abbott Signify Strep A-waived 3-3 Alere Acceava Strep A Test Alere Signify Strep A Dipstick 1-1 BD Chek Strep A 4-4 BD Veritor - waived 2-2 Beckman Coulter ICON DS 2-2 Beckman Coulter ICON SC 4-4 Binax NOW Strep A 6-6 Cardinal Health Strep A - waived Consult Diagnostic Strep A - Moderate 1-1 Consult Diagnostic Strep A Dipstick - Waived Fisher HealthCare Sure-Vue - waived 1-1 Henry Schein One Step+ - waived Immunostics Detector Strep A Direct McKesson Strep A Dipstick Meridian Illumigene 1-1 Other Moderately Complex Method 1-1 Other Waived Method Polymedco Poly Stat Strep A - moderate 1-1 Polymedco Poly Stat Strep A - waived 8-8 PSS Select Diag. Strep A Dipstick - waived 2-2 Quidel QuickVue Dipstick Strep Quidel QuickVue In-Line Quidel QuickVue Quidel Sofia - moderate 4-4 Sekisui OSOM Sekisui OSOM Ultra Strep A / 2015 MLE-M1 Participant Summary
5 STREP A ANTIGEN DETECTION Specimen RS-2 ALL METHODS Abbott Signify Strep A-waived Alere Acceava Strep A Test Alere Signify Strep A Dipstick BD Chek Strep A BD Veritor - waived Beckman Coulter ICON DS Beckman Coulter ICON SC Binax NOW Strep A Cardinal Health Strep A - waived Consult Diagnostic Strep A - Moderate Consult Diagnostic Strep A Dipstick - Waived Fisher HealthCare Sure-Vue - waived Henry Schein One Step+ - waived Immunostics Detector Strep A Direct McKesson Strep A Dipstick Meridian Illumigene Other Moderately Complex Method Other Waived Method Polymedco Poly Stat Strep A - moderate Polymedco Poly Stat Strep A - waived PSS Select Diag. Strep A Dipstick - waived Quidel QuickVue Dipstick Strep Quidel QuickVue In-Line Quidel QuickVue Quidel Sofia - moderate Sekisui OSOM Sekisui OSOM Ultra Strep A MLE-M1 Participant Summary/ 5
6 STREP A ANTIGEN DETECTION Specimen RS-3 ALL METHODS Alere Acceava Strep A Test 2-2 BD Chek Strep A 2-2 BD Veritor - waived 1-1 Beckman Coulter ICON DS 1-1 Beckman Coulter ICON SC 1-1 Binax NOW Strep A 1-1 Cardinal Health Strep A - waived 2-2 Consult Diagnostic Strep A - Moderate 1-1 Consult Diagnostic Strep A Dipstick - Waived 6-6 Henry Schein One Step+ - waived 6-6 McKesson Strep A Dipstick Other Waived Method 2-2 Polymedco Poly Stat Strep A - moderate 1-1 Quidel QuickVue Dipstick Strep Quidel QuickVue In-Line Quidel QuickVue Quidel Sofia - moderate 4-4 Sekisui OSOM 3-3 Sekisui OSOM Ultra Strep A / 2015 MLE-M1 Participant Summary
7 STREP A ANTIGEN DETECTION Specimen RS-4 ALL METHODS Alere Acceava Strep A Test BD Chek Strep A BD Veritor - waived Beckman Coulter ICON DS Beckman Coulter ICON SC Binax NOW Strep A Cardinal Health Strep A - waived Consult Diagnostic Strep A - Moderate Consult Diagnostic Strep A Dipstick - Waived Henry Schein One Step+ - waived McKesson Strep A Dipstick Other Waived Method Quidel QuickVue Dipstick Strep Quidel QuickVue In-Line Quidel QuickVue Quidel Sofia - moderate Sekisui OSOM Sekisui OSOM Ultra Strep A Specimen RS-5 ALL METHODS Alere Acceava Strep A Test BD Chek Strep A BD Veritor - waived Beckman Coulter ICON DS Beckman Coulter ICON SC Binax NOW Strep A Cardinal Health Strep A - waived Consult Diagnostic Strep A - Moderate Consult Diagnostic Strep A Dipstick - Waived Henry Schein One Step+ - waived McKesson Strep A Dipstick Other Waived Method Quidel QuickVue Dipstick Strep Quidel QuickVue In-Line Quidel QuickVue Quidel Sofia - moderate Sekisui OSOM Sekisui OSOM Ultra Strep A MLE-M1 Participant Summary/ 7
8 GENERAL BACTERIOLOGY Specimen BA-1 Blood Culture Streptococcus alpha-hemolytic % Acceptable Streptococcus viridans % Acceptable Organism present in specimen BA-1: Streptococcus sanguinis. This specimen was graded by 80% referee consensus. Specimen BA-2 Respiratory Culture Streptococcus pneumonia % Acceptable Corynebacterium species % Acceptable Organisms present in specimen BA-2: Streptococcus pneumoniae and Corynebacterium species. Specimen BA-3 Wound Culture Escherichia coli % Acceptable Growth, referred for identification % Acceptable Bacteroides fragilis % Acceptable Anaerobic cultures not performed would refer % Acceptable Organisms present in specimen BA-3: Escherichia coli and Bacteroides fragilis. 8 / 2015 MLE-M1 Participant Summary
9 METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS SCREEN Specimen MSA-1 Positive 5 100% Acceptable Organisms present in specimen MSA-1 Staphylococcus aureus Methicillin resistant and Streptococcus pneumoniae. Specimen MSA-2 Negative 5 100% Acceptable Organisms present in specimen MSA-2: Moraxella catarrhalis and Staphylococcus epidermidis. Specimen MSA-3 Positive 5 100% Acceptable Organisms present in specimen MSA-3: Staphylococcus aureus Methicillin resistant and Corynebacterium species. Specimen MSA-4 Positive 5 100% Acceptable Organisms present in specimen MSA-4: Staphylococcus aureus Methicillin resistant and Streptococcus viridans. Specimen MSA-5 Negative 5 100% Acceptable Organisms present in specimen MSA-5: Haemophilus influenzae and Neisseria sicca MLE-M1 Participant Summary/ 9
10 URINE CULTURE Specimen UC-1 Staphlyococcus aureus % Acceptable Growth, referred for identification % Acceptable Gram positive cocci % Acceptable Presump. Staphlyococcus species % Acceptable Staphylococcus species % Acceptable Presump. Gram positive % Acceptable Gram Stain Gram positive % Acceptable Gram negative % Gram Stain Morphology Cocci % Acceptable Organism present in specimen UC-1: Staphylococcus aureus. Specimen UC-2 Klebsiella oxytoca % Acceptable Growth, referred for identification % Acceptable Gram negative bacilli % Acceptable Klebsiella species % Acceptable Staphylococcus epidermidis % Acceptable Staphylococcus species % Acceptable Presump. Gram negative % Acceptable Presump. Klebsiella species % Acceptable Organisms present in specimen UC-2: Klebsiella oxytoca and Staphylococcus epidermidis. Specimen UC-3 Enterobacter species % Acceptable Growth, referred for identification % Acceptable Enterobacter cloacae % Acceptable Gram negative bacilli % Acceptable Presump. Gram negative % Acceptable Presump. Enterobacter species % Acceptable Corynebacterium species % Acceptable Organisms present in specimen UC-3: Enterobacter cloacae and Corynebacterium species. 10 / 2015 MLE-M1 Participant Summary
11 URINE CULTURE Specimen UC-4 Streptococcus agalactiae % Acceptable Growth, referred for identification % Acceptable Presump. Gram positive % Acceptable Presumptive Streptococcus species % Acceptable Strep beta hemo; not Grp A % Acceptable Organisms present in specimen UC-4: Streptococcus agalactiae and Lactobacillus species. Specimen UC-5 Escherichia coli % Acceptable Growth, referred for identification % Acceptable Presump. Escherichia coli % Acceptable Presump. Gram negative % Acceptable Organism present in specimen UC-5: Escherichia coli MLE-M1 Participant Summary/ 11
12 ANTIMICROBIAL SUSCEPTIBILIY TESTING Specimen UC-1, CC-1 (SUS-1) The organism present is: Staphylococcus aureus Disk Diffusion MIC Interpretative category data Interpretative category data Antimicrobial Labs S I R Labs S I R Acceptable (%) Amoxicillin/Clavulanate % Ampicillin % Ampicillin/Sulbactam Not graded 1 Cefazolin % Cefepime Not graded 1 Cefotaxime Not graded 1 Cefoxitin % Ceftazidime Inappropriate drug 2 Ceftriaxone % Cefuroxime % Cephalothin % Ciprofloxacin % Daptomycin Not graded 1 Doxycycline Not graded 1 Ertapenem Not graded 1 Gatifloxacin Not graded 1 Gentamicin % Imipenem Not graded 1 Levofloxacin % Linezolid % Moxifloxacin Not graded 1 Nitrofurantoin % Ofloxacin Not graded 1 Oxacillin % Penicillin % Quinupristin/Dalfopristin Not graded 1 Rifampin % Sulfisoxazole Not graded 1 Tetracycline % Trimethoprim Not graded 1 Trimethoprim/Sulfamethoxazole % Vancomycin % NOTE: Please be aware that CLSI may issue a new edition of the supplement to the standards used by all proficiency testing programs for grading of susceptibilities as often as annually. Please contact CLSI to ensure that you are using the most recent version of these standards when reporting your susceptibilities. MLE has observed significant changes to which drugs are considered appropriate for various organisms with each subsequent supplement editions. 1 This is an ungraded challenge due to lack of comparison group. 2 This is an inappropriate drug for organism and/or source. 12 / 2015 MLE-M1 Participant Summary
13 GENITAL CULTURE Specimen GC-1 Presumptive for N. gonorrhoeae % Acceptable Neisseria gonorrhoeae % Acceptable Gram negative diplococci % Acceptable Gram Stain Gram negative % Acceptable Gram Stain Morphology Diplococci % Acceptable Organism present in specimen GC-1: Neisseria gonorrhoeae. Specimen GC-2 Negative for N. gonorrhoeae % Acceptable Gram positive cocci % Acceptable Organism present in specimen GC-2: Staphylococcus aureus. Specimen GC-3 Negative for N. gonorrhoeae % Acceptable Gram positive cocci % Acceptable Organisms present in specimen GC-3: Enterococcus faecalis and Lactobacillus species MLE-M1 Participant Summary/ 13
14 GENITAL CULTURE Specimen GC-4 Presumptive for N. gonorrhoeae % Acceptable Neisseria gonorrhoeae % Acceptable Organisms present in specimen GC-4: Neisseria gonorrhoeae and Staphylococcus epidermidis. Specimen GC-5 Negative for N. gonorrhoeae % Acceptable No growth (sterile) % Acceptable Organism present in specimen GC-5: No growth (sterile). 14 / 2015 MLE-M1 Participant Summary
15 COLONY COUNT/PRESUMPTIVE IDENTIFICATION Specimen CC-1 Method Labs No growth <10,000 organisms/ml 10, ,000 organisms/ml >100,000 organisms/ml ALL METHODS Bulls Eye Calibrated Loop Dip-N-Count HealthLink Troy Bacti-Urine, Plate Uri-Check Uricult Identification Specimen CC-1 Presump. Gram positive % Acceptable Growth, referred for identification % Acceptable Presump. Staphylococcus species % Acceptable Staphylococcus aureus % Acceptable Organism present in specimen CC-1: >100,000 CFU/mL of Staphylococcus aureus. COLONY COUNT/PRESUMPTIVE IDENTIFICATION Specimen CC-2 Method Labs No growth <10,000 organisms/ml 10, ,000 organisms/ml >100,000 organisms/ml ALL METHODS Bulls Eye Calibrated Loop Dip-N-Count HealthLink Troy Bacti-Urine, Plate Uri-Check Uricult Identification Specimen CC-2 Presump. Gram negative % Acceptable Growth, referred for identification % Acceptable Klebsiella oxytoca % Acceptable Gram negative bacilli % Acceptable Presump. Klebsiella species % Acceptable Presmp. Gram positive % Acceptable Staphylococcus epidermidis % Acceptable Organisms present in specimen CC-2: 50,000-75,000 CFU/mL of Klebsiella oxytoca and <10,000 CFU/mL of Staphylococcus epidermidis MLE-M1 Participant Summary/ 15
16 COLONY COUNT/PRESUMPTIVE IDENTIFICATION Identification Specimen CC-3 Presump. Gram negative % Acceptable Growth, referred for identification % Acceptable Presump. Enterobacter species % Acceptable Enterobacter cloacae % Acceptable Gram negative bacilli % Acceptable Organisms present in specimen CC-3: 50,000-75,000 CFU/mL of Enterobacter cloacae and <10,000 CFU/mL of Corynebacterium species. Identification Specimen CC-4 Presump. Gram positive % Acceptable Growth, referred for identification % Acceptable Strep beta hemo: not Grp A % Acceptable Streptococcus agalactiae % Acceptable Presumptive Streptococcus species % Acceptable Organisms present in specimen CC-4: >100,000 CFU/mL of Streptococcus agalactiae and <10,000 CFM/mL of Lactobacillus species. This specimen was graded by 82% referee consensus. Identification Specimen CC-5 Presump. Gram negative % Acceptable Growth, referred for identification % Acceptable Presump. Escherichia coli % Acceptable Escherichia coli % Acceptable Organism present in specimen CC-5: >100,000 CFU/mL of Escherichia coli. 16 / 2015 MLE-M1 Participant Summary
17 DERMATOPHYTE SCREEN Specimen DM-1 Dermatophyte absent % Acceptable Dermatophyte present % Organism present in specimen DM-1: Staphylococcus aureus. Specimen DM-2 Dermatophyte present % Acceptable Dermatophyte absent % Organism present in specimen DM-2: Epidermophyton floccosum. This specimen was graded by 80% referee consensus. GRAM STAIN Specimen GS-1 Reaction Labs Percent Performance Gram negative % Acceptable Gram Stain Morphology Rods/bacilli % Acceptable Coccobacilli % Organism present in specimen GS-1: Escherichia coli. Specimen GS-2 Reaction Labs Percent Performance Gram negative % Acceptable Gram positive % Gram Stain Morphology Diplococci % Acceptable Cocci % Acceptable Organism present in specimen GS-2: Moraxella catarrhalis MLE-M1 Participant Summary/ 17
18 GRAM STAIN Specimen GS-3 Reaction Labs Percent Performance Gram positive % Acceptable Gram negative % Gram Stain Morphology Cocci % Acceptable Diplococci % Organism present in specimen GS-3: Staphylococcus aureus. Specimen GS-4 Reaction Labs Percent Performance Gram negative % Acceptable Gram Stain Morphology Rods/bacilli % Acceptable Coccobacilli % Organism present in specimen GS-4: Proteus valgaris. Specimen GS-5 Reaction Labs Percent Performance Gram positive % Acceptable Gram negative % Gram Stain Morphology Cocci % Acceptable Diplococci % Organism present in specimen GS-5: Streptococcus agalactiae. 18 / 2015 MLE-M1 Participant Summary
19 AFFIRM VP III Trichomonas vaginalis Specimen VP-1 Negative % Acceptable Organism present in specimen VP-1: Candida albicans. Specimen VP-2 Negative % Acceptable Organism present in specimen VP-2: Gardnerella vaginalis. Specimen VP-3 Positive % Acceptable Organisms present in specimen VP-3: Gardnerella vaginalis and Trichomonas vaginalis. Specimen VP-4 Negative % Acceptable Positive % Organism present in specimen VP-4: No organism present. Specimen VP-5 Positive % Acceptable Negative % Organism present in specimen VP-5: Trichomonas vaginalis MLE-M1 Participant Summary/ 19
20 AFFIRM VP III Gardnerella vaginalis Specimen VP-1 Negative % Acceptable Specimen VP-2 Positive % Acceptable Specimen VP-3 Positive % Acceptable Specimen VP-4 Negative % Acceptable Specimen VP-5 Negative % Acceptable Positive % AFFIRM VP III Candida sp. Specimen VP-1 Positive % Acceptable Specimen VP-2 Negative % Acceptable 20 / 2015 MLE-M1 Participant Summary
21 AFFIRM VP III Candida sp. Specimen VP-3 Negative % Specimen VP-4 Negative % Acceptable Specimen VP-5 Negative % Acceptable CHLAMYDIA (ANTIGEN DETECTION) Specimen CY-1 ALL METHODS BD ProbeTec Gen-Probe APTIMA Quidel QuickVue Roche COBAS Amplicor Organism present in specimen CY-1: Chlamydia trachomatis. Specimen CY-2 ALL METHODS BD ProbeTec 4-4 Gen-Probe APTIMA 2-2 Quidel QuickVue 6-6 Roche COBAS Amplicor 2-2 Organism present in specimen CY-2: Neisseria gonorrhoeae MLE-M1 Participant Summary/ 21
22 CHLAMYDIA (ANTIGEN DETECTION) Specimen CY-3 ALL METHODS BD ProbeTec 4-4 Gen-Probe APTIMA 2-2 Quidel QuickVue 4-4 Roche COBAS Amplicor 2-2 Organism present in specimen CY-3: Neisseria gonorrhea. Specimen CY-4 ALL METHODS BD ProbeTec Gen-Probe APTIMA Quidel QuickVue Roche COBAS Amplicor Organisms present in specimen CY-4: Chlamydia trachomatis and Neisseria gonorrhea. Specimen CY-5 ALL METHODS BD ProbeTec Gen-Probe APTIMA Quidel QuickVue Roche COBAS Amplicor Organism present in specimen CY-5: Chlamydia trachomatis. 22 / 2015 MLE-M1 Participant Summary
23 GC (ANTIGEN DETECTION) Specimen CY-1 ALL METHODS 9-9 BD ProbeTec 4-4 Gen-Probe APTIMA 2-2 Roche COBAS Amplicor 2-2 Specimen CY-2 ALL METHODS BD ProbeTec Gen-Probe APTIMA Roche COBAS Amplicor Specimen CY-3 ALL METHODS BD ProbeTec Gen-Probe APTIMA Roche COBAS Amplicor Specimen CY-4 ALL METHODS BD ProbeTec Gen-Probe APTIMA Roche COBAS Amplicor Specimen CY-5 ALL METHODS BD ProbeTec 4-4 Gen-Probe APTIMA 2-2 Roche COBAS Amplicor MLE-M1 Participant Summary/ 23
24 CRYPTOSPORIDIUM ANTIGEN DETECTION Specimen LC-1 ALL METHODS Alere Giardia/Crypto Quik Chek Antigens present in specimen LC-1: Cryptosporidium and Giardia lamblia. Specimen LC-2 ALL METHODS Alere Giardia/Crypto Quik Chek Antigen present in specimen LC-2: Cryptosporidium. Specimen LC-3 ALL METHODS 1-1 Alere Giardia/Crypto Quik Chek 1-1 Antigen present in specimen LC-3: Giardia lamblia. Specimen LC-4 ALL METHODS 1-1 Alere Giardia/Crypto Quik Chek 1-1 Antigen present in specimen LC-4: No antigens present. Specimen LC-5 ALL METHODS Alere Giardia/Crypto Quik Chek Antigen present in specimen LC-5: Cryptosporidium. 24 / 2015 MLE-M1 Participant Summary
25 GIARDIA LAMBLIA ANTIGEN DETECTION Specimen LC-1 ALL METHODS Alere Giardia/Crypto Quik Chek Specimen LC-2 ALL METHODS 1-1 Alere Giardia/Crypto Quik Chek 1-1 Specimen LC-3 ALL METHODS Alere Giardia/Crypto Quik Chek Specimen LC-4 ALL METHODS 1-1 Alere Giardia/Crypto Quik Chek 1-1 Specimen LC-5 ALL METHODS 1-1 Alere Giardia/Crypto Quik Chek MLE-M1 Participant Summary/ 25
26 RSV ANTIGEN DETECTION Specimen V-1 ALL METHODS Alere Binax NOW - waived Alere Clearview RSV - waived Quidel QuickVue RSV - waived 7-7 Quidel QuickVue RSV 10 Test 1-1 Quidel Sofia - waived 7-7 Antigen present in specimen V-1: Influenza A. Specimen V-2 ALL METHODS Alere Binax NOW - waived Alere Clearview RSV - waived Quidel QuickVue RSV - waived Quidel QuickVue RSV 10 Test 1-1 Quidel Sofia - waived 7-7 Antigen present in specimen V-2: Influenza B. Specimen V-3 ALL METHODS Alere Binax NOW - waived Alere Clearview RSV - waived Quidel QuickVue RSV - waived Quidel QuickVue RSV 10 Test Quidel Sofia - waived Antigen present in specimen V-3: RSV. Specimen V-4 ALL METHODS Alere Binax NOW - waived 5-5 Alere Clearview RSV - waived Quidel QuickVue RSV - waived 3-3 Quidel QuickVue RSV 10 Test 1-1 Quidel Sofia - waived 5-5 Antigen present in specimen V-4: Influenza A. 26 / 2015 MLE-M1 Participant Summary
27 RSV ANTIGEN DETECTION Specimen V-5 ALL METHODS Alere Binax NOW - waived Alere Clearview RSV - waived Quidel QuickVue RSV - waived Quidel QuickVue RSV 10 Test Quidel Sofia - waived Antigen present in specimen V-5: RSV. INFLUENZA A/B ANTIGEN DETECTION Specimen V-1 ALL METHODS Quidel QuickVue Influenza Sekisui OSOM Influenza A&B Antigen present in specimen V-1: Influenza A. Specimen V-2 ALL METHODS Quidel QuickVue Influenza Sekisui OSOM Influenza A&B Antigen present in specimen V-2: Influenza B. Specimen V-3 ALL METHODS Quidel QuickVue Influenza Antigen present in specimen V-3: RSV. Specimen V-4 ALL METHODS Quidel QuickVue Influenza Antigen present in specimen V-4: Influenza A MLE-M1 Participant Summary/ 27
28 INFLUENZA A/B ANTIGEN DETECTION Specimen V-5 ALL METHODS Quidel QuickVue Influenza Antigen present in specimen V-5: RSV. INFLUENZA A ANTIGEN DETECTION Specimen V-1 ALL METHODS Alere Binax NOW - waived Alere Influenza A&B BD Veritor - waived Henry Schein OneStep+ Flu A&B Labsco Advantage Flu A&B Medline Influenza A&B OraSure QuickFlu Quidel QuickVue Influenza A+B Quidel Sofia - waived Remel Xpect Antigen present in specimen V-1: Influenza A. Specimen V-2 ALL METHODS Alere Binax NOW - waived Alere Influenza A&B 4-4 BD Veritor - waived Henry Schein OneStep+ Flu A&B 2-2 Labsco Advantage Flu A&B 1-1 Medline Influenza A&B 2-2 OraSure QuickFlu 2-2 Quidel QuickVue Influenza A+B Quidel Sofia - waived Remel Xpect 2-2 Sekisui OSOM Influenza A&B Antigen present in specimen V-2: Influenza B. 28 / 2015 MLE-M1 Participant Summary
29 INFLUENZA A ANTIGEN DETECTION Specimen V-3 ALL METHODS Alere Binax NOW - waived BD Veritor - waived 4-4 Labsco Advantage Flu A&B 1-1 Quidel QuickVue Influenza A+B 3-3 Quidel Sofia - waived 9-9 Remel Xpect 2-2 Sekisui OSOM Influenza A&B Antigen present in specimen V-3: RSV. Specimen V-4 ALL METHODS Alere Binax NOW - waived BD Veritor - waived Labsco Advantage Flu A&B Quidel QuickVue Influenza A+B Quidel Sofia - waived Remel Xpect Sekisui OSOM Influenza A&B Antigen present in specimen V-4: Influenza A. Specimen V-5 ALL METHODS Alere Binax NOW - waived BD Veritor - waived 4-4 Labsco Advantage Flu A&B 1-1 Quidel QuickVue Influenza A+B 3-3 Quidel Sofia - waived 9-9 Remel Xpect 2-2 Sekisui OSOM Influenza A&B Antigen present in specimen V-5: RSV MLE-M1 Participant Summary/ 29
30 INFLUENZA B ANTIGEN DETECTION Specimen V-1 ALL METHODS Alere Binax NOW - waived Alere Influenza A&B 4-4 BD Veritor - waived Henry Schein OneStep+ Flu A&B 2-2 Labsco Advantage Flu A&B 1-1 Medline Influenza A&B 2-2 OraSure QuickFlu 2-2 Quidel QuickVue Influenza A+B Quidel Sofia - waived Remel Xpect 3-3 Sekisui OSOM Influenza A&B Antigen present in specimen V-1: Influenza A. Specimen V-2 ALL METHODS Alere Binax NOW - waived Alere Influenza A&B BD Veritor - waived Henry Schein OneStep+ Flu A&B Labsco Advantage Flu A&B Medline Influenza A&B OraSure QuickFlu Quidel QuickVue Influenza A+B Quidel Sofia - waived Remel Xpect Sekisui OSOM Influenza A&B Antigen present in specimen V-2: Influenza B. Specimen V-3 ALL METHODS Alere Binax NOW - waived BD Veritor - waived 3-3 Labsco Advantage Flu A&B 1-1 Quidel QuickVue Influenza A+B 3-3 Quidel Sofia - waived 8-8 Remel Xpect 3-3 Sekisui OSOM Influenza A&B Antigen present in specimen V-3: RSV. 30 / 2015 MLE-M1 Participant Summary
31 INFLUENZA B ANTIGEN DETECTION Specimen V-4 ALL METHODS Alere Binax NOW - waived BD Veritor - waived 3-3 Labsco Advantage Flu A&B 1-1 Quidel QuickVue Influenza A+B 3-3 Quidel Sofia - waived 8-8 Remel Xpect 3-3 Sekisui OSOM Influenza A&B Antigen present in specimen V-4: Influenza A. Specimen V-5 ALL METHODS Alere Binax NOW - waived BD Veritor - waived 3-3 Labsco Advantage Flu A&B 1-1 Quidel QuickVue Influenza A+B 3-3 Quidel Sofia - waived Remel Xpect 3-3 Sekisui OSOM Influenza A&B Antigen present in specimen V-5: RSV MLE-M1 Participant Summary/ 31
32 LEGIONELLA ANTIGEN DETETION Specimen L-1 Binax NOW Specimen L-1: Positive for Legionella antigen. Specimen L-2 Binax NOW Specimen L-2: Positive for Legionella antigen. Specimen L-3 Binax NOW Specimen L-3: Positive for Legionella antigen. Specimen L-4 Binax NOW Specimen L-4: Negative for Legionella antigen. Specimen L-5 Binax NOW Specimen L-5: Negative for Legionella antigen. 32 / 2015 MLE-M1 Participant Summary
33 CLOSTRIDIUM DIFFICILE TOXIN ANTIGEN DETECTION Specimen AG-1 ALL METHODS Alere C. diff Quik Chek Meridian Illumigene Meridian Premier Antigens present in specimen AG-1: Clostridium difficile and Rotavirus. Specimen AG-2 ALL METHODS 8-8 Alere C. diff Quik Chek 6-6 Meridian Illumigene 1-1 Meridian Premier 1-1 Antigen present in specimen AG-2: Rotavirus. Specimen AG-3 ALL METHODS 8-8 Alere C. diff Quik Chek 6-6 Meridian Illumigene 1-1 Meridian Premier 1-1 Antigen present in specimen AG-3: No antigens present. Specimen AG-4 ALL METHODS Alere C. diff Quik Chek Meridian Illumigene Meridian Premier Antigen present in specimen AG-4: Clostridium difficile MLE-M1 Participant Summary/ 33
34 CLOSTRIDIUM DIFFICILE TOXIN ANTIGEN DETECTION Specimen AG-5 ALL METHODS 8-8 Alere C. diff Quik Chek 6-6 Meridian Illumigene 1-1 Meridian Premier 1-1 Antigen present in specimen AG-5: Rotavirus. ROTAVIRUS ANTIGEN DETECTION Specimen AG-1 ALL METHODS Fisher HealthCare Sure-Vue Specimen AG-2 ALL METHODS Fisher HealthCare Sure-Vue Specimen AG-3 ALL METHODS 5-5 Fisher HealthCare Sure-Vue 5-5 Specimen AG-4 ALL METHODS 5-5 Fisher HealthCare Sure-Vue / 2015 MLE-M1 Participant Summary
35 ROTAVIRUS ANTIGEN DETECTION Specimen AG-5 ALL METHODS Fisher HealthCare Sure-Vue STREPTOCOCCUS PNEUMONIAE ANTIGEN Specimen SP-1 Binax NOW Specimen SP-1: Negative for Streptococcus pneumoniae antigen. Specimen SP-2 Binax NOW Specimen SP-2: Positive for Streptococcus pneumoniae antigen. Specimen SP-3 Binax NOW Specimen SP-3: Positive for Streptococcus pneumoniae antigen. Specimen SP-4 Binax NOW Specimen SP-4: Negative for Streptococcus pneumoniae antigen. Specimen SP-5 Binax NOW Specimen SP-5: Positive for Streptococcus pneumoniae antigen MLE-M1 Participant Summary/ 35
36 PARASITOLOGY Specimen PA-1 No parasite seen 1 100% Acceptable Parasite present in specimen PA-1: No parasite present. Specimen PA-2 Entamoeba coli 1 100% Acceptable Parasite present in specimen PA-2: Entamoeba coli. Specimen PA-3 Ascaris lumbricoides eggs 1 100% Acceptable Parasite present in specimen PA-3: Ascaris lumbricoides eggs. Specimen PA-4 Balantidium coli 1 100% Acceptable Parasite present in specimen PA-4: Balantidium coli. Specimen PA-5 Balantidium coli 1 100% Acceptable Parasite present in specimen PA-5: Balantidum coli. Medical Laboratory Evaluation 25 Massachusetts Ave NW Ste 700 Washington, DC Fax: / 2015 MLE-M1 Participant Summary
M E D I C A L L A B O R A T O R Y
M E D I C A L L A B O R A T O R Y E V A L U A T I O N PARTICIPANT SUMMARY 2 0 1 7 Microbiology 2017 MLE-M1 Total Commitment to Education and Service Provided by ACP, Inc. Evaluation Criteria... 2 Microbiology
M E D I C A L L A B O R A T O R Y
M E D I C A L L A B O R A T O R Y E V A L U A T I O N PARTICIPANT SUMMARY 2 0 1 6 Microbiology 2016 MLE-M1 Total Commitment to Education and Service Provided by ACP, Inc. Evaluation Criteria... 2 Microbiology
M E D I C A L L A B O R A T O R Y
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