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 2016 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 Negative for Group A Strep % Acceptable Streptococcus pneumoniae % Acceptable Streptococcus alpha-hemolytic % Acceptable Organism present in specimen TC-1: Streptococcus pneumoniae. Specimen TC-2 Positive for Group A Strep % Acceptable Presump. Pos. Group A Strep % Acceptable Streptococcus pyogenes % Acceptable Organism present in specimen TC-2: Streptococcus pyogenes. Specimen TC-3 Negative for Group A Strep % Acceptable Organisms present in specimen TC-3: Moraxella catarrhalis and Neisseria mucosa. Specimen TC-4 Negative for Group A Strep % Acceptable Organism present in specimen TC-4: Neisseria sicca. Specimen TC-5 Positive for Group A Strep % Acceptable Presump. Pos. Group A Strep % Acceptable Streptococcus pyogenes % Acceptable Organisms present in specimen TC-5: Streptococcus pyogenes and Staphylococcus epidermidis MLE-M1 Participant Summary/ 3
4 STREP A ANTIGEN DETECTION Specimen RS-1 ALL METHODS Abbott Signify Strep A-waived Alere Acceava Strep A Test Alere Clearview RSV - waived 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 Dipstick - Waived Fisher HealthCare Sure-Vue - waived Germaine Laboratories StrepAim Henry Schein One Step Henry Schein One Step+ - waived Immunostics Detector Strep A Direct McKesson Strep A Dipstick Other Waived Method 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 - waived Quidel Sofia Strep A - moderate Quidel Sofia Strep A+ - waived Sekisui OSOM Sekisui OSOM Ultra Strep A / 2016 MLE-M1 Participant Summary
5 STREP A ANTIGEN DETECTION Specimen RS-2 ALL METHODS Abbott Signify Strep A-waived 2-2 Alere Acceava Strep A Test Alere Clearview RSV - waived 1-1 Alere Signify Strep A Dipstick 1-1 BD Chek Strep A 3-3 BD Veritor - waived 8-8 Beckman Coulter ICON DS 3-3 Beckman Coulter ICON SC 4-4 Binax NOW Strep A 5-5 Cardinal Health Strep A - waived 5-5 Consult Diagnostic Strep A Dipstick - Waived Fisher HealthCare Sure-Vue - waived 1-1 Germaine Laboratories StrepAim 6-6 Henry Schein One Step 1-1 Henry Schein One Step+ - waived Immunostics Detector Strep A Direct 1-1 McKesson Strep A Dipstick Other Waived Method Polymedco Poly Stat Strep A - waived 5-5 PSS Select Diag. Strep A Dipstick - waived 4-4 Quidel QuickVue Dipstick Strep Quidel QuickVue In-Line Quidel QuickVue Quidel Sofia - waived 2-2 Quidel Sofia Strep A - moderate 1-1 Quidel Sofia Strep A+ - waived 8-8 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 BD Chek Strep A BD Veritor - waived Beckman Coulter ICON DS Beckman Coulter ICON SC Binax NOW Strep A Consult Diagnostic Strep A Dipstick - Waived Henry Schein One Step+ - waived McKesson Strep A Dipstick Other Waived Method PSS Select Diag. Strep A Dipstick - waived Quidel QuickVue Dipstick Strep Quidel QuickVue In-Line Quidel QuickVue Quidel Sofia Strep A - moderate Quidel Sofia Strep A+ - waived Sekisui OSOM Sekisui OSOM Ultra Strep A / 2016 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 Consult Diagnostic Strep A Dipstick - Waived Henry Schein One Step+ - waived McKesson Strep A Dipstick Other Waived Method PSS Select Diag. Strep A Dipstick - waived Quidel QuickVue Dipstick Strep Quidel QuickVue In-Line Quidel QuickVue Quidel Sofia Strep A - moderate Quidel Sofia Strep A+ - waived Sekisui OSOM Sekisui OSOM Ultra Strep A Specimen RS-5 ALL METHODS Alere Acceava Strep A Test 3-3 BD Chek Strep A 1-1 BD Veritor - waived 2-2 Beckman Coulter ICON DS 1-1 Beckman Coulter ICON SC 1-1 Binax NOW Strep A 1-1 Consult Diagnostic Strep A Dipstick - Waived Henry Schein One Step+ - waived 1-1 McKesson Strep A Dipstick 3-3 Other Waived Method 1-1 PSS Select Diag. Strep A Dipstick - waived 1-1 Quidel QuickVue Dipstick Strep Quidel QuickVue In-Line Quidel QuickVue+ 6-6 Quidel Sofia Strep A - moderate 1-1 Quidel Sofia Strep A+ - waived 1-1 Sekisui OSOM 1-1 Sekisui OSOM Ultra Strep A MLE-M1 Participant Summary/ 7
8 GENERAL BACTERIOLOGY Specimen BA-1 Fluid Culture Streptococcus agalactiae 8 100% Acceptable Organism present in specimen BA-1: Streptococcus agalactiae. Specimen BA-2 Respiratory Culture Burkholderia cepacia % Acceptable Enterococcus sp % Acceptable Enterococcus (Strep) faecalis % Acceptable Burkholderia sp % Acceptable Organisms present in specimen BA-2: Burkholderia cepacia and Enterococcus (Strep) faecalis. Specimen BA-3 Wound Culture Staphylococcus aureus % Acceptable Pasteurella multocida % Acceptable Pasteurella sp % Acceptable Organisms present in specimen BA-3: Staphylococcus aureus and Pasteurella multocida. 8 / 2016 MLE-M1 Participant Summary
9 METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS SCREEN Specimen MSA-1 Negative 5 100% Acceptable Organisms present in specimen MSA-1: Streptococcus pyogenes 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 Streptococcus sanguinis. Specimen MSA-4 Positive 5 100% Acceptable Organisms present in specimen MSA-4: Staphylococcus aureus Methicillin resistant and Neisseria sicca. Specimen MSA-5 Positive 5 100% Acceptable Organisms present in specimen MSA-5: Staphylococcus aureus Methicillin resistant and Pseudomonas aeruginosa MLE-M1 Participant Summary/ 9
10 URINE CULTURE Specimen UC-1 Escherichia coli % Acceptable Growth, referred for identification % Acceptable Gram negative bacilli % Acceptable Presump. Escherichia coli % Acceptable Presump. Gram negative % Acceptable Gram Stain Gram negative % Acceptable Gram positive % Gram Stain Morphology Rods/bacilli % Acceptable Diplococci % Organism present in specimen UC-1: Escherichia coli. Specimen UC-2 Staphylococcus aureus % Acceptable Growth, referred for identification % Acceptable Gram positive cocci % Acceptable Staphylococcus sp % Acceptable Presump. Staphylococcus sp % Acceptable Enterococcus sp % Acceptable Presump. Gram positive % Acceptable Organisms present in specimen UC-2: Staphylococcus aureus and Lactobacillus sp. Specimen UC-3 No growth (sterile) % Acceptable Organism present in specimen UC-3: No organism present. 10 / 2016 MLE-M1 Participant Summary
11 URINE CULTURE Specimen UC-4 Enterobacter cloacae % Acceptable Presump. Gram negative % Acceptable Growth, referred for identification % Acceptable Enterobacter sp % Acceptable Corynebacterium sp % Acceptable Gram negative bacilli % Acceptable Organisms present in specimen UC-4: Enterobacter cloacae and Corynebacterium sp. Specimen UC-5 Streptococcus agalactiae % Acceptable Growth, referred for identification % Acceptable Presump. Gram positive % Acceptable Gram positive cocci % Acceptable Presump. Streptococcus sp % Acceptable Strep beta hemo, not Grp A % Acceptable Organism present in specimen UC-5: Streptococcus agalactiae MLE-M1 Participant Summary/ 11
12 ANTIMICROBIAL SUSCEPTIBILIY TESTING Specimen UC-1, CC-1 (SUS-1) The organism present is: Escherichia coli Disk Diffusion MIC Interpretative category data Interpretative category data Antimicrobial Labs S I R Labs S I R Acceptable (%) Amikacin % Amoxicillin/Clavulanate % 1 Ampicillin % Ampicillin/Sulbactam % Carbenicillin Inappropriate drug 2 Cefamandole % Cefazolin % Cefepime % Cefixime % Cefoxitin % Cefpodoxime % Ceftazidime % Ceftriaxone % Cefuroxime % Cephalothin % Ciprofloxacin % Doxycycline % Ertapenem % Fosfomycin % Gentamicin % Imipenem % Levofloxacin % Meropenem % Nalidixic Acid % Nitrofurantoin % Norfloxacin % Piperacillin/Tazobactam % Sulfisoxazole % Tetracycline % Tobramycin % Trimethoprim % Trimethoprim/Sulfamethoxazole % NOTE: Please be aware that CLSI issues annual editions of M100, the supplement to the standards used by all proficiency testing programs for grading of susceptibilities. MLE has observed significant changes to which drugs are considered appropriate for various organisms with subsequent supplement editions. The current CLSI M100 document is accessible online at CLSI.org/m This antibiotic is graded by 90% referee consensus. 2 This is an inappropriate drug for organism and/or source. 12 / 2016 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 Coccobacilli % Organism present in specimen GC-1: Neisseria gonorrhoeae. Specimen GC-2 Negative for N gonorrhoeae % Acceptable Organisms present in specimen GC-2: Staphylococcus epidermidis and Corynebacterium sp. Specimen GC-3 Presumptive for N. gonorrhea % Acceptable Neisseria gonorrhoeae % Acceptable Organisms present in specimen GC-3: Neisseria gonorrhoeae and Lactobacillus casei MLE-M1 Participant Summary/ 13
14 GENITAL CULTURE Specimen GC-4 Negative for N. gonorrhoeae % Acceptable Organism present in specimen GC-4: Enterococcus faecalis. Specimen GC-5 Negative for N. gonorrhoeae % Acceptable Organism present in specimen GC-5: Escherichia coli. 14 / 2016 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 Calibrated Loop HealthLink Uri-Check Uricult Identification Specimen CC-1 Growth, referred for identification % Acceptable Presump. Escherichia coli % Acceptable Presump. Gram negative % Acceptable Escherichia coli % Acceptable Organism present in specimen CC-1: 50,000 75,000 CFU/mL of Escherichia coli. The colony count was graded by 80% referee consensus. 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 Calibrated Loop HealthLink Uri-Check Uricult Identification Specimen CC-2 Presump. Gram positive % Acceptable Growth, referred for identification % Acceptable Presump. Staphylococcus sp % Acceptable Staphylococcus aureus % Acceptable Organisms present in specimen CC-2: >100,000 CFU/mL of Staphylococcus aureus and <10,000 CFU/mL of Lactobacillus species MLE-M1 Participant Summary/ 15
16 COLONY COUNT/PRESUMPTIVE IDENTIFICATION Identification Specimen CC-3 No growth (sterile) % Acceptable Organism present in specimen CC-3: No organisms present. This challenge is graded by 80% referee consensus. Identification Specimen CC-4 Presump. Gram negative % Acceptable Growth, referred for identification % Acceptable Presump. Enterobacter sp % Acceptable Presump. Gram positive % Acceptable Enterobacter cloacae % Acceptable Gram negative bacilli % Acceptable Organisms present in specimen CC-4: >100,000 CFU/mL of Enterobacter cloacae and <10,000 CFU/mL of Corynebacterium sp. Identification Specimen CC-5 Growth, referred for identification % Acceptable Presump. Gram positive % Acceptable Presump. Streptococcus sp % Acceptable Streptococcus agalactiae % Acceptable Organism present in specimen CC-5: 50,000 75,000 CFU/mL of Staphylococcus aureus. 16 / 2016 MLE-M1 Participant Summary
17 DERMATOPHYTE SCREEN Specimen DM-1 Dermatophyte absent % Acceptable Dermatophyte present % Organism present in specimen DM-1: Pseudomonas aeruginosa. This challenge is graded by 80% referee consensus. Specimen DM-2 Dermatophyte present % Acceptable Organism present in specimen DM-2: Trichophyton rubrum. GRAM STAIN Specimen GS-1 Reaction Labs Percent Performance Gram negative % Acceptable Gram positive % Gram Stain Morphology Diplococci % Acceptable Cocci % Organism present in specimen GS-1: Neisseria gonorrhoeae. Specimen GS-2 Reaction Labs Percent Performance Gram negative % Acceptable Gram Stain Morphology Rods/bacilli % Acceptable Cocci % Coccobacilli % Organism present in specimen GS-2: Escherichia coli MLE-M1 Participant Summary/ 17
18 GRAM STAIN Specimen GS-3 Reaction Labs Percent Performance Gram positive % Acceptable Gram Stain Morphology Cocci % Acceptable Diplococci % Rods/bacilli % Organism present in specimen GS-3: Streptococcus pneumoniae. Specimen GS-4 Reaction Labs Percent Performance Gram negative % Acceptable Gram positive % Gram Stain Morphology Rods/bacilli % Acceptable Coccobacilli % Organism present in specimen GS-4: Pseudomonas aeruginosa. Specimen GS-5 Reaction Labs Percent Performance Gram positive % Acceptable Gram negative % Gram Stain Morphology Cocci % Acceptable Diplococci % Coccobacilli % Organism present in specimen GS-5: Staphylococcus aureus. 18 / 2016 MLE-M1 Participant Summary
19 AFFIRM VP III Trichomonas vaginalis Specimen VP-1 Negative % Acceptable Organism present in specimen VP-1: Escherichia coli. Specimen VP-2 Negative % Acceptable Organism present in specimen VP-2: Candida species. Specimen VP-3 Negative % Acceptable Organisms present in specimen VP-3: Candida species and Gardnerella vaginalis. Specimen VP-4 Positive % Acceptable Organism present in specimen VP-4: Trichomonas vaginalis. Specimen VP-5 Negative % Acceptable Organism present in specimen VP-5: Gardnerella vaginalis MLE-M1 Participant Summary/ 19
20 AFFIRM VP III Gardnerella vaginalis Specimen VP-1 Negative % Acceptable Specimen VP-2 Negative % Acceptable Specimen VP-3 Positive % Acceptable Specimen VP-4 Negative % Acceptable Specimen VP-5 Positive % Acceptable AFFIRM VP III Candida sp. Specimen VP-1 Negative % Acceptable Positive % Specimen VP-2 Positive % Acceptable Negative % 20 / 2016 MLE-M1 Participant Summary
21 AFFIRM VP III Candida sp. Specimen VP-3 Positive % Acceptable Negative % Specimen VP-4 Negative % Acceptable Specimen VP-5 Negative % Acceptable CHLAMYDIA (ANTIGEN DETECTION) Specimen CY-1 ALL METHODS BD ProbeTec 3-3 BD Viper 1-1 Cepheid GeneXpert Gen-Probe APTIMA Quidel QuickVue 6-6 Roche COBAS Amplicor 3-3 Organism present in specimen CY-1: Neisseria gonorrhoeae. Specimen CY-2 ALL METHODS BD ProbeTec BD Viper Cepheid GeneXpert Gen-Probe APTIMA Quidel QuickVue Roche COBAS Amplicor Organisms present in specimen CY-2: Chlamydia trachomatis MLE-M1 Participant Summary/ 21
22 CHLAMYDIA (ANTIGEN DETECTION) Specimen CY-3 ALL METHODS BD ProbeTec 3-3 BD Viper 1-1 Cepheid GeneXpert Gen-Probe APTIMA 2-2 Quidel QuickVue 4-4 Roche COBAS Amplicor 3-3 Organism present in specimen CY-3: No organisms present. Specimen CY-4 ALL METHODS BD ProbeTec BD Viper Cepheid GeneXpert Gen-Probe APTIMA Quidel QuickVue Roche COBAS Amplicor Organism present in specimen CY-4: Chlamydia trachomatis. Specimen CY-5 ALL METHODS BD ProbeTec BD Viper Cepheid GeneXpert Gen-Probe APTIMA Quidel QuickVue Roche COBAS Amplicor Organisms present in specimen CY-5: Neisseria gonorrhoeae and Chlamydia trachomatis. 22 / 2016 MLE-M1 Participant Summary
23 GC (ANTIGEN DETECTION) Specimen CY-1 ALL METHODS BD ProbeTec BD Viper Cepheid GeneXpert Gen-Probe APTIMA Roche COBAS Amplicor Specimen CY-2 ALL METHODS BD ProbeTec 3-3 BD Viper 1-1 Cepheid GeneXpert 2-2 Gen-Probe APTIMA 2-2 Roche COBAS Amplicor Specimen CY-3 ALL METHODS BD ProbeTec 3-3 BD Viper 1-1 Cepheid GeneXpert 2-2 Gen-Probe APTIMA 2-2 Roche COBAS Amplicor 3-3 Specimen CY-4 ALL METHODS BD ProbeTec 3-3 BD Viper 1-1 Cepheid GeneXpert 2-2 Gen-Probe APTIMA 2-2 Roche COBAS Amplicor 3-3 Specimen CY-5 ALL METHODS BD ProbeTec BD Viper Cepheid GeneXpert Gen-Probe APTIMA Roche COBAS Amplicor MLE-M1 Participant Summary/ 23
24 CRYPTOSPORIDIUM ANTIGEN DETECTION Specimen LC-1 ALL METHODS Alere CRYPTOSPORIDIUM II Alere Giardia/Crypto Quik Chek Antigen present in specimen LC-1: Cryptosporidium. Specimen LC-2 ALL METHODS 2-2 Alere CRYPTOSPORIDIUM II 1-1 Alere Giardia/Crypto Quik Chek 1-1 Antigen present in specimen LC-2: Giardia lamblia. Specimen LC-3 ALL METHODS Alere CRYPTOSPORIDIUM II Alere Giardia/Crypto Quik Chek Antigens present in specimen LC-3: Cryptosporidium and Giardia lamblia. Specimen LC-4 ALL METHODS 2-2 Alere CRYPTOSPORIDIUM II 1-1 Alere Giardia/Crypto Quik Chek 1-1 Antigen present in specimen LC-4: Giardia lamblia. Specimen LC-5 ALL METHODS 2-2 Alere CRYPTOSPORIDIUM II 1-1 Alere Giardia/Crypto Quik Chek 1-1 Antigen present in specimen LC-5: No antigens present. 24 / 2016 MLE-M1 Participant Summary
25 GIARDIA LAMBLIA ANTIGEN DETECTION Specimen LC-1 ALL METHODS 2-2 Alere GIARDIA II 1-1 Alere Giardia/Crypto Quik Chek 1-1 Specimen LC-2 ALL METHODS Alere GIARDIA II Alere Giardia/Crypto Quik Chek Specimen LC-3 ALL METHODS Alere GIARDIA II Alere Giardia/Crypto Quik Chek Specimen LC-4 ALL METHODS Alere GIARDIA II Alere Giardia/Crypto Quik Chek Specimen LC-5 ALL METHODS 2-2 Alere GIARDIA II 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 BD Directigen EZ BD Veritor - waived Quidel QuickVue RSV - waived Quidel Sofia - waived Antigen present in specimen V-1: RSV. Specimen V-2 ALL METHODS Alere Binax NOW - waived Alere Clearview RSV - waived BD Directigen EZ 1-1 BD Veritor - waived 1-1 Quidel QuickVue RSV - waived Quidel Sofia - waived 8-8 Antigen present in specimen V-2: Influenza B. Specimen V-3 ALL METHODS Alere Binax NOW - waived Quidel QuickVue RSV - waived Quidel Sofia - waived Antigen present in specimen V-3: RSV. Specimen V-4 ALL METHODS Alere Binax NOW - waived 5-5 Quidel QuickVue RSV - waived 4-4 Quidel Sofia - waived 4-4 Antigen present in specimen V-4: Influenza A. 26 / 2016 MLE-M1 Participant Summary
27 RSV ANTIGEN DETECTION Specimen V-5 ALL METHODS Alere Binax NOW - waived 5-5 Quidel QuickVue RSV - waived 4-4 Quidel Sofia - waived 4-4 Antigen present in specimen V-5: Influenza A. INFLUENZA A/B ANTIGEN DETECTION Specimen V-1 ALL METHODS Quidel QuickVue Influenza Antigen present in specimen V-1: RSV. Specimen V-2 ALL METHODS Quidel QuickVue Influenza 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: Influenza A. INFLUENZA A ANTIGEN DETECTION Specimen V-1 ALL METHODS Alere Binax NOW - waived Alere i Instrument Influenza 6-6 Alere Influenza A&B BD QTest 1-1 BD Veritor 1-1 BD Veritor - waived Cepheid GeneXpert 1-1 Henry Schein OneStep+ Flu A&B 3-3 Medline Influenza A&B 2-2 Quidel QuickVue Influenza A+B Quidel Sofia - waived Sekisui OSOM Influenza A&B Antigen present in specimen V-1: RSV. Specimen V-2 ALL METHODS Alere Binax NOW - waived Alere i Instrument Influenza 6-6 Alere Influenza A&B BD QTest 1-1 BD Veritor 1-1 BD Veritor - waived Cepheid GeneXpert 1-1 Henry Schein OneStep+ Flu A&B 3-3 Medline Influenza A&B 2-2 Quidel QuickVue Influenza A+B Quidel Sofia - waived Sekisui OSOM Influenza A&B Antigen present in specimen V-2: Influenza B. 28 / 2016 MLE-M1 Participant Summary
29 INFLUENZA A ANTIGEN DETECTION Specimen V-3 ALL METHODS Alere Binax NOW - waived Alere Influenza A&B 3-3 BD Veritor 1-1 BD Veritor - waived 5-5 Cepheid GeneXpert 1-1 Quidel QuickVue Influenza A+B 3-3 Quidel Sofia - waived Sekisui OSOM Influenza A&B Antigen present in specimen V-3: RSV. Specimen V-4 ALL METHODS Alere Binax NOW - waived Alere Influenza A&B BD Veritor BD Veritor - waived Cepheid GeneXpert Quidel QuickVue Influenza A+B Quidel Sofia - waived Sekisui OSOM Influenza A&B Antigen present in specimen V-4: Influenza A. Specimen V-5 ALL METHODS Alere Binax NOW - waived Alere Influenza A&B BD Veritor BD Veritor - waived Henry Schein OneStep+ Flu A&B Quidel QuickVue Influenza A+B Quidel Sofia - waived Sekisui OSOM Influenza A&B Antigen present in specimen V-5: Influenza A MLE-M1 Participant Summary/ 29
30 INFLUENZA B ANTIGEN DETECTION Specimen V-1 ALL METHODS Alere Binax NOW - waived Alere i Instrument Influenza 5-5 Alere Influenza A&B BD Veritor 1-1 BD Veritor - waived Cepheid GeneXpert 1-1 Henry Schein OneStep+ Flu A&B 3-3 Medline Influenza A&B 3-3 Quidel QuickVue Influenza A+B Quidel Sofia - waived Sekisui OSOM Influenza A&B Antigen present in specimen V-1: RSV. Specimen V-2 ALL METHODS Alere Binax NOW - waived Alere i Instrument Influenza Alere Influenza A&B BD Veritor BD Veritor - waived Cepheid GeneXpert Henry Schein OneStep+ Flu A&B Medline Influenza A&B Quidel QuickVue Influenza A+B Quidel Sofia - waived Sekisui OSOM Influenza A&B Antigen present in specimen V-2: Influenza B. 30 / 2016 MLE-M1 Participant Summary
31 INFLUENZA B ANTIGEN DETECTION Specimen V-3 ALL METHODS Alere Binax NOW - waived Alere Influenza A&B 3-3 BD Veritor 1-1 BD Veritor - waived 5-5 Cepheid GeneXpert 1-1 Quidel QuickVue Influenza A+B 3-3 Quidel Sofia - waived Sekisui OSOM Influenza A&B Antigen present in specimen V-3: RSV. Specimen V-4 ALL METHODS Alere Binax NOW - waived Alere Influenza A&B 3-3 BD Veritor 1-1 BD Veritor - waived 5-5 Cepheid GeneXpert 1-1 Quidel QuickVue Influenza A+B 3-3 Quidel Sofia - waived Sekisui OSOM Influenza A&B Antigen present in specimen V-4: Influenza A. Specimen V-5 ALL METHODS Alere Binax NOW - waived Alere Influenza A&B 3-3 BD Veritor 1-1 BD Veritor - waived 5-5 Cepheid GeneXpert 1-1 Quidel QuickVue Influenza A+B 3-3 Quidel Sofia - waived Sekisui OSOM Influenza A&B Antigen present in specimen V-5: Influenza A MLE-M1 Participant Summary/ 31
32 LEGIONELLA ANTIGEN DETETION Specimen L-1 ALL METHODS Binax NOW Specimen L-1: Negative for Legionella antigen. Specimen L-2 ALL METHODS Binax NOW Specimen L-2: Positive for Legionella antigen. Specimen L-3 ALL METHODS Binax NOW Specimen L-3: Negative for Legionella antigen. Specimen L-4 ALL METHODS Binax NOW Specimen L-4: Negative for Legionella antigen. Specimen L-5 ALL METHODS Binax NOW Specimen L-5: Positive for Legionella antigen. 32 / 2016 MLE-M1 Participant Summary
33 CLOSTRIDIUM DIFFICILE TOXIN ANTIGEN DETECTION Specimen AG-1 ALL METHODS Alere C. diff Quik Chek Meridian Illumigene Antigen present in specimen AG-1: Clostridium difficile. Specimen AG-2 ALL METHODS Alere C. diff Quik Chek Meridian Illumigene Antigens present in specimen AG-2: Clostridium difficile and Rotavirus. Specimen AG-3 ALL METHODS Alere C. diff Quik Chek Meridian Illumigene Antigen present in specimen AG-3: Clostridium difficile. Specimen AG-4 ALL METHODS 7-7 Alere C. diff Quik Chek 6-6 Meridian Illumigene 1-1 Antigen present in specimen AG-4: No antigens present MLE-M1 Participant Summary/ 33
34 CLOSTRIDIUM DIFFICILE TOXIN ANTIGEN DETECTION Specimen AG-5 ALL METHODS 7-7 Alere C. diff Quik Chek 6-6 Meridian Illumigene 1-1 Antigen present in specimen AG-5: Rotavirus. ROTAVIRUS ANTIGEN DETECTION Specimen AG-1 ALL METHODS 5-5 Fisher HealthCare Sure-Vue 5-5 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 / 2016 MLE-M1 Participant Summary
35 ROTAVIRUS ANTIGEN DETECTION Specimen AG-5 ALL METHODS Fisher HealthCare Sure-Vue STREPTOCOCCUS PNEUMONIAE ANTIGEN Specimen SP-1 ALL METHODS Binax NOW Specimen SP-1: Positive for Streptococcus pneumoniae antigen. Specimen SP-2 ALL METHODS Binax NOW Specimen SP-2: Negative for Streptococcus pneumoniae antigen. This challenge is graded by 80% referee consensus. Specimen SP-3 ALL METHODS Binax NOW Specimen SP-3: Negative for Streptococcus pneumoniae antigen. This challenge is graded by 80% referee consensus. Specimen SP-4 ALL METHODS Binax NOW Specimen SP-4: Positive for Streptococcus pneumoniae antigen. Specimen SP-5 ALL METHODS Binax NOW Specimen SP-5: Positive for Streptococcus pneumoniae antigen MLE-M1 Participant Summary/ 35
36 PARASITOLOGY Specimen PA-1 No parasite seen 3 100% Acceptable Parasite present in specimen PA-1: No parasite seen. Specimen PA-2 Entamoeba histolytica 3 100% Acceptable Parasite present in specimen PA-2: Entamoeba histolytica. Specimen PA-3 Hookworm % Ungraded Entamoeba coli % Ungraded Strongyloides stercoralis larvae % Ungraded Parasite present in specimen PA-3: Hookworm. PA-3 is an ungraded challenge due to less than 80% participant consensus. Specimen PA-4 Taenia sp. eggs % Acceptable Giardia lamblia % Acceptable Parasites present in specimen PA-4: Taenia sp. eggs and Giardia lamblia. Specimen PA-5 Microfilaria, unsheathed, NOS % Ungraded Microfilaria-Mansonella perstans % Ungraded Microfilaria-Loa loa % Ungraded No parasite seen % Ungraded Parasite present in specimen PA-5: Microfilaria-Loa loa. PA-5 is an ungraded challenge due to less than 80% participant consensus. Medical Laboratory Evaluation 25 Massachusetts Ave NW Ste 700 Washington, DC Fax: / 2016 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
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