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 2017 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 Clostridium Difficile Toxin Antigen Detection Gram Stain Rotavirus Antigen Detection Colony Count/Presumptive ID Legionella 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 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 Neisseria sp % Acceptable Staph coagulase negative % Acceptable Staphylococcus epidermidis % Acceptable Normal flora % Acceptable Organism(s) present: Neisseria sicca and Staphylococcus epidermidis. Specimen TC-2 Positive for Group A Strep % Acceptable Presump. Pos. Group A Strep % Acceptable Streptococcus pyogenes % Acceptable Organism(s) present: Streptococcus pyogenes. Specimen TC-3 Positive for Group A Strep % Acceptable Presump. Pos. Group A Strep % Acceptable Organism(s) present: Streptococcus pyogenes. Specimen TC-4 Positive for Group A Strep % Acceptable Presump. Pos. Group A Strep % Acceptable Organism(s) present: Streptococcus pyogenes. Specimen TC-5 Negative for Group A Strep % Acceptable Organism(s) present: Moraxella catarrhalis and Staphylococcus aureus 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 i Instrument - 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 - moderate 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 McKesson Strep A Dipstick Medline Strep A Test Strip Moore Medical Strep A Rapid Test Other Waived Method Polymedco Poly Stat Strep A - 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 / 2017 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 9-9 Alere i Instrument - waived 4-4 Alere Signify Strep A Dipstick 3-3 BD Chek Strep A 2-2 BD Veritor - waived 8-8 Beckman Coulter ICON DS 6-6 Beckman Coulter ICON SC 1-1 Binax NOW Strep A 1-1 Cardinal Health Strep A - moderate 2-2 Cardinal Health Strep A - waived 6-6 Consult Diagnostic Strep A Dipstick - Waived Fisher HealthCare Sure-Vue - waived 1-1 Germaine Laboratories StrepAim 3-3 Henry Schein One Step 2-2 Henry Schein One Step+ - waived McKesson Strep A Dipstick Medline Strep A Test Strip 1-1 Moore Medical Strep A Rapid Test 1-1 Other Waived Method Polymedco Poly Stat Strep A - waived Quidel QuickVue Dipstick Strep Quidel QuickVue In-Line Quidel QuickVue Quidel Sofia - waived 1-1 Quidel Sofia Strep A - moderate 3-3 Quidel Sofia Strep A+ - waived 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 Alere Signify Strep A Dipstick BD Chek Strep A BD Veritor - waived Beckman Coulter ICON DS Binax NOW Strep A Cardinal Health 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 Strep A - moderate Quidel Sofia Strep A+ - waived Sekisui OSOM Sekisui OSOM Ultra Strep A / 2017 MLE-M1 Participant Summary
7 STREP A ANTIGEN DETECTION Specimen RS-4 ALL METHODS Alere Acceava Strep A Test 2-2 Alere Signify Strep A Dipstick 1-1 BD Chek Strep A 2-2 BD Veritor - waived 1-1 Beckman Coulter ICON DS 1-1 Binax NOW Strep A 1-1 Cardinal Health Strep A - moderate 1-1 Consult Diagnostic Strep A Dipstick - Waived Henry Schein One Step+ - waived 3-3 McKesson Strep A Dipstick 3-3 Other Waived Method 2-2 Quidel QuickVue Dipstick Strep 9-9 Quidel QuickVue In-Line Quidel QuickVue+ 6-6 Quidel Sofia Strep A - moderate 2-2 Quidel Sofia Strep A+ - waived 3-3 Sekisui OSOM 1-1 Sekisui OSOM Ultra Strep A 6-6 Specimen RS-5 ALL METHODS Alere Acceava Strep A Test Alere Signify Strep A Dipstick BD Chek Strep A BD Veritor - waived Beckman Coulter ICON DS Binax NOW Strep A Cardinal Health 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 Strep A - moderate Quidel Sofia Strep A+ - waived Sekisui OSOM Sekisui OSOM Ultra Strep A MLE-M1 Participant Summary/ 7
8 GENERAL BACTERIOLOGY Specimen BA-1 Blood Culture No growth (sterile) % Ungraded Anaerobic culture not performed % Organism(s) present: Fusobacterium necrophorum. This is an ungraded challenge due to lack of participant consensus. Since this is a Blood Culture, the specimen should be plated both aerobically and anaerobically. Specimen BA-2 Sputum Culture Streptococcus pneumoniae % Acceptable Staphylococcus epidermidis % Acceptable Streptococcus alpha-hemolytic % Acceptable Staph coagulase negative % Acceptable Staphylococcus sp % Acceptable Organism(s) present: Streptococcus pneumoniae and Staphylococcus epidermidis. Specimen BA-3 Wound Culture Aeromonas sp % Acceptable Aeromonas hydrophila % Acceptable Streptococcus alpha-hemolytic % Acceptable Streptococcus salivarius % Acceptable Anaerobic cultures not perform % Acceptable Growth, referred for identification % Acceptable Streptococcus sanguinis % Acceptable Organism(s) present: Aeromonas hydrophila and Streptococcus salivarius. 8 / 2017 MLE-M1 Participant Summary
9 METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS SCREEN Specimen MSA-1 Negative 7 100% Acceptable Organism(s) present: Staphylococcus aureus Methicillin susceptible and Staphylococcus epidermidis. Specimen MSA-2 Positive 7 100% Acceptable Organism(s) present: Staphylococcus aureus Methicillin resistant. Specimen MSA-3 Positive 7 100% Acceptable Organism(s) present: Staphylococcus aureus Methicillin resistant and Corynebacterium sp. Specimen MSA-4 Positive 7 100% Acceptable Organism(s) present: Staphylococcus aureus Methicillin resistant and Streptococcus viridans. Specimen MSA-5 Negative 7 100% Acceptable Organism(s) present: Neisseria sicca MLE-M1 Participant Summary/ 9
10 URINE CULTURE Specimen UC-1 Streptococcus agalactiae % Acceptable Growth, referred for identification % Acceptable Gram positive cocci % Acceptable Presump. Gram positive % Acceptable Strep beta hemo, not Grp A % Acceptable Presump. Streptococcus sp % Acceptable Gram Stain Gram positive % Acceptable Gram Stain Morphology Cocci % Acceptable Organism(s) present: Streptococcus agalactiae. Specimen UC-2 Citrobacter sp % Acceptable Citrobacter koseri % Acceptable Growth, referred for identification % Acceptable Gram negative bacilli % Acceptable Presump. Gram negative % Acceptable Organism(s) present: Citrobacter koseri and Lactobacillus sp. Specimen UC-3 Moraxella catarrhalis % Acceptable Growth, referred for identification % Acceptable Moraxella sp % Acceptable Gram negative diplococci % Acceptable Organism(s) present: Moraxella catarrhalis. Specimen UC-3 was graded by 85% referee consensus. 10 / 2017 MLE-M1 Participant Summary
11 URINE CULTURE Specimen UC-4 No growth (sterile) % Ungraded Growth, referred for identification % Gram positive bacilli % Organism(s) present: Lactobacillus sp. This is an ungraded challenge due to less than 80% referee consensus. Specimen UC-5 Enterococcus sp % Acceptable Enterococcus (Strep) faecalis % Acceptable Presump. Enterococcus sp % Acceptable Growth, referred for identification % Acceptable Corynebacterium sp % Acceptable Presump. Gram positive % Acceptable Gram positive cocci % Acceptable Gram positive bacilli % Acceptable Organism(s) present: Enterococcus (Strep) faecalis and Corynebacterium sp MLE-M1 Participant Summary/ 11
12 ANTIMICROBIAL SUSCEPTIBILIY TESTING Specimen UC-1, CC-1 (SUS-1) Organism(s) present: Streptococcus agalactiae Disk Diffusion MIC Interpretative category data Interpretative category data Antimicrobial Labs S I R Labs S I R Acceptable (%) Amoxicillin/Clavulanate Ungraded 1 Ampicillin % Cefotaxime Ungraded 1 Ceftriaxone % Cephalothin % Ciprofloxacin Inappropriate drug 2 Clindamycin Inappropriate drug 2 Daptomycin Ungraded 1 Erythromycin Inappropriate drug 2 Levofloxacin % Linezolid % Penicillin % Quinupristin/Dalfopristin Inappropriate drug 2 Tetracycline % Trimethoprim/Sulfamethoxazole Inappropriate drug 2 Vancomycin % 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 is an ungraded challenge due to lack of comparison group. 2 This is an inappropriate drug for organism and/or source. 12 / 2017 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(s) present: Neisseria gonorrhoeae. Specimen GC-2 Negative for N. gonorrhoeae % Acceptable Listeria monocytogenes % Acceptable Staphylococcus sp % Acceptable Organism(s) present: Listeria monocytogenes and Staphylococcus epidermidis. Specimen GC-3 Presumptive for N. gonorrhoeae % Acceptable Neisseria gonorrhoeae % Acceptable Organism(s) present: Neisseria gonorrhoeae. Specimen GC-4 Presumptive for N. gonorrhoeae % Acceptable Neisseria gonorrhoeae % Acceptable Organism(s) present: Neisseria gonorrhoeae and Streptococcus viridans. Specimen GC-5 Negative for N. gonorrhoeae % Acceptable Gram positive cocci % Acceptable Organism(s) present: Enterococcus faecalis MLE-M1 Participant Summary/ 13
14 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 Note: Uricult method was not graded due to lack of consensus. Identification Specimen CC-1 Growth, referred for identification % Acceptable Presump. Gram positive % Acceptable Presump. Streptococcus sp % Acceptable Streptococcus agalactiae % Acceptable Organism(s) present: 50,000 75,000 CFU/mL of Streptococcus agalactiae. 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 Growth, referred for identification % Acceptable Presump. Gram negative % Acceptable Citrobacter koseri % Acceptable Organism(s) present: >100,000 CFU/mL of Citrobacter koseri and <10,000 CFU/mL of Lactobacillus sp. 14 / 2017 MLE-M1 Participant Summary
15 COLONY COUNT/PRESUMPTIVE IDENTIFICATION Identification Specimen CC-3 Growth, referred for identification % Acceptable Presump. Pseudomonas sp % Acceptable Presump. Gram negative % Acceptable Pseudomonas aeruginosa % Acceptable Organism(s) present: 50,000 75,000 CFU/mL of Pseudomonas aeruginosa. Identification Specimen CC-4 No growth (sterile) % Acceptable Growth referred for identification % Acceptable Streptococcus pyogenes % Organism(s) present: >100,000 CFU/mL of Lactobacillus species. No growth was accepted because Lactobacillus did not grow on most media. This challenge was graded by participant consensus. Identification Specimen CC-5 Growth, referred for identification % Acceptable Presump. Gram positive % Acceptable Presump. Enterococcus sp % Acceptable Enterococcus (Strep) faecalis % Acceptable Organism(s) present: >100,000 CFU/mL of Enterococcus faecalis and 50,000 75,000 CFU/mL of Corynebacterium sp MLE-M1 Participant Summary/ 15
16 DERMATOPHYTE SCREEN Specimen DM-1 Dermatophyte absent % Acceptable Dermatophyte present % Organism(s) present: Staphylococcus epidermidis. Specimen DM-2 Dermatophyte present % Not graded Dermatophyte absent % Organism(s) present: Microsporum canis. Specimen DM-2 was ungraded due to lack of participant consensus. GRAM STAIN Specimen GS-1 Reaction Labs Percent Performance Gram positive % Acceptable Gram negative % Gram Stain Morphology Cocci % Acceptable Diplococci % Organism(s) present: Staphylococcus aureus. Specimen GS-2 Reaction Labs Percent Performance Gram positive % Acceptable Gram Stain Morphology Cocci % Acceptable Coccobacilli % Organism(s) present: Streptococcus pneumoniae 16 / 2017 MLE-M1 Participant Summary
17 GRAM STAIN Specimen GS-3 Reaction Labs Percent Performance Gram negative % Acceptable Gram positive % Gram Stain Morphology Diplococci % Acceptable Cocci % Acceptable Coccobacilli % Rods/bacilli % Organism(s) present: Neisseria mucosa. Specimen GS-4 Reaction Labs Percent Performance Gram negative % Acceptable Gram positive % Gram Stain Morphology Rods/bacilli % Acceptable Coccobacilli % Diplococci % Organism(s) present: Citrobacter freundii. Specimen GS-5 Reaction Labs Percent Performance Gram negative % Acceptable Gram positive % Gram Stain Morphology Rods/bacilli % Acceptable Coccobacilli % Organism(s) present: Pseudomonas aeruginosa MLE-M1 Participant Summary/ 17
18 AFFIRM VP III Trichomonas vaginalis Specimen VP-1 Negative % Acceptable Organism(s) present: Gardnerella vaginalis. Specimen VP-2 Positive % Acceptable Organism(s) present: Candida species and Trichomonas vaginalis Specimen VP-3 Negative % Acceptable Organism(s) present: Escherichia coli. Specimen VP-4 Negative % Acceptable Organism(s) present: Candida species. Specimen VP-5 Positive % Acceptable Organism(s) present: Trichomonas vaginalis 18 / 2017 MLE-M1 Participant Summary
19 AFFIRM VP III Gardnerella vaginalis Specimen VP-1 Positive % Acceptable Organism(s) present: Gardnerella vaginalis. Specimen VP-2 Negative % Acceptable Positive % Organism(s) present: Candida species and Trichomonas vaginalis Specimen VP-3 Negative % Acceptable Organism(s) present: Escherichia coli. Specimen VP-4 Negative % Acceptable Organism(s) present: Candida species. Specimen VP-5 Negative % Acceptable Positive % Organism(s) present: Trichomonas vaginalis. Specimen VP-5 was graded by 87% referee consensus MLE-M1 Participant Summary/ 19
20 AFFIRM VP III Candida sp. Specimen VP-1 Negative % Acceptable Organism(s) present: Gardnerella vaginalis. Specimen VP-2 Positive % Acceptable Negative % Organism(s) present: Candida species and Trichomonas vaginalis Specimen VP-3 Negative % Acceptable Organism(s) present: Escherichia coli. Specimen VP-4 Positive % Acceptable Negative % Organism(s) present: Candida species. Specimen VP-5 Negative % Acceptable Organism(s) present: Trichomonas vaginalis. 20 / 2017 MLE-M1 Participant Summary
21 CHLAMYDIA (ANTIGEN DETECTION) Specimen CY-1 ALL METHODS BD ProbeTec BD Viper Cepheid GeneXpert Gen-Probe APTIMA Quidel QuickVue Roche COBAS Amplicor Antigen(s) present: Chlamydia trachomatis. Specimen CY-2 ALL METHODS BD ProbeTec BD Viper Cepheid GeneXpert Gen-Probe APTIMA Quidel QuickVue Roche COBAS Amplicor Antigen(s) present: Chlamydia trachomatis and Neisseria gonorrhoeae. Specimen CY-3 ALL METHODS BD ProbeTec 3-3 BD Viper 1-1 Cepheid GeneXpert 2-2 Gen-Probe APTIMA 1-1 Quidel QuickVue 2-2 Roche COBAS Amplicor 2-2 Antigen(s) present: Neisseria gonorrhoeae. Specimen CY-4 ALL METHODS BD ProbeTec 3-3 BD Viper 1-1 Cepheid GeneXpert 2-2 Gen-Probe APTIMA 1-1 Quidel QuickVue 2-2 Roche COBAS Amplicor 2-2 Antigen(s) present: Neisseria gonorrhoeae MLE-M1 Participant Summary/ 21
22 CHLAMYDIA (ANTIGEN DETECTION) Specimen CY-5 ALL METHODS BD ProbeTec 3-3 BD Viper 1-1 Cepheid GeneXpert 2-2 Gen-Probe APTIMA 1-1 Quidel QuickVue 2-2 Roche COBAS Amplicor 2-2 Antigen(s) present: Neisseria gonorrhoeae. GC (ANTIGEN DETECTION) Specimen CY-1 ALL METHODS BD ProbeTec 3-3 BD Viper 1-1 Cepheid GeneXpert 2-2 Gen-Probe APTIMA 1-1 Roche COBAS Amplicor 2-2 Antigen(s) present: Chlamydia trachomatis. Specimen CY-2 ALL METHODS BD ProbeTec BD Viper Cepheid GeneXpert Gen-Probe APTIMA 1-1 Roche COBAS Amplicor Antigen(s) present: Chlamydia trachomatis and Neisseria gonorrhoeae. Specimen CY-3 ALL METHODS BD ProbeTec BD Viper Cepheid GeneXpert Gen-Probe APTIMA Roche COBAS Amplicor Antigen(s) present: Neisseria gonorrhoeae. 22 / 2017 MLE-M1 Participant Summary
23 GC (ANTIGEN DETECTION) Specimen CY-4 ALL METHODS BD ProbeTec BD Viper Cepheid GeneXpert Gen-Probe APTIMA 1-1 Roche COBAS Amplicor Antigen(s) present: Neisseria gonorrhoeae. Specimen CY-5 ALL METHODS BD ProbeTec BD Viper Cepheid GeneXpert Gen-Probe APTIMA 1-1 Roche COBAS Amplicor Antigen(s) present: Neisseria gonorrhoeae MLE-M1 Participant Summary/ 23
24 CRYPTOSPORIDIUM ANTIGEN DETECTION Specimen LC-1 ALL METHODS Alere CRYPTOSPORIDIUM II Antigen(s) present: Cryptosporidium and Giardia lamblia. Specimen LC-2 ALL METHODS 1-1 Alere CRYPTOSPORIDIUM II 1-1 Antigen(s) present: Giardia lamblia. Specimen LC-3 ALL METHODS Alere CRYPTOSPORIDIUM II Antigen(s) present: Cryptosporidium and Giardia lamblia. Specimen LC-4 ALL METHODS Alere CRYPTOSPORIDIUM II Antigen(s) present: Cryptosporidium. Specimen LC-5 ALL METHODS 1-1 Alere CRYPTOSPORIDIUM II 1-1 Antigen(s) present: No antigen present. 24 / 2017 MLE-M1 Participant Summary
25 GIARDIA LAMBLIA ANTIGEN DETECTION Specimen LC-1 ALL METHODS Alere GIARDIA II Antigen(s) present: Cryptosporidium and Giardia lamblia. Specimen LC-2 ALL METHODS Alere GIARDIA II Antigen(s) present: Giardia lamblia. Specimen LC-3 ALL METHODS Alere GIARDIA II Antigen(s) present: Cryptosporidium and Giardia lamblia. Specimen LC-4 ALL METHODS 1-1 Alere GIARDIA II 1-1 Antigen(s) present: Cryptosporidium. Specimen LC-5 ALL METHODS 1-1 Alere GIARDIA II 1-1 Antigen(s) present: No antigen present MLE-M1 Participant Summary/ 25
26 RSV ANTIGEN DETECTION Specimen V-1 ALL METHODS Alere Binax NOW - waived Alere Clearview RSV - waived BD Veritor - waived Quidel QuickVue RSV - waived Quidel QuickVue RSV 10 Test Quidel Sofia - waived Antigen(s) present: RSV. Specimen V-2 ALL METHODS Alere Binax NOW - waived Alere Clearview RSV - waived 5-5 BD Veritor - waived 1-1 Quidel QuickVue RSV - waived Quidel QuickVue RSV 10 Test 2-2 Quidel Sofia - waived Antigen(s) present: Influenza A. Specimen V-3 ALL METHODS Alere Binax NOW - waived 4-4 Quidel QuickVue RSV - waived 5-5 Quidel QuickVue RSV 10 Test 2-2 Quidel Sofia - waived 5-5 Antigen(s) present: Influenza B. Specimen V-4 ALL METHODS Alere Binax NOW - waived 4-4 Quidel QuickVue RSV - waived 5-5 Quidel QuickVue RSV 10 Test 2-2 Quidel Sofia - waived 5-5 Antigen(s) present: No antigen present. 26 / 2017 MLE-M1 Participant Summary
27 RSV ANTIGEN DETECTION Specimen V-5 ALL METHODS Alere Binax NOW - waived 4-4 Quidel QuickVue RSV - waived 5-5 Quidel QuickVue RSV 10 Test 2-2 Quidel Sofia - waived 5-5 Antigen(s) present: Influenza B. INFLUENZA A/B ANTIGEN DETECTION Specimen V-1 ALL METHODS BD Veritor - waived 3-3 Quidel QuickVue Influenza Antigen(s) present: RSV. Specimen V-2 ALL METHODS Alere Binax NOW - waived Other Waived Method Quidel QuickVue Influenza Antigen(s) present: Influenza A. Specimen V-3 ALL METHODS Quidel QuickVue Influenza Antigen(s) present: Influenza B. Specimen V-4 ALL METHODS 9-9 Quidel QuickVue Influenza 9-9 Antigen(s) present: No antigen present MLE-M1 Participant Summary/ 27
28 INFLUENZA A/B ANTIGEN DETECTION Specimen V-5 ALL METHODS Quidel QuickVue Influenza Antigen(s) present: Influenza B. INFLUENZA A ANTIGEN DETECTION Specimen V-1 ALL METHODS Alere Binax NOW - waived Alere i Instrument - moderate 8-8 Alere Influenza A&B BD Veritor - waived Henry Schein OneStep+ Flu A&B 8-8 Medline Influenza A&B 3-3 Other Waived Method 1-1 Quidel QuickVue Influenza 3-3 Quidel QuickVue Influenza A+B Quidel Sofia - waived Sekisui OSOM Influenza A&B 7-7 Antigen(s) present: RSV. Specimen V-2 ALL METHODS Alere Binax NOW - waived Alere i Instrument - moderate Alere Influenza A&B BD Veritor - waived Henry Schein OneStep+ Flu A&B Medline Influenza A&B Other Waived Method Quidel QuickVue Influenza Quidel QuickVue Influenza A+B Quidel Sofia - waived Sekisui OSOM Influenza A&B Antigen(s) present: Influenza A. 28 / 2017 MLE-M1 Participant Summary
29 INFLUENZA A ANTIGEN DETECTION Specimen V-3 ALL METHODS Alere Binax NOW - waived 7-7 Alere Influenza A&B 3-3 BD Veritor - waived 2-2 Henry Schein OneStep+ Flu A&B 1-1 Quidel QuickVue Influenza A+B 4-4 Quidel Sofia - waived Sekisui OSOM Influenza A&B 4-4 Antigen(s) present: Influenza B. Specimen V-4 ALL METHODS Alere Binax NOW - waived 7-7 Alere Influenza A&B 3-3 BD Veritor - waived 2-2 Henry Schein OneStep+ Flu A&B 1-1 Quidel QuickVue Influenza A+B 4-4 Quidel Sofia - waived Sekisui OSOM Influenza A&B 4-4 Antigen(s) present: No antigen present. Specimen V-5 ALL METHODS Alere Binax NOW - waived 7-7 Alere Influenza A&B 3-3 BD Veritor - waived 2-2 Henry Schein OneStep+ Flu A&B 1-1 Quidel QuickVue Influenza A+B 4-4 Quidel Sofia - waived Sekisui OSOM Influenza A&B 4-4 Antigen(s) present: Influenza B MLE-M1 Participant Summary/ 29
30 INFLUENZA B ANTIGEN DETECTION Specimen V-1 ALL METHODS Alere Binax NOW - waived Alere i Instrument - moderate 8-8 Alere Influenza A&B BD Veritor - waived Henry Schein OneStep+ Flu A&B 8-8 Medline Influenza A&B 3-3 Other Waived Method 1-1 Quidel QuickVue Influenza 3-3 Quidel QuickVue Influenza A+B Quidel Sofia - waived Sekisui OSOM Influenza A&B Antigen(s) present: RSV. Specimen V-2 ALL METHODS Alere Binax NOW - waived Alere i Instrument - moderate 8-8 Alere Influenza A&B BD Veritor - waived Henry Schein OneStep+ Flu A&B Medline Influenza A&B 3-3 Other Waived Method 1-1 Quidel QuickVue Influenza 3-3 Quidel QuickVue Influenza A+B Quidel Sofia - waived Sekisui OSOM Influenza A&B 7-7 Antigen(s) present: Influenza B. 30 / 2017 MLE-M1 Participant Summary
31 INFLUENZA B ANTIGEN DETECTION Specimen V-3 ALL METHODS Alere Binax NOW - waived Alere Influenza A&B BD Veritor - waived Henry Schein OneStep+ Flu A&B Quidel QuickVue Influenza A+B Quidel Sofia - waived Sekisui OSOM Influenza A&B Antigen(s) present: Influenza B. Specimen V-4 ALL METHODS Alere Binax NOW - waived 7-7 Alere Influenza A&B 3-3 BD Veritor - waived 2-2 Henry Schein OneStep+ Flu A&B Quidel QuickVue Influenza A+B 4-4 Quidel Sofia - waived Sekisui OSOM Influenza A&B 4-4 Antigen(s) present: No antigen present. Specimen V-5 ALL METHODS Alere Binax NOW - waived Alere Influenza A&B BD Veritor - waived Henry Schein OneStep+ Flu A&B 1-1 Quidel QuickVue Influenza A+B Quidel Sofia - waived Sekisui OSOM Influenza A&B Antigen(s) present: Influenza B MLE-M1 Participant Summary/ 31
32 CLOSTRIDIUM DIFFICILE TOXIN ANTIGEN DETECTION Specimen AG-1 ALL METHODS Alere C. diff Quik Chek Antigen(s) present: Clostridium difficile and Rotavirus. Specimen AG-2 ALL METHODS Alere C. diff Quik Chek Antigen(s) present: Clostridium difficile and Rotavirus. Specimen AG-3 ALL METHODS 6-6 Alere C. diff Quik Chek 6-6 Antigen(s) present: Rotavirus. Specimen AG-4 ALL METHODS Alere C. diff Quik Chek Antigen(s) present: Clostridium difficile and Rotavirus. Specimen AG-5 ALL METHODS 6-6 Alere C. diff Quik Chek 6-6 Antigen(s) present: No antigen present. 32 / 2017 MLE-M1 Participant Summary
33 ROTAVIRUS ANTIGEN DETECTION Specimen AG-1 ALL METHODS Fisher HealthCare Sure-Vue Antigen(s) present: Clostridium difficile and Rotavirus. Specimen AG-2 ALL METHODS Fisher HealthCare Sure-Vue Antigen(s) present: Clostridium difficile and Rotavirus. Specimen AG-3 ALL METHODS Fisher HealthCare Sure-Vue Antigen(s) present: Rotavirus. Specimen AG-4 ALL METHODS Fisher HealthCare Sure-Vue Antigen(s) present: Clostridium difficile and Rotavirus. Specimen AG-5 ALL METHODS 5-5 Fisher HealthCare Sure-Vue 5-5 Antigen(s) present: No antigen present MLE-M1 Participant Summary/ 33
34 LEGIONELLA ANTIGEN DETETION Specimen L-1 Binax NOW Specimen L-2 Binax NOW Specimen L-3 Binax NOW Specimen L-4 Binax NOW Specimen L-5 Binax NOW / 2017 MLE-M1 Participant Summary
35 STREPTOCOCCUS PNEUMONIAE ANTIGEN Specimen SP-1 Binax NOW Specimen SP-2 Binax NOW Specimen SP-3 Binax NOW Specimen SP-4 Binax NOW Specimen SP-5 Binax NOW MLE-M1 Participant Summary/ 35
36 PARASITOLOGY Specimen PA-1 Giardia lamblia 1 100% Acceptable Parasite(s) present: Giardia lamblia. Specimen PA-2 Dientamoeba fragilis 1 100% Acceptable Parasite(s) present: Dientamoeba fragilis. Specimen PA-3 No parasite seen 1 100% Acceptable Parasite(s) present: Pollen artifact. Specimen PA-4 Clonorchis sinensis 1 100% Acceptable Parasite(s) present: Clonorchis sinensis. Specimen PA-5 Plasmodium malariae 1 100% Ungraded Parasite(s) present: Plasmodium falciparum. This is an ungraded challenge due to less than 80% participant consensus. Medical Laboratory Evaluation 25 Massachusetts Ave NW Ste 700 Washington, DC Fax: / 2017 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 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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