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-M2 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-6 Negative for Group A Strep % Acceptable Staphylococcus aureus % Acceptable Staphylococcus sp % Acceptable Organism present in specimen TC-6: Staphylococcus aureus. Specimen TC-7 Positive for Group A Strep % Acceptable Presump. Pos. Group A Strep % Acceptable Streptococcus pyogenes % Acceptable Organism present in specimen TC-7: Streptococcus pyogenes. Specimen TC-8 Negative for Group A Strep % Acceptable Organisms present in specimen TC-8: Moraxella catarrhalis and Staphylococcus epidermidis. Specimen TC-9 Negative for Group A Strep % Acceptable Organism present in specimen TC-9: Neisseria mucosa. Specimen TC-10 Positive for Group A Strep % Acceptable Presump. Pos. Group A Strep % Acceptable Organism present in specimen TC-10: Streptococcus pyogenes and Staphylococcus epidermidis MLE-M2 Participant Summary/ 3
4 STREP A ANTIGEN DETECTION Specimen RS-6 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 Dipstick - Waived Fisher HealthCare Sure-Vue Fisher HealthCare Sure-Vue - waived Henry Schein One Step+ - waived Immunostics Detector Strep A Direct McKesson Strep A Dipstick 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 Strep A - moderate Quidel Sofia Strep A+ - waived Sekisui OSOM Sekisui OSOM Ultra Strep A / 2015 MLE-M2 Participant Summary
5 STREP A ANTIGEN DETECTION Specimen RS-7 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 3-3 BD Veritor - waived 2-2 Beckman Coulter ICON DS 2-2 Beckman Coulter ICON SC 3-3 Binax NOW Strep A 7-7 Cardinal Health Strep A - waived Consult Diagnostic Strep A Dipstick - Waived Fisher HealthCare Sure-Vue 1-1 Fisher HealthCare Sure-Vue - waived 1-1 Henry Schein One Step+ - waived Immunostics Detector Strep A Direct 7-7 McKesson Strep A Dipstick 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 3-3 Quidel QuickVue Dipstick Strep Quidel QuickVue In-Line Quidel QuickVue Quidel Sofia Strep A - moderate 6-6 Sekisui OSOM Sekisui OSOM Ultra Strep A MLE-M2 Participant Summary/ 5
6 STREP A ANTIGEN DETECTION Specimen RS-8 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 Binax NOW Strep A 1-1 Cardinal Health Strep A - waived 1-1 Consult Diagnostic Strep A Dipstick - Waived 2-2 Henry Schein One Step+ - waived 1-1 McKesson Strep A Dipstick 6-6 Other Waived Method 6-6 Polymedco Poly Stat Strep A - moderate PSS Select Diag. Strep A Dipstick - waived 2-2 Quidel QuickVue Dipstick Strep 1-1 Quidel QuickVue In-Line Quidel QuickVue Quidel Sofia Strep A - moderate Sekisui OSOM 4-4 Sekisui OSOM Ultra Strep A / 2015 MLE-M2 Participant Summary
7 STREP A ANTIGEN DETECTION Specimen RS-9 ALL METHODS Alere Acceava Strep A Test 2-2 BD Chek Strep A 1-1 BD Veritor - waived 1-1 Beckman Coulter ICON DS 1-1 Binax NOW Strep A 1-1 Cardinal Health Strep A - waived 1-1 Consult Diagnostic Strep A Dipstick - Waived Henry Schein One Step+ - waived 6-6 McKesson Strep A Dipstick 4-4 Other Waived Method 2-2 PSS Select Diag. Strep A Dipstick - waived 1-1 Quidel QuickVue Dipstick Strep Quidel QuickVue In-Line Quidel QuickVue Quidel Sofia Strep A - moderate 5-5 Sekisui OSOM 2-2 Sekisui OSOM Ultra Strep A 7-7 Specimen RS-10 ALL METHODS Alere Acceava Strep A Test BD Chek Strep A BD Veritor - waived Beckman Coulter ICON DS Binax NOW Strep A Cardinal Health Strep A - waived 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 Sekisui OSOM Sekisui OSOM Ultra Strep A MLE-M2 Participant Summary/ 7
8 GENERAL BACTERIOLOGY Specimen BA-4 Spinal Fluid Culture Listeria monocytogenes % Acceptable Organism present in specimen BA-4: Listeria monocytogenes. Specimen BA-5 Respiratory Culture Haemophilus influenzae % Acceptable Corynebacterium species % Acceptable Organisms present in specimen BA-5: Haemophilus influenzae and Corynebacterium species. Specimen BA-6 Wound Culture Pseudomonas aeruginosa % Acceptable Staph coagulase negative % Acceptable Staphylococcus species % Acceptable Staphylococcus epidermidis % Acceptable Organisms present in specimen BA-6: Pseudomonas aeruginosa and Staphylococcus epidermidis. 8 / 2015 MLE-M2 Participant Summary
9 METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS SCREEN Specimen MSA-6 Positive 2 100% Acceptable Organisms present in specimen MSA-6 Staphylococcus aureus Methicillin resistant and Pseudomonas aeruginosa. Specimen MSA-7 Negative 2 100% Acceptable Organism present in specimen MSA-7: Staphylococcus aureus Methicillin resistant. Specimen MSA-8 Negative 2 100% Acceptable Organisms present in specimen MSA-8: Klebsielle pneumoniae and Staphylococcus epidermidis. Specimen MSA-9 Negative 2 100% Acceptable Organisms present in specimen MSA-9: Corynebacterium species and Neisseria meningitidis. Specimen MSA-10 Positive 2 100% Acceptable Organisms present in specimen MSA-10: Staphylococcus aureus Methicillin resistant and Streptococcus pyogenes MLE-M2 Participant Summary/ 9
10 URINE CULTURE Specimen UC-6 Citrobacter freundii % Acceptable Growth, referred for identification % Acceptable Citrobacter sp % Acceptable Gran negative bacilli % Acceptable Presump. Gram negative % Acceptable Gram Stain Gram negative % Acceptable Gram positive % Gram Stain Morphology Rods/bacilli % Acceptable Organism present in specimen UC-6: Citrobacter freundii. Specimen UC-7 Enterococcus sp % Acceptable Growth, referred for identification % Acceptable Gram positive cocci % Acceptable Enterococcus (Strep) faecalis % Acceptable Presump. Gram positive % Acceptable Presump. Enterococcus sp % Acceptable Organisms present in specimen UC-7: Enterococcus (Strep) faecalis and Lactobacillus species. Specimen UC-8 No growth (sterile) % Acceptable Growth, referred for identification % Organism present in specimen UC-8: No growth (sterile). 10 / 2015 MLE-M2 Participant Summary
11 URINE CULTURE Specimen UC-9 Klebsiella pneumoniae % Acceptable Growth, referred for identification % Acceptable Presump. Gram negative % Acceptable Gram negative bacilli % Acceptable Corynebacterium sp % Acceptable Klebsiella sp % Acceptable Organisms present in specimen UC-9: Klebsiella pneumoniae and Corynebacterium species. Specimen UC-10 Staphylococcus saprophyticus % Acceptable Growth, referred for identification % Acceptable Presump. Gram % Acceptable Gram positive cocci % Acceptable Staphylococcus sp % Acceptable Staph = coagulase negative % Acceptable Organism present in specimen UC-10: Staphylococcus saprophyticus MLE-M2 Participant Summary/ 11
12 ANTIMICROBIAL SUSCEPTIBILIY TESTING Specimen UC-6, CC-6 (SUS-6) The organism present is: Citrobacter freundii Disk Diffusion MIC Interpretative category data Interpretative category data Antimicrobial Labs S I R Labs S I R Acceptable (%) Amikacin Not graded 1 Amoxicillin/Clavulanate % Ampicillin % 2 Ampicillin/Sulbactam Not graded 1 Aztreonam Not graded 1 Carbenicillin Inappropriate drug 3 Cefamandole Not graded 1 Cefazolin % Cefepime % Cefixime % Cefotaxime Not graded 1 Cefoxitin % Cefpodoxime Not graded 1 Ceftazidime % Ceftriaxone % Cefuroxime Not graded 4 Cephalothin % Ciprofloxacin % Doxycycline Not graded 1 Ertapenem % Gentamicin % Imipenem % Levofloxacin % Meropenem Not graded 1 Nalidixic Acid Not graded 1 Nitrofurantoin % Norfloxacin % Piperacillin Not graded 1 Piperacillin/Tazobactam % Sulfisoxazole % Tetracycline % Tobramycin % Trimethoprim % Trimethoprim/Sulfamethoxazole % 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 specimen was graded by 90% referee consensus. 3 This is an inappropriate drug for organism and/or source. 4 Ungraded challenge due to less than 80% referee consensus. 12 / 2015 MLE-M2 Participant Summary
13 GENITAL CULTURE Specimen GC-6 Presumptive for N. gonorrhoeae % Acceptable Neisseria gonorrhoeae % Acceptable Growth, referred for identification % Acceptable Gram negative diplococci % Acceptable Gram Stain Gram negative % Acceptable Gram positive % Gram Stain Morphology Diplococci % Acceptable Cocci % Organism present in specimen GC-6: Neisseria gonorrhoeae. Specimen GC-7 Negative for N. gonorrhoeae % Acceptable Organisms present in specimen GC-7: Streptococcus agalactiae and Corynebacterium species. Specimen GC-8 Presumptive for N. gonorrhea % Acceptable Neisseria gonorrhoeae % Acceptable Organisms present in specimen GC-8: Neisseria gonorrhoeae and Lactobacillus species MLE-M2 Participant Summary/ 13
14 GENITAL CULTURE Specimen GC-9 Negative for N. gonorrhoeae % Acceptable Gram positive cocci % Acceptable Growth, referred for identification % Acceptable Organism present in specimen GC-9: Staphylococcus aureus. Specimen GC-10 Negative for N. gonorrhoeae % Acceptable Organism present in specimen GC-10: Escherichia coli. 14 / 2015 MLE-M2 Participant Summary
15 COLONY COUNT/PRESUMPTIVE IDENTIFICATION Specimen CC-6 Method Labs No growth <10,000 organisms/ml 10, ,000 organisms/ml >100,000 organisms/ml ALL METHODS Bulls Eye Calibrated Loop HealthLink Troy Bacti-Urine, Plate Uri-Check Uricult This specimen was graded by 87% referee consensus. Identification Specimen CC-6 Presump. Gram negative % Acceptable Growth, referred for identification % Acceptable Citrobacter freundii % Acceptable Gram negative bacilli % Acceptable Organism present in specimen CC-6: 10, ,000 CFU/mL of Citrobacter freundii. COLONY COUNT/PRESUMPTIVE IDENTIFICATION Specimen CC-7 Method Labs No growth <10,000 organisms/ml 10, ,000 organisms/ml >100,000 organisms/ml ALL METHODS Bulls Eye Calibrated Loop HealthLink Troy Bacti-Urine, Plate Uri-Check Uricult Identification Specimen CC-7 Presump. Gram positive % Acceptable Growth, referred for identification % Acceptable Presump. Enterococcus sp % Acceptable Enterococcus (Strep) faecalis % Acceptable Gram positive cocci % Acceptable Organisms present in specimen CC-7: >100,000 CFU/mL of Enterococcus (Strep) faecalis and <10,000 CFU/mL of Lactobacillus species MLE-M2 Participant Summary/ 15
16 COLONY COUNT/PRESUMPTIVE IDENTIFICATION Identification Specimen CC-8 No growth (sterile) % Acceptable Organism present in specimen CC-8: No growth (sterile). Identification Specimen CC-9 Presump. Gram negative % Acceptable Growth, referred for identification % Acceptable Presump. Klebsiella sp % Acceptable Klebsiella sp % Acceptable Klebsiella pneumoniae % Acceptable Organisms present in specimen CC-9: 10, ,000 CFU/mL of Klebsiella pneumoniae and <10,000 CFU/mL of Corynebacterium species. Identification Specimen CC-10 Presump. Gram positive % Acceptable Growth, referred for identification % Acceptable Presump. Staphylococcus sp % Acceptable Staph coagulase negative % Acceptable Staphylococcus saprophyticus % Acceptable Organism present in specimen CC-10: >100,000 CFU/mL of Staphylococcus saprophyticus. 16 / 2015 MLE-M2 Participant Summary
17 DERMATOPHYTE SCREEN Specimen DM-3 Dermatophyte present % Acceptable Organism present in specimen DM-3: Trichophyton rubrum. Specimen DM-4 Dermatophyte absent % Acceptable Dermatophyte present % Organism present in specimen DM-4: Candida albicans. This specimen was graded by 80% referee consensus. Dermatophytes are absent from this specimen. Dermatophytes are a specific group of fungi that commonly cause infections of the hair, skin and nails. These infections are most often caused by the genera Trichophyton, Microsporum, and Epidermophyton. Presumptive identification of dermatophytes using special media such as Dermatophyte Test Medium (DTM) is based on both gross morphology and color change. Dermatophytes produce typical morphology and a red color change in the medium around the colony within days of incubation. Yeasts and other non-dermatophyte fungi may grow on DTM. Candida species appear as small, dull (matte), white or cream color bacteria-like colonies on DTM agars. Some strains of yeast may produce a pink-red color change on DTM with prolonged incubation. Consult your manufacturer s package insert instructions for length of incubation, interpretation of results, and limitations of the test, to determine if the test was performed properly. Call the manufacturer for technical assistance if needed. Reference: Hardy Diagnostics Bacti-Lab Skin Culture Systems GRAM STAIN Specimen GS-6 Reaction Labs Percent Performance Gram positive % Acceptable Gram negative % Gram Stain Morphology Cocci % Acceptable Diplococci % Acceptable Coccobacilli % Organism present in specimen GS-6: Streptococcus agalactiae. Specimen GS-7 Reaction Labs Percent Performance Gram negative % Acceptable Gram Stain Morphology Rods/bacilli % Acceptable Organism present in specimen GS-7: Pseudomonas aeruginosa MLE-M2 Participant Summary/ 17
18 GRAM STAIN Specimen GS-8 Reaction Labs Percent Performance Gram negative % Acceptable Gram Stain Morphology Rods/bacilli % Acceptable Coccobacilli % Acceptable Diplococci % Organism present in specimen GS-8: Klebsiella pneumoniae. Specimen GS-9 Reaction Labs Percent Performance Gram negative % Acceptable Gram positive % Gram Stain Morphology Diplococci % Acceptable Cocci % Acceptable Coccibacilli % Organism present in specimen GS-9: Neisseria mucosa. Specimen GS-10 Reaction Labs Percent Performance Gram positive % Acceptable Gram negative % Gram Stain Morphology Cocci % Acceptable Diplococci % Acceptable Coccobacilli % Organism present in specimen GS-10: Enterococcus faecalis. 18 / 2015 MLE-M2 Participant Summary
19 AFFIRM VP III Trichomonas vaginalis Specimen VP-6 Positive % Acceptable Organism present in specimen VP-6: Trichomonas vaginalis. Specimen VP-7 Negative % Acceptable Organisms present in specimen VP-7: Candida albicans and Gardnerella vaginalis. Specimen VP-8 Negative % Acceptable Organism present in specimen VP-8: Gardnerella vaginalis. Specimen VP-9 Positive % Acceptable Organism present in specimen VP-9: Gardnerella vaginalis and Trichomonas vaginalis. Specimen VP-10 Negative % Acceptable Organism present in specimen VP-10: Candida albicans MLE-M2 Participant Summary/ 19
20 AFFIRM VP III Gardnerella vaginalis Specimen VP-6 Negative % Acceptable Specimen VP-7 Positive % Acceptable Negative % Specimen VP-8 Positive % Acceptable Specimen VP-9 Positive % Acceptable Specimen VP-10 Negative % Acceptable Positive % AFFIRM VP III Candida sp. Specimen VP-6 Negative % Acceptable Specimen VP-7 Positive % Acceptable Negative % 20 / 2015 MLE-M2 Participant Summary
21 AFFIRM VP III Candida sp. Specimen VP-8 Negative % Acceptable Specimen VP-9 Negative % Acceptable Positive % This specimen was graded by 92% referee consensus. Specimen VP-10 Positive % Acceptable CHLAMYDIA (ANTIGEN DETECTION) Specimen CY-6 ALL METHODS BD ProbeTec 2-2 Cepheid GeneXpert 1-1 Gen-Probe APTIMA 2-2 Quidel QuickVue 6-6 Roche COBAS Amplicor 3-3 Organism present in specimen CY-6: Neisseria gonorrhoeae. Specimen CY-7 ALL METHODS BD ProbeTec Cepheid GeneXpert Gen-Probe APTIMA Quidel QuickVue Roche COBAS Amplicor Organisms present in specimen CY-7: Chlamydia trachomatis and Neisseria gonorrhea MLE-M2 Participant Summary/ 21
22 CHLAMYDIA (ANTIGEN DETECTION) Specimen CY-8 ALL METHODS BD ProbeTec Cepheid GeneXpert Gen-Probe APTIMA Quidel QuickVue Roche COBAS Amplicor Organism present in specimen CY-8: Chlamydia trachomatis. Specimen CY-9 ALL METHODS BD ProbeTec 2-2 Cepheid GeneXpert 1-1 Gen-Probe APTIMA Quidel QuickVue 4-4 Roche COBAS Amplicor 3-3 Organism present in specimen CY-9: No organism present. Specimen CY-10 ALL METHODS BD ProbeTec 2-2 Cepheid GeneXpert 1-1 Gen-Probe APTIMA Quidel QuickVue 4-4 Roche COBAS Amplicor 3-3 Organism present in specimen CY-10: Neisseria gonorrhoeae. 22 / 2015 MLE-M2 Participant Summary
23 GC (ANTIGEN DETECTION) Specimen CY-6 ALL METHODS BD ProbeTec Cepheid GeneXpert Gen-Probe APTIMA Roche COBAS Amplicor Specimen CY-7 ALL METHODS BD ProbeTec Cepheid GeneXpert Gen-Probe APTIMA Roche COBAS Amplicor Specimen CY-8 ALL METHODS BD ProbeTec 2-2 Cepheid GeneXpert 1-1 Gen-Probe APTIMA 2-2 Roche COBAS Amplicor 3-3 Specimen CY-9 ALL METHODS BD ProbeTec 2-2 Cepheid GeneXpert 1-1 Gen-Probe APTIMA 2-2 Roche COBAS Amplicor 3-3 Specimen CY-10 ALL METHODS BD ProbeTec Cepheid GeneXpert Gen-Probe APTIMA Roche COBAS Amplicor MLE-M2 Participant Summary/ 23
24 CRYPTOSPORIDIUM ANTIGEN DETECTION Specimen LC-6 ALL METHODS Antigen present in specimen LC-6: Cryptosporidium. Specimen LC-7 ALL METHODS 1-1 Antigen present in specimen LC-7: Giardia lamblia. Specimen LC-8 ALL METHODS Antigens present in specimen LC-8: Cryptosporidium and Giardia lamblia. Specimen LC-9 ALL METHODS 1-1 Antigen present in specimen LC-9: Giardia lamblia. Specimen LC-10 ALL METHODS 1-1 Antigen present in specimen LC-10: No antigens present. 24 / 2015 MLE-M2 Participant Summary
25 GIARDIA LAMBLIA ANTIGEN DETECTION Specimen LC-6 ALL METHODS 1-1 Specimen LC-7 ALL METHODS Specimen LC-8 ALL METHODS Specimen LC-9 ALL METHODS Specimen LC-10 ALL METHODS MLE-M2 Participant Summary/ 25
26 RSV ANTIGEN DETECTION Specimen V-6 ALL METHODS Alere Binax NOW - waived Alere Clearview RSV - waived 4-4 Quidel QuickVue RSV - waived 8-8 Quidel QuickVue RSV 10 Test 1-1 Quidel Sofia - waived 8-8 Remel Xpect - waived 1-1 Antigen present in specimen V-6: Influenza A. Specimen V-7 ALL METHODS Alere Binax NOW - waived Alere Clearview RSV - waived Quidel QuickVue RSV - waived Quidel QuickVue RSV 10 Test Quidel Sofia - waived Remel Xpect - waived Antigen present in specimen V-7: RSV. Specimen V-8 ALL METHODS Alere Binax NOW - waived 4-4 Alere Clearview RSV - waived 3-3 Quidel QuickVue RSV - waived 4-4 Quidel QuickVue RSV 10 Test 1-1 Quidel Sofia - waived 6-6 Antigen present in specimen V-8: Influenza B. Specimen V-9 ALL METHODS Alere Binax NOW - waived 4-4 Alere Clearview RSV - waived 3-3 Quidel QuickVue RSV - waived 4-4 Quidel QuickVue RSV 10 Test 1-1 Quidel Sofia - waived 6-6 Antigen present in specimen V-9: Influenza A. 26 / 2015 MLE-M2 Participant Summary
27 RSV ANTIGEN DETECTION Specimen V-10 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-10: RSV. INFLUENZA A/B ANTIGEN DETECTION Specimen V-6 ALL METHODS Quidel QuickVue Influenza Antigen present in specimen V-6: Influenza A. Specimen V-7 ALL METHODS Quidel QuickVue Influenza Antigen present in specimen V-7: RSV. Specimen V-8 ALL METHODS Quidel QuickVue Influenza Antigen present in specimen V-8: Influenza B. Specimen V-9 ALL METHODS Quidel QuickVue Influenza Antigen present in specimen V-9: Influenza A MLE-M2 Participant Summary/ 27
28 INFLUENZA A/B ANTIGEN DETECTION Specimen V-10 ALL METHODS Quidel QuickVue Influenza Antigen present in specimen V-10: RSV. INFLUENZA A ANTIGEN DETECTION Specimen V-6 ALL METHODS Alere Binax NOW - waived Alere i Instrument Influenza Alere Influenza A&B BD Veritor - waived Cepheid GeneXpert Henry Schein OneStep+ Flu A&B Labsco Advantage Flu A&B Medline Influenza A&B Quidel QuickVue Influenza A+B Quidel Sofia - waived Remel Xpect Sekisui OSOM Influenza A&B Antigen present in specimen V-6: Influenza A. Specimen V-7 ALL METHODS Alere Binax NOW - waived Alere i Instrument Influenza 1-1 Alere Influenza A&B BD Veritor - waived Cepheid GeneXpert 1-1 Henry Schein OneStep+ Flu A&B 2-2 Labsco Advantage Flu A&B 1-1 Medline Influenza A&B 2-2 Quidel QuickVue Influenza A+B Quidel Sofia - waived Remel Xpect 3-3 Sekisui OSOM Influenza A&B Antigen present in specimen V-7: RSV. 28 / 2015 MLE-M2 Participant Summary
29 INFLUENZA A ANTIGEN DETECTION Specimen V-8 ALL METHODS Alere Binax NOW - waived Alere Influenza A&B 3-3 BD Veritor - waived 3-3 Cepheid GeneXpert 1-1 Labsco Advantage Flu A&B 1-1 Quidel QuickVue Influenza A+B 5-5 Quidel Sofia - waived Remel Xpect 2-2 Sekisui OSOM Influenza A&B Antigen present in specimen V-8: Influenza B. Specimen V-9 ALL METHODS Alere Binax NOW - waived Alere Influenza A&B BD Veritor - waived Cepheid GeneXpert 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-9: Influenza A. Specimen V-10 ALL METHODS Alere Binax NOW - waived Alere Influenza A&B 3-3 BD Veritor - waived 3-3 Cepheid GeneXpert 1-1 Labsco Advantage Flu A&B 1-1 Quidel QuickVue Influenza A+B 5-5 Quidel Sofia - waived Remel Xpect 2-2 Sekisui OSOM Influenza A&B Antigen present in specimen V-10: RSV MLE-M2 Participant Summary/ 29
30 INFLUENZA B ANTIGEN DETECTION Specimen V-6 ALL METHODS Alere Binax NOW - waived Alere i Instrument Influenza 1-1 Alere Influenza A&B BD Veritor - waived Cepheid GeneXpert 1-1 Henry Schein OneStep+ Flu A&B 2-2 Labsco Advantage Flu A&B 1-1 Medline Influenza A&B 2-2 Quidel QuickVue Influenza A+B Quidel Sofia - waived Remel Xpect 4-4 Sekisui OSOM Influenza A&B Antigen present in specimen V-6: Influenza A. Specimen V-7 ALL METHODS Alere Binax NOW - waived Alere i Instrument Influenza 1-1 Alere Influenza A&B BD Veritor - waived Cepheid GeneXpert 1-1 Henry Schein OneStep+ Flu A&B 2-2 Labsco Advantage Flu A&B 1-1 Medline Influenza A&B 2-2 Quidel QuickVue Influenza A+B Quidel Sofia - waived Remel Xpect 4-4 Sekisui OSOM Influenza A&B Antigen present in specimen V-7: RSV. 30 / 2015 MLE-M2 Participant Summary
31 INFLUENZA B ANTIGEN DETECTION Specimen V-8 ALL METHODS Alere Binax NOW - waived Alere Influenza A&B BD Veritor - waived Cepheid GeneXpert 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-8: Influenza B. Specimen V-9 ALL METHODS Alere Binax NOW - waived Alere Influenza A&B 3-3 BD Veritor - waived 3-3 Cepheid GeneXpert 1-1 Labsco Advantage Flu A&B 1-1 Quidel QuickVue Influenza A+B 5-5 Quidel Sofia - waived Remel Xpect 3-3 Sekisui OSOM Influenza A&B Antigen present in specimen V-9: Influenza A. Specimen V-10 ALL METHODS Alere Binax NOW - waived Alere Influenza A&B 3-3 BD Veritor - waived 3-3 Cepheid GeneXpert 1-1 Labsco Advantage Flu A&B 1-1 Quidel QuickVue Influenza A+B 5-5 Quidel Sofia - waived Remel Xpect 3-3 Sekisui OSOM Influenza A&B Antigen present in specimen V-10: RSV MLE-M2 Participant Summary/ 31
32 LEGIONELLA ANTIGEN DETETION Specimen L-6 Binax NOW Specimen L-6: Positive for Legionella antigen. Specimen L-7 Binax NOW Specimen L-7: Negative for Legionella antigen. Specimen L-8 Binax NOW Specimen L-8: Negative for Legionella antigen. Specimen L-9 Binax NOW Specimen L-9: Positive for Legionella antigen. Specimen L-10 Binax NOW Specimen L-10: Positive for Legionella antigen. 32 / 2015 MLE-M2 Participant Summary
33 CLOSTRIDIUM DIFFICILE TOXIN ANTIGEN DETECTION Specimen AG-6 ALL METHODS 7-7 Alere C. diff Quik Chek 5-5 Meridian Illumigene 1-1 Meridian Premier 1-1 Antigen present in specimen AG-6: Rotavirus. Specimen AG-7 ALL METHODS Alere C. diff Quik Chek Meridian Illumigene Meridian Premier Antigen present in specimen AG-7: Clostridium difficile Specimen AG-8 ALL METHODS Alere C. diff Quik Chek Meridian Illumigene Meridian Premier Antigen present in specimen AG-8: Clostridium difficile. Specimen AG-9 ALL METHODS Alere C. diff Quik Chek Meridian Illumigene Meridian Premier Antigens present in specimen AG-9: Clostridium difficile and Rotavirus MLE-M2 Participant Summary/ 33
34 CLOSTRIDIUM DIFFICILE TOXIN ANTIGEN DETECTION Specimen AG-10 ALL METHODS 7-7 Alere C. diff Quik Chek 5-5 Meridian Illumigene 1-1 Meridian Premier 1-1 Antigen present in specimen AG-10: Rotavirus. ROTAVIRUS ANTIGEN DETECTION Specimen AG-6 ALL METHODS Fisher HealthCare Sure-Vue Specimen AG-7 ALL METHODS 6-6 Fisher HealthCare Sure-Vue 6-6 Specimen AG-8 ALL METHODS 6-6 Fisher HealthCare Sure-Vue 6-6 Specimen AG-9 ALL METHODS Fisher HealthCare Sure-Vue / 2015 MLE-M2 Participant Summary
35 ROTAVIRUS ANTIGEN DETECTION Specimen AG-10 ALL METHODS Fisher HealthCare Sure-Vue STREPTOCOCCUS PNEUMONIAE ANTIGEN Specimen SP-6 Binax NOW Specimen SP-6: Positive for Streptococcus pneumoniae antigen. Specimen SP-7 Binax NOW Specimen SP-7: Negative for Streptococcus pneumoniae antigen. Specimen SP-8 Binax NOW Specimen SP-8: Positive for Streptococcus pneumoniae antigen. Specimen SP-9 Binax NOW Specimen SP-9: Negative for Streptococcus pneumoniae antigen. Specimen SP-10 Binax NOW Specimen SP-10: Positive for Streptococcus pneumoniae antigen MLE-M2 Participant Summary/ 35
36 PARASITOLOGY Specimen PA-6 Giardia Lamblia 1 100% Acceptable Parasite present in specimen PA-6: Giardia lamblia. Specimen PA-7 No parasite seen 1 100% Acceptable Parasite present in specimen PA-7: No parasite present. Specimen PA-8 Fasciola hepatica eggs 1 100% Acceptable Parasite present in specimen PA-8: Fasciola hepatica eggs. Specimen PA-9 Diphyllobothrium latum 1 100% Acceptable Parasite present in specimen PA-9: Diphyllobothrium latum. Specimen PA-10 Hookworm 1 100% Acceptable Parasite present in specimen PA-10: Hookworm. Medical Laboratory Evaluation 25 Massachusetts Ave NW Ste 700 Washington, DC Fax: / 2015 MLE-M2 Participant Summary
M E D I C A L L A B O R A T O R Y
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