Evaluation of MALDI Biotyper CA System for Detection of Gram- and Gram+ Bacteria and Yeasts

Study Overview
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Brief Summary
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The study objective is to confirm that the MBT-CA System identifies medically significant bacteria and yeasts from an isolated colony from any sample type processed by the clinical laboratory. For this purpose MBT-CA test results will be compared to bi-directional sequencing results.

Detailed Description
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Bacteria or yeast isolates (1) fresh from primary culture plates, (2) collected directly from clinical samples, stored in the refrigerator or frozen or (3) well characterized organisms from a variety of contemporary culture collections will be included in the study. All organisms to be included in the study will be cultured on an agar medium prior to measurement. Testing will be performed for various Gram negative and Gram positive bacteria and yeasts as outlined below. Several thousands of samples will be measured via MBT-CA systems based on MALDI-TOF MS technology (matrix assisted laser desorption ionisation time-of-flight mass spectrometry) at the test sites as fresh or frozen isolates of bacteria and yeasts. Lower prevalence organisms may be supplemented from banked culture collections. The MBT-CA system uses an organism identification based on unique protein patterns of the microorganisms obtained from mass spectrometry. The test organism's spectrum (a pattern of mass peaks) is compared with a reference spectra library (database). Using biostatistical analysis, a probability ranking of the organism identification is generated. The probability ranking is represented as a log(score) between 0.00 and 3.00. Organism identification is reported with high confidence if the log(score) is ≥ 2.00. An organism identification is reported with low confidence if the log(score) is between 1.70 and <2.00. In the last step the samples are sent to a special site for sequencing. Finally, the respective sequencing results are compared with the MBT-CA results. Target microorganisms of study: Acinetobacter haemolyticus Acinetobacter johnsonii Acinetobacter junii Actinomyces meyeri Actinomyces neuii Actinomyces odontolyticus Actinomyces oris Aerococcus urinae Aerococcus viridans Aeromonas salmonicida Anaerococcus vaginalis Bacteroides fragilis Bacteroides uniformis Bacteroides_ovatus group Bacteroides_thetaiotaomicron group Bacteroides_vulgatus group Bordetella group[3] Bordetella hinzii Brevibacterium casei Brevundimonas_diminuta group Campylobacter coli Campylobacter jejuni Campylobacter ureolyticus Candida albicans Candida boidinii Candida dubliniensis Candida duobushaemulonii Candida famata Candida glabrata Candida guilliermondii Candida haemulonis Candida inconspicua Candida kefyr Candida krusei Candida lambica Candida lipolytica Candida lusitaniae Candida metapsilosis Candida norvegensis Candida orthopsilosis Candida parapsilosis Candida pararugosa Candida pelliculosa Candida tropicalis Candida valida Capnocytophaga ochracea Capnocytophaga sputigena Chryseobacterium gleum Chryseobacterium indologenes Clostridium difficile Clostridium perfringens Corynebacterium amycolatum Corynebacterium bovis Corynebacterium diphtheriae Corynebacterium glucuronolyticum Corynebacterium jeikeium Corynebacterium kroppenstedtii Corynebacterium macginleyi Corynebacterium minutissimum Corynebacterium propinquum Corynebacterium pseudodiphtheriticum Corynebacterium riegelii Corynebacterium tuberculostearicum Corynebacterium ulcerans Corynebacterium urealyticum Corynebacterium xerosis Corynebacterium_aurimucosum group Corynebacterium_striatum group Cronobacter_sakazakii group Cryptococcus gattii Cryptococcus neoformans_var_grubii Cryptococcus neoformans_var_neoformans Cupriavidus_pauculus group Delftia_acidovorans group Dermacoccus nishinomiyaensis Edwardsiella tarda Elizabethkingia_meningoseptica group Enterobacter amnigenus Enterococcus casseliflavus Enterococcus faecalis Enterococcus faecium Enterococcus gallinarum Enterococcus hirae Enterococcus_avium group Finegoldia magna Fusobacterium canifelinum Fusobacterium necrophorum Fusobacterium nucleatum Gardnerella vaginalis Gemella haemolysans Gemella sanguinis Geotrichum candidum Geotrichum capitatum Granulicatella adiacens Haemophilus haemolyticus Haemophilus influenzae Haemophilus_parahaemolyticus group Kingella kingae Kloeckera apiculata Kocuria kristinae Kytococcus sedentarius Lactococcus garvieae Lactococcus lactis Leuconostoc mesenteroides Macrococcus caseolyticus Micrococcus luteus Moraxella_sg_Moraxella nonliquefaciens Myroides odoratimimus Myroides odoratus Oligella ureolytica Oligella urethralis Parabacteroides distasonis Pediococcus pentosaceus Peptoniphilus_harei group Peptostreptococcus anaerobius Pichia ohmeri Plesiomonas shigelloides Porphyromonas gingivalis Prevotella bivia Prevotella buccae Prevotella denticola Prevotella intermedia Prevotella melaninogenica Propionibacterium acnes Pseudomonas stutzeri Rhizobium radiobacter Rothia aeria Rothia dentocariosa Rothia mucilaginosa Saccharomyces cerevisiae Serratia plymuthica Serratia rubidaea Staphylococcus aureus Staphylococcus auricularis Staphylococcus capitis Staphylococcus caprae Staphylococcus carnosus Staphylococcus cohnii Staphylococcus epidermidis Staphylococcus equorum Staphylococcus felis Staphylococcus haemolyticus Staphylococcus hominis Staphylococcus lugdunensis Staphylococcus pasteuri Staphylococcus pettenkoferi Staphylococcus pseudintermedius Staphylococcus saccharolyticus Staphylococcus saprophyticus Staphylococcus schleiferi Staphylococcus simulans Staphylococcus vitulinus Staphylococcus warneri Streptococcus agalactiae Streptococcus anginosus Streptococcus constellatus Streptococcus dysgalactiae Streptococcus gallolyticus Streptococcus gordonii Streptococcus intermedius Streptococcus lutetiensis Streptococcus mutans Streptococcus pneumoniae Streptococcus pyogenes Streptococcus salivarius Streptococcus_mitis_oralis group Sutterella wadsworthensis Trichosporon asahii Vibrio parahaemolyticus Vibrio vulnificus sg = subgenus sp=species var = variety

Official Title
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Method Comparison Protocol: MALDI Biotyper-Clinical Applications (MBT-CA) Phase 2

Conditions
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Infection

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -Patients with infections from certain yeasts, Gram positive or Gram negative bacteria (see Detailed Description) Exclusion Criteria: -Patients without infections from the quoted microorganisms (see Detailed Description)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Substantial equivalence of MBT-CA with sequencing concerning determination of the respective bacteria and yeasts |  | half a year |