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

Overview

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.

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: 1. Acinetobacter haemolyticus 2. Acinetobacter johnsonii 3. Acinetobacter junii 4. Actinomyces meyeri 5. Actinomyces neuii 6. Actinomyces odontolyticus 7. Actinomyces oris 8. Aerococcus urinae 9. Aerococcus viridans 10. Aeromonas salmonicida 11. Anaerococcus vaginalis 12. Bacteroides fragilis 13. Bacteroides uniformis 14. Bacteroides\_ovatus group 15. Bacteroides\_thetaiotaomicron group 16. Bacteroides\_vulgatus group 17. Bordetella group\[3\] 18. Bordetella hinzii 19. Brevibacterium casei 20. Brevundimonas\_diminuta group 21. Campylobacter coli 22. Campylobacter jejuni 23. Campylobacter ureolyticus 24. Candida albicans 25. Candida boidinii 26. Candida dubliniensis 27. Candida duobushaemulonii 28. Candida famata 29. Candida glabrata 30. Candida guilliermondii 31. Candida haemulonis 32. Candida inconspicua 33. Candida kefyr 34. Candida krusei 35. Candida lambica 36. Candida lipolytica 37. Candida lusitaniae 38. Candida metapsilosis 39. Candida norvegensis 40. Candida orthopsilosis 41. Candida parapsilosis 42. Candida pararugosa 43. Candida pelliculosa 44. Candida tropicalis 45. Candida valida 46. Capnocytophaga ochracea 47. Capnocytophaga sputigena 48. Chryseobacterium gleum 49. Chryseobacterium indologenes 50. Clostridium difficile 51. Clostridium perfringens 52. Corynebacterium amycolatum 53. Corynebacterium bovis 54. Corynebacterium diphtheriae 55. Corynebacterium glucuronolyticum 56. Corynebacterium jeikeium 57. Corynebacterium kroppenstedtii 58. Corynebacterium macginleyi 59. Corynebacterium minutissimum 60. Corynebacterium propinquum 61. Corynebacterium pseudodiphtheriticum 62. Corynebacterium riegelii 63. Corynebacterium tuberculostearicum 64. Corynebacterium ulcerans 65. Corynebacterium urealyticum 66. Corynebacterium xerosis 67. Corynebacterium\_aurimucosum group 68. Corynebacterium\_striatum group 69. Cronobacter\_sakazakii group 70. Cryptococcus gattii 71. Cryptococcus neoformans\_var\_grubii 72. Cryptococcus neoformans\_var\_neoformans 73. Cupriavidus\_pauculus group 74. Delftia\_acidovorans group 75. Dermacoccus nishinomiyaensis 76. Edwardsiella tarda 77. Elizabethkingia\_meningoseptica group 78. Enterobacter amnigenus 79. Enterococcus casseliflavus 80. Enterococcus faecalis 81. Enterococcus faecium 82. Enterococcus gallinarum 83. Enterococcus hirae 84. Enterococcus\_avium group 85. Finegoldia magna 86. Fusobacterium canifelinum 87. Fusobacterium necrophorum 88. Fusobacterium nucleatum 89. Gardnerella vaginalis 90. Gemella haemolysans 91. Gemella sanguinis 92. Geotrichum candidum 93. Geotrichum capitatum 94. Granulicatella adiacens 95. Haemophilus haemolyticus 96. Haemophilus influenzae 97. Haemophilus\_parahaemolyticus group 98. Kingella kingae 99. Kloeckera apiculata 100. Kocuria kristinae 101. Kytococcus sedentarius 102. Lactococcus garvieae 103. Lactococcus lactis 104. Leuconostoc mesenteroides 105. Macrococcus caseolyticus 106. Micrococcus luteus 107. Moraxella\_sg\_Moraxella nonliquefaciens 108. Myroides odoratimimus 109. Myroides odoratus 110. Oligella ureolytica 111. Oligella urethralis 112. Parabacteroides distasonis 113. Pediococcus pentosaceus 114. Peptoniphilus\_harei group 115. Peptostreptococcus anaerobius 116. Pichia ohmeri 117. Plesiomonas shigelloides 118. Porphyromonas gingivalis 119. Prevotella bivia 120. Prevotella buccae 121. Prevotella denticola 122. Prevotella intermedia 123. Prevotella melaninogenica 124. Propionibacterium acnes 125. Pseudomonas stutzeri 126. Rhizobium radiobacter 127. Rothia aeria 128. Rothia dentocariosa 129. Rothia mucilaginosa 130. Saccharomyces cerevisiae 131. Serratia plymuthica 132. Serratia rubidaea 133. Staphylococcus aureus 134. Staphylococcus auricularis 135. Staphylococcus capitis 136. Staphylococcus caprae 137. Staphylococcus carnosus 138. Staphylococcus cohnii 139. Staphylococcus epidermidis 140. Staphylococcus equorum 141. Staphylococcus felis 142. Staphylococcus haemolyticus 143. Staphylococcus hominis 144. Staphylococcus lugdunensis 145. Staphylococcus pasteuri 146. Staphylococcus pettenkoferi 147. Staphylococcus pseudintermedius 148. Staphylococcus saccharolyticus 149. Staphylococcus saprophyticus 150. Staphylococcus schleiferi 151. Staphylococcus simulans 152. Staphylococcus vitulinus 153. Staphylococcus warneri 154. Streptococcus agalactiae 155. Streptococcus anginosus 156. Streptococcus constellatus 157. Streptococcus dysgalactiae 158. Streptococcus gallolyticus 159. Streptococcus gordonii 160. Streptococcus intermedius 161. Streptococcus lutetiensis 162. Streptococcus mutans 163. Streptococcus pneumoniae 164. Streptococcus pyogenes 165. Streptococcus salivarius 166. Streptococcus\_mitis\_oralis group 167. Sutterella wadsworthensis 168. Trichosporon asahii 169. Vibrio parahaemolyticus 170. Vibrio vulnificus sg = subgenus sp=species var = variety

Conditions

Eligibility

Locations (1)

Outcomes