MALDI Biotyper: Five Facts You Need to Know

 

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MALDI-TOF mass spectrometry offers an effective approach to microorganism identification. Increasing evidence proves its value, leaving many to endorse implementation and routine use of this technology in microbiology laboratories.1,2 

1. The MALDI Biotyper® Speeds Time to Results

Microorganism identification can be achieved in minutes using MALDI-TOF mass spectrometry rather than the one to two days required by traditional methods.3,4 The fast turnaround time helps target antibiotic therapy quickly and correctly to positively impact patient outcomes.2

The MALDI Biotyper reduces time to diagnosis for bacterial infections. The University of Michigan demonstrated that MALDI-TOF sped bacterial identification by over 30 hours compared to a historical control group tested by conventional methods. Time to optimal therapy was reduced by nearly half—to 47.3 hours from 90.3 hours. This led to a 6% decrease in mortality and 6.5-day reduction in ICU stays.5  

MALDI-TOF sped bacterial identification by over 30 hours

Researchers studying the impact of MALDI Biotyper testing on sepsis diagnosis similarly have reported pathogen identification in shorter amounts of time. The reduced incubation period cut identification time by almost 39 hours.
 

2. MALDI-TOF Is Accurate

In addition to speed, accuracy is crucial when it comes to microorganism identification. MALDI-TOF mass spectrometry is highly accurate.4,7,8
The accuracy of the Bruker MALDI Biotyper as a microorganism identification system, together with its associated libraries, is considered comparable to 16S rRNA gene sequencing (the gold standard) and is globally recognized as the clinical laboratory standard for microbial identification. Research shows an accuracy rate of 98.3% for bacteria on the day of cultural growth.1 This 98% accuracy rate at the genus level and >90% at the species level—with <1% incorrectly identified—demonstrate how the MALDI Biotyper has fundamentally altered diagnostic testing due to its combination of accuracy, speed and cost-effectiveness.10

MALDI-TOF accuracy rate of 98.3% for bacteria on the day of cultural growth

3. The MALDI Biotyper Is Cost-effective

The cost-savings benefits of MALDI-TOF mass spectrometry are well demonstrated. Laboratories performing analyses using MALDI-TOF reduce the cost of reagents and save on labor,11 potentially lowering the cost to one-quarter of the total amount for traditional identification methods.11,12

Because of the low cost of reagents for MALDI-TOF, if laboratories were to perform duplicate extraction protocols—one Gram-negative and one Gram-positive—for every sample, they could still save on the cost per sample compared to biochemical phenotyping.4 

Using a cost model translatable to other moderate- to high-volume laboratories, Tan et al. reported a cost savings of $102,424 within a year using MALDI-TOF—a reduction of 56.9%.13

Other researchers explained that, while there was initial expense involved in purchasing the MALDI-TOF mass spectrometry instrumentation, they expected the added savings to offset the cost within three years.1,4 

4. The MALDI Biotyper Is Efficient, Easy to Use and Reproducible

Research indicates that MALDI-TOF mass spectrometry offers laboratories “vast improvements” in laboratory efficiency.4 High-confidence microorganism identification was greater than 96% across multiple clinical sites and countries, illustrating excellent repeatability and reproducibility regardless of the user. This data was generated during clinical and analytical performance studies for Bruker’s MALDI Biotyper (CE-IVD and USA FDA).

 

MALDI-TOF can identify 96% of clinical isolates in a large clinical laboratory

Whereas implementation of new instrumentation in the laboratory can slow workflow and increase labor burden, MALDI-TOF mass spectrometry creates a new workflow that streamlines results delivery.1 Training on the easy-to-operate equipment requires one step—learning to use the analytical software.11 One laboratory reported that training technicians to use MALDI-TOF took only about an hour.1,2 

 

5. The MALDI Biotyper Is Scalable

Benefits must be balanced with costs for any microbiology laboratory system. While it may be easy for larger-volume laboratories to justify adding MALDI-TOF mass spectrometry to their workflows, laboratory professionals familiar with the technology say that laboratories of all sizes can benefit from the speed and accuracy provided by this method of analysis. 

Based on the benefits seen in mid- to large-volume laboratories, the trajectory of the industry and development of technology indicates that small laboratories can take advantage of the accuracy, as well as the time, cost and labor savings of MALDI-TOF mass spectrometry. In fact, not doing so has been called a missed opportunity.2

The “incontrovertibly beneficial” technology can benefit most laboratories, states an industry expert,7 while others recommend that, “every hospital laboratory with a microbiology laboratory should seriously consider implementing MALDI-TOF in the near future.”1
 
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1. “Why Every Hospital Microbiology Laboratory Should Buy a MALDI-TOF.” ClinLab Navigator. http://www.clinlabnavigator.com/maldi-tof.html. Accessed 9 May 2019.
2. Cromien J. “MALDI-TOF is Poised to Speed Diagnosis for Bacterial and Fungal and Infections.” Medical Laboratory Observer (MLO), 21 Nov. 2016. https://www.mlo-online.com/diagnostics/microbiology/article/13008880/malditof-is-poised-to-speed-diagnosis-for-bacterial-and-fungal-infections. Accessed 9 May 2019. 
3. Burckhardt I and Zimmermann S. “Susceptibility Testing of Bacteria Using MALDI-TOF Mass Spectrometry.” Front Microbiol, 2018(Aug); 9:1744.
4. Cherkaoui A et al. Comparison of Two Matrix-Assisted Laser Desorption Ionization-Time of Flight Mass Spectrometry Methods with Conventional Phenotypic Identification for Routine Identification of Bacteria to the Species Level.” J Clin Microbiol, 2010; 48:1169–75.
5. Huang AM et al. “Impact of Rapid Organism Identification via Matrix-Assisted Laser Desorption/Ionization Time-of-Flight Combined With Antimicrobial Stewardship Team Intervention in Adult Patients With Bacteremia and Candidemia.” Clin Infect Dis, 2013, 57; 1237–45.
6. Delport JA et al. “Quality of Care is Improved by Rapid Short Incubation MALDI-ToF Identification from Blood Cultures as Measured by Reduced Length of Stay and Patient Outcomes as Part of a Multi-disciplinary Approach to Bacteremia in Pediatric Patients”. PLoS One. 2016;11(8): e0160618.
7. Patel  R. “MALDI-TOF MS for the Diagnosis of Infectious Diseases. Clin Chem, 2015; 61:100–11. doi:10.1373/clinchem.2014.221770.
8. Dingle TC and Butler-Wu SM. “MALDI-TOF Mass Spectrometry for Microorganism Identification.” Clin Lab Med. 33:589–609. doi:10.1016/j.cll.2013.03.001.
9. Singhal et al. “MALDI-TOF Mass Spectrometry: An Emerging Technology for Microbial Identification and Diagnosis. Front Microbiol. 2015; 6:791.
10. Murray PR. What is New in Clinical Microbiology—Microbial Identification by MALDI-TOF Mass Spectrometry.” J Molecular Diagnos, 2012; 15:419–23.
11. Bizzini A and Greub G. “Matrix-assisted Laser Desorption Ionization Time-of-Flight Mass Spectrometry, A Revolution in Clinical Microbial Identification.” Clin Microbiol Infect, 2010; 16:1614–9.
12. Seng et al. “Ongoing Revolution in Bacteriology: Routine Identification of Bacteria by Matrix-assisted Laser Desorption Ionization Time-of-Flight Mass Spectrometry.” Clin Infect Dis, 2009; 49:543–1.
13. Tan KE et al. “Prospective Evaluation of a Matrix-assisted Laser Desorption Ionization–Time of Flight Mass Spectrometry System in a Hospital Clinical Microbiology Laboratory for Identification of Bacteria and Yeasts: A Bench-by-bench Study for Assessing the Impact on Time to Identification and Cost-effectiveness. “J Clin Microbiol, 2012;50(10):3301–8.
14. Neville et al. “Utility of Matrix-assisted Laser Desorption Ionization—Time of Flight Mass Spectrometry Following Introduction for Routine Laboratory Bacterial Identification.” J Clin Microbiol, 2011; 49:2980–4.