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haemophilus test medium htm
Clinical Standards Laboratories
Summary: The Haemophilus Test Medium (HTM) is used for susceptibility testing of Haemophilus species. It is primarily used in laboratory settings to assess antibiotic efficacy. Key evidence indicates variability in growth performance across different HTM preparations.
FDA Clearance Information
Pathway
510K
Number
K952595 ↗
Decision Date
April 10, 1996
Product Code
JSO
Device Class
Class 2
Evidence
419 studies
The Haemophilus Test Medium HTM was cleared by the FDA via the 510(k) pathway on April 10, 1996. It is manufactured by Clinical Standards Laboratories and classified as a Class 2 device.
What It Is
The Haemophilus Test Medium (HTM) is a specialized culture medium designed for the disk diffusion susceptibility testing of Haemophilus species. It is intended for use in clinical laboratories to determine the antibiotic susceptibility of these bacteria.
Clinical Applications
HTM is commonly used in clinical microbiology laboratories to perform antimicrobial susceptibility testing of Haemophilus influenzae and related species. It provides a standardized method for assessing the effectiveness of antibiotics against these pathogens.
Evidence Summary
The available literature includes 10 studies, primarily from the mid-1990s, assessing the performance of HTM in antibiotic susceptibility testing. Study types include comparisons with other media and evaluations of interpretive criteria.
Reported Outcomes
Published studies report that HTM provides comparable results to other media for antibiotic susceptibility testing of Haemophilus species. However, some studies noted insufficient growth in certain strains, particularly beta-lactamase-negative, ampicillin-resistant strains.
Safety Profile
Reported complications include variability in growth performance, which may affect the accuracy of susceptibility testing. No direct adverse events related to HTM use were reported in the studies.
Evidence Limitations
The evidence is limited by the age of the studies, with most conducted in the 1990s. There is a need for updated research to confirm the current performance of HTM and to explore its efficacy with newer antibiotics.
Linked Studies (20)
PubMed • 2025
Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.
Journal of neuroendovascular therapy
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Performance evaluation of quantitative hemoglobin A2 and fetal hemoglobin testing using commercially lyophilized vs. in-house whole blood controls in Chinese clinical laboratories: a 12-year analysis of National External Quality Assessment Data.
Clinical chemistry and laboratory medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Clinical progress note: Haemophilus influenzae type b.
Journal of hospital medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Pilot study of social media promotion of home-based self-testing for syphilis.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Clinical development and performance of the First to Know Syphilis Self-Test for over-the-counter usage: a de novo rapid test for treponemal antibody.
Journal of clinical microbiology
View Source →
PubMed • 2025
Implementation of an Opt-Out and Rapid Point-of-Care Syphilis Testing Program for Pregnant Patients Presenting to the Emergency Department.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Evaluation of Rapid Syphilis Testing Using the Syphilis Health Check in Florida, 2015-2016.
Florida public health review
View Source →
PubMed • 2025
Multiplex droplet digital PCR for the detection and quantitation of Streptococcus pneumoniae, Mycoplasma pneumoniae, and Haemophilus influenzae.
Frontiers in cellular and infection microbiology
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Palm Multidiagnostic of Mycoplasma pneumoniae, Chlamydia pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae Using One-Tube CRISPR/Cas12a.
Transboundary and emerging diseases
View Source →
PubMed • 2025
Tp40: a new potential prognostic and diagnostic marker for syphilis.
Microbiology spectrum
View Source →
PubMed • 2025
Serotonin sets up neutrophil extracellular traps to promote neuroendocrine prostate cancer metastasis in the liver.
The Journal of clinical investigation
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Application value of Philips Ingenuity TF PET/CT scanner imaging agent FAP in evaluating renal fibrosis.
Hellenic journal of nuclear medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Message from Dr. Philippe T. Georgel, Guest Editor for the Marshall University Collection, Brad D. Smith, President of Marshall University, and Dr. Anivandan Mukherjee, Provost of Marshall University.
Biochemistry and cell biology = Biochimie et biologie cellulaire
View Source →
PubMed • 2025
Improved patient comfort and procedural efficiency using chlorhexidine-coated hydrophilic urethral catheters: a randomized controlled trial.
Journal of Yeungnam medical science
RCT View Source →
PubMed • 2025
pTx-Pulseq in hybrid sequences: Accessible and advanced hybrid open-source MRI sequences on Philips scanners.
Magnetic resonance in medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Comparative connectomics of Drosophila descending and ascending neurons.
Nature
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Hydrophilic-coated sheaths for reducing radial artery spasm during transradial procedures: A systematic review and meta-analysis.
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
View Source →
PubMed • 2025
History of antineutrophil cytoplasmic autoantibodies : Milestones in rheumatology.
Zeitschrift fur Rheumatologie
View Source →
PubMed • 2025
A Hydrophilic Polyurethane Foam Containing Nigella sativa Oil as a Wound Dressing.
BioMed research international
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What are the clinical indications for Haemophilus Test Medium HTM?
HTM is indicated for use in susceptibility testing of Haemophilus species to determine antibiotic efficacy.
What outcomes have been reported in clinical studies?
Studies report that HTM provides reliable results for antibiotic susceptibility testing, though some variability in growth performance has been noted.
What complications have been reported?
Reported complications include variability in growth performance, potentially affecting test accuracy.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.