MYCOFAST RevolutioN

MYCOFAST RevolutioN

Detection, enumeration, identification and complete antimicrobial susceptibility testing of urogenital mycoplasma: DIRECT METHOD

The MYCOFAST® RevolutioN is an accurate, cost-effective, easy-to-use colorimetric assay designed for the detection, enumeration, identification and antibiotic susceptibility determination of Ureaplasma urealyticum (U.u.) and Mycoplasma hominis (M.h.) from urogenital specimens.

The MYCOFAST® RevolutioN enables labs to determine susceptibility to a panel of new antibiotics, helping physicians comply with the latest therapeutic guidelines from CLSI (Clinical Laboratories Standards Institute). The addition of the MYCOFAST® RevolutioN expands ELITech’s family of mycoplasma test solutions, offering the most extensive antibiotic susceptibility determination at key clinical end-points.

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  • Description
  • Features
  • Specifications

Description

The MYCOFAST® RevolutioN enables labs to determine susceptibility to a panel of new antibiotics, helping physicians comply with the latest therapeutic guidelines from CLSI (Clinical Laboratories Standards Institute). The addition of the MYCOFAST® RevolutioN expands ELITech’s family of mycoplasma test solutions, offering the most extensive antibiotic susceptibility determination at key clinical end-points.

  • All-in-one test
  • Antibiotics FULLY compliant with new worldwide recommendations
  • Fast results for clinicians, available within 24 hours
  • Visual colorimetric method, without expert interpretation
  • Specimen preserved up to 72 hours before analysis
  • Ready to use reagents, “all-liquid method”
  • New closing system for secure operation
  • Results in accordance with pathological ratios

Featuring ready-to-use reagents and an “all liquid” method, MYCOFAST® RevolutioN identifies the growth of U.u. and M.h. after 24 hours of incubation. Our exclusive growth activator, the M.h. Supplement, guarantees fast and accurate results.
Moreover, MYCOFAST® RevolutioN enables the enumeration of U.u.  > 10UCC/mL which is compliant with pathological thresholds recognized for sperm and urine samples.

Finally, the new UMMt RevolutioN transport medium enables optimized sample management by preserving specimen integrity up to 72 hours.

Intended use

Mycoplasmas are the smallest and simplest of the procaryotypes capable of self-reproduction (0.15 to 0.25 μm). They differ from other bacteria in their lack of a cell wall and hence a natural resistance to ß-lactams. Since mycoplasmas are relatively fragile, they will only grow in acellular cultures in the presence of various growth factors and at a constant temperature of 35 to 37 °C.

Most human mycoplasmas are commensal. Of the 9 species that have been isolated from the urogenital tract, Ureaplasma urealyticum and Mycoplasma hominis are the most commonly found. U.u. and M.h. are sexually transmitted and can be pathogenic. Respiratory infections or meningitis can occur in the neonate as a result of contamination from the genital tract at birth. In adults, the infections caused by U.u. and M.h. are described in the table below:

Conventional diagnosis is based upon culture on A7 agar plates followed by microscopical identification of U.u. (sea urchin shaped) or M.h. (fried-egg shaped) colonies.
Since both U.u. and M.h. are commensal, infection can only be diagnosed through the determination of the pathological threshold, followed by precise enumeration.

MYCOFAST® RevolutioN gives the solution and makes your urogenital diagnosis much easier.


Principle

MYCOFAST® RevolutioN identifies U.u. and M.h. growth after 24 hours of incubation in a liquid medium. During growth, U.u. and M.h. metabolize urea and arginine respectively resulting in a color change of the medium, which contains phenol red indicator, from yellow-orange to red. This color change is due to liberation of ammonia resulting in an alkaline pH of the medium.

Mycoplasma growth thus viewed enables:

  • Enumeration of mycoplasma based on the rate of urea or arginine hydrolysis, which is proportional to the number of germs contained in the sample.
    U.u:  > 103, 104 and 105 UCC/ml
    M.h: > 104 UCC/ml
  • Identification based on the sensitivity or otherwise of the germ to three antibiotics (lincomycin, SXT and erythromycin) = Identibiotic.
  • U.u and M.h susceptibility testing to 5 antibiotics compliant with new worldwide recommendations:
    Levofloxacin (LVX) 1-2-4 μg/mL ,  Moxifloxacin (MXF) 0.25-2 μg/mL , Erythromycin (E) 8-16 μg/mL, Clindamycin (CM) 0.25-0.5 μg/mL and Tetracyclin (TE) 1-2-4-8 μg/mL.

Easy-to-read and easy-to-interpret results

The results are read by the color obtained in the different wells. Urogenital mycoplasma growth is indicated when the medium turns red (alkaline). The medium remains yellow when no growth of urogenital mycoplasma occurs.

Reagents and material

  • UMMt: Vial of 3 mL mycoplasma broth with antimicrobial agents and preservative solution. pH: 6.0 ± 0.1 25
    Quantity: 25
  • MYCOFAST® RevolutioN: Tray of 20 wells packed in an aluminium sachet with an integrated desiccant
    Quantity: 25
  • S. M.h. : vial of 4.5 mL Mycoplama hominis growth activator
    Quantity: 2
  • Closing system: Protective translucent plastic tray lid
    Quantity: 25

Material required but not provided

Sample collecting material (Swabs, cytobrushes, sterile containers for liquid samples)

  • MYCOPLASMA Stabilizer (REF 00064)
  • Pipettes and tips
  • Waste container for contaminated waste
  • Mineral oil
  • Incubator at 37 ± 1 °C

Stability and storage

  • All the reagents are ready-to-use. The vials may be stored at 2-8 °C, in their original packaging until the expiry date shown on the kit.
  • The UMMt medium may be stored temporarily at room temperature but is more stable at
    2-8 °C.
  • The S.Mh supplement is stable for 3 months after opening.
  • Do not freeze the reagents contained in the kit.