Mycology · Antifungal AST · Class 2 IVD · ARTG 524158

FMIC
Fungal MIC Test Strips

Quantitative antifungal MIC determination for clinically significant yeasts and moulds. EUCAST AFST-aligned gradient diffusion methodology on RPMI 1640 agar — optimised for hospital mycology and reference laboratories. TGA-registered Class 2 IVD — ARTG 524158.

BioMaxima
Azoles · Echinocandins · Polyenes
RPMI 1640 agar · EUCAST AFST
Candida · Aspergillus · Moulds
Pack sizes: 10, 30
TGA Registered · ARTG 524158
Product Overview

FMIC — Antifungal Susceptibility Testing

The BioMaxima Fungal MIC Strip (FMIC) delivers quantitative minimum inhibitory concentration (MIC) values for antifungal agents against clinically significant yeasts and moulds using a validated gradient diffusion principle on solid RPMI 1640 agar. A precise antifungal concentration gradient is immobilised along the length of the strip. After lawn inoculation and incubation, an elliptical inhibition zone forms and the MIC is read at the point of intersection with the graduated scale.

The FMIC system supports azole, echinocandin, polyene, and 5-flucytosine susceptibility testing, covering all major antifungal drug classes relevant to candidiasis, invasive aspergillosis, and other systemic fungal infections. Results are interpreted using current EUCAST antifungal susceptibility testing (AFST) breakpoints and, where applicable, EUCAST epidemiological cut-off values (ECOFFs).

FMIC strips are placed on RPMI 1640 agar inoculated with the test organism. After 24 h (Candida) or 48 h (moulds) incubation at 35 ± 1°C, the MIC is read at the point where the ellipse intersects the graduated scale. No serial dilution preparation is required.

Results are interpreted using the current annual edition of EUCAST Clinical Breakpoint Tables or CLSI M100, classifying isolates as S (susceptible), I (susceptible at increased exposure), or R (resistant).

At a Glance
1
Test PlatformGradient diffusion on RPMI 1640 agar — EUCAST AFST aligned
2
Target OrganismsAerobic and facultatively anaerobic bacteria — routine clinical isolates
3
Test MediumRPMI 1640 + 2% glucose + 0.165 M MOPS, pH 7.0 ± 0.1
4
Incubation35 ± 1°C / 16–20 hours (EUCAST / CLSI conditions)
5
ResultMIC in µg/mL — complete inhibition (most agents); ≥50% inhibition (echinocandins)
6
Pack Sizes10, 30, and 100 tests — individually packaged strips
Patented Technology

Why BioMaxima FMIC Strips

Developed through university research partnerships and a patented composite substrate — delivering consistent, reproducible gradient diffusion AST.

Patented

Biomedical Composite Carrier

FMIC strips use BioMaxima's patented biomedical composite carrier — delivering precise, consistent antifungal diffusion across all 15 two-fold dilution steps with exceptional lot-to-lot reproducibility. Critical for antifungal AST where narrow MIC distributions require accurate gradient delivery.

Research-backed

University-Validated Technology

The MIC test platform was developed through a five-year research programme (2017–2022) in collaboration with UMCS Lublin (Departments of Genetics and Microbiology, and Biochemistry) and the Medical University of Lublin — with two patent applications filed as a result.

Standards

EUCAST & CLSI Aligned

FMIC methodology is validated to EUCAST E.DEF 7.3.2 (Candida) and E.DEF 9.3.1 (Aspergillus) reference standards. Results interpreted using current EUCAST AFST clinical breakpoints and ECOFFs from eucast.org/antifungal_susceptibility_testing/.

Efficiency

No Serial Dilution Required

Unlike EUCAST broth microdilution (the AFST reference method), FMIC strips require no preparation of antifungal dilution series. A single strip on RPMI 1640 agar delivers the full 15-step gradient — simplifying antifungal AST without sacrificing accuracy.

Versatile

Standard Laboratory Infrastructure

FMIC testing requires RPMI 1640 agar, an incubator, and a turbidity standard. No specialist mycology analyser required. Compatible with existing MIC strip applicators. Results in 24 h (Candida) or 48 h (Aspergillus/moulds).

Stewardship

Supports AMR Stewardship

Quantitative MIC values in µg/mL support PK/PD-guided dose optimisation, enabling clinicians and stewardship pharmacists to tailor antibiotic regimens — supporting responsible antimicrobial use and contributing to the reduction of antimicrobial resistance.

Antibiotic Coverage

FMIC Antifungal Panel — Drug Classes & Organisms

The FMIC range covers all major antifungal drug classes. Individual strips are available for each agent. Contact Advanced Biotech for the current full agent list and catalogue numbers.

PenicillinsAmoxicillin, Ampicillin, Piperacillin, Ticarcillin
β-lactam/InhibitorAmox/Clav, Pip/Tazo, Amp/Sulb
CephalosporinsCefazolin, Cefuroxime, Ceftriaxone, Cefepime
CarbapenemsImipenem, Meropenem, Ertapenem, Doripenem
AminoglycosidesGentamicin, Tobramycin, Amikacin, Netilmicin
FluoroquinolonesCiprofloxacin, Levofloxacin, Moxifloxacin, Norfloxacin
TetracyclinesTetracycline, Doxycycline, Minocycline, Tigecycline
GlycopeptidesVancomycin, Teicoplanin
MacrolidesErythromycin, Clarithromycin, Azithromycin
SulfonamidesTrimethoprim, Trimethoprim/Sulfa
PolymyxinsColistin, Polymyxin B
Other AgentsChloramphenicol, Rifampicin, Linezolid, Fosfomycin
Ordering

Pack Sizes

FMIC strips are individually packaged per antifungal agent. Contact Advanced Biotech for pricing, catalogue numbers, and current availability.

10
Tests per pack

Suitable for low-throughput testing, evaluation, or infrequent use of specific agents. Individually packaged strips maintain stability and reduce waste.

Enquire
30
Tests per pack

Standard pack size for routine clinical laboratory use. Cost-effective for regular AST workflows without requiring bulk storage of high-volume packs.

Enquire
100
Tests per pack

High-volume pack for reference laboratories, high-throughput clinical settings, or institutions requiring bulk supply of frequently tested agents.

Enquire
Specifications

Technical Specifications

Key technical parameters for the FMIC Fungal MIC Test Strip.

ParameterSpecification
Product nameBioMaxima Fungal MIC Strip (FMIC)
PlatformGradient diffusion minimum inhibitory concentration (MIC) test
Target organismsAerobic and facultatively anaerobic bacteria (routine clinical isolates)
Antibiotic coverageBroad panel — major antibacterial agent classes (contact Advanced Biotech for current full list)
Dilution range15 two-fold dilution steps — factory-calibrated continuous gradient
Test mediumMueller-Hinton agar (standard formulation, EUCAST/CLSI specification)
Inoculum0.5 McFarland turbidity standard — direct colony suspension method
Incubation temperature35 ± 1°C
Incubation duration16–20 hours (refer to IFU for organism-specific conditions)
MIC readingµg/mL — read at ellipse/strip intersection point
Breakpoint standardsEUCAST Clinical Breakpoint Tables (current edition) / CLSI M100
Pack sizes10, 30, 100 tests — individually packaged strips
Storage2–8°C (refer to product label and IFU)
Regulatory categoryClass 2 IVD — for in vitro diagnostic use only
ARTG number524158
ManufacturerBioMaxima S.A., Lublin, Poland
Australian distributorAdvanced Biotech Pty Ltd
Documentation

Downloads

Instructions for Use, Safety Data Sheet, and regulatory documentation for FMIC Fungal MIC Test Strips.

TGA
TGA Registered · Class 2 IVDARTG 524158 · Australian Sponsor: Advanced Biotech Pty Ltd
ISO 13485
ISO 13485 CertifiedBioMaxima S.A. quality management system
CE
CE MarkedEU IVD Directive conformity

Order FMIC or Request Technical Information

Contact Advanced Biotech Pty Ltd for pricing, catalogue numbers, pack sizes, and availability of FMIC Fungal MIC Test Strips in Australia.