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AFIAS-10
- FEATURES
- PRINCIPLE OF OPERATION
- TECHNICAL DATA
- ASSAY MENU
- MULTIMEDIA
- PUBLICATIONS
SAMPLE-TO-RESULTS SYSTEM for the small lab or emergency setting
AFIAS-10 is the tailored solution adapted to the labs individual needs. A full automatic and integrated sample-to-result system, easy to use, versatile and flexible that can execute from 1 to 10 tests in parallel, from blood tubes, swabs or capillary samples. AFIAS-10 is a cost-effective solution that offer a very extensive immuno-assay menu. This fast solution will provide quick results to clinician to improve the outcome of the patient.
FLEXIBLE
- Only one system for both routine and STAT emergency testing
- Diversified menu covering many disease areas (over 50 parameters)
- Wide range of sample types available (whole blood, serum, plasma, nasopharyngeal swab)
- Wide range sampling options (automatic from primary tube, C-tip capillary, pipette)
- 10 parallel tests of different parameters at the same time
FAST
- Result available from 3 min (CRP) and for msot assays in 10-12 min
- Minimal manual hands-on with ready to use All-in One cartridges and ID chip calibration
- Minimal sample preparation required (capillary blood)
- Always ready for urgent tests with the STAT mode
- No manual input of patient data with bi-directional LIS and HIS connectivity
EASY TO USE
- No reagent preparation require with the All-in One cartridge system
- No manual calibration with ID chip
- Room temperture storage for most reagents
- Bi-directional LIS and HIS minimises manual handling
COST-EFFICIENT
- High throughput: up to 50 tests/hour with automated results generation
- Perform both routine and STAT testing with one system
- All-in One cartridge system with all components included
- ID chip calibration saves time and cost
- Minimal operator maintenance
- 24 test pack regent kits with excellent stability
AFIAS-10 is available in the following A.Menarini Diagnostics territories/countries:
European Union
United Kingdom
Switzerland
Norway
Iceland
Montenegro
Albania
North Macedonia
The routine AFIAS-10 testing workflow consists of five (5) main operator steps (LIS workflow)
**ID chip registration only required first time or a lot change
*Time to result varied based on test but mostly 10-12 min (varies between 3 min up to 28 min)
Brochure available here:
In the TRF method (Time Resolved Fluorescence), the light source does not emit continuous light radiation, but emits flashes of light (red rectangle). Since chromogen (europium chelates) has a certain inertia, it continues to emit fluorescence for a short period even after the flash of light (black line in the figure), as well as any background fluorescence (green area in the figure). The system detects only the residual fluorescence between one flash of light and the next (yellow area in the figure), where there is neither direct light from the source or that generated by the background radiation.
The innovative and disposable all-in-one cartridge is based on a lab-on-cartridge architecture: it contains all the necessary reagents to run the chemical reaction and enables a full automation of the testing.
AFIAS CARTRIDGE
AFIAS-10 SYSTEM TECHNICAL SPECIFICATION
INTENDED USE
The AFIAS-10 is a medical immunofluorescence analyser that can be used with a variety of immunofluorescence test cartridges. The sample can be blood, urinary and other samples depending on the type of test performed.
Physical Properties
Dimensions (W x H x D)
Weight
Memory
426 x 443 x 395 mm
20.8 kg
10,000 patient + QC results
100 ID chips /10 User lD
ANALYSIS METHOD
Fluorescence-based Lateral Flow Immunoassay
FUNCTIONAL SPECIFICATIONS
10 channels with 2 bays
Multiple tests parameters
from one sample
Each bay can be operated separately
10 different tests in parallel or 10 samples with the same test
Throughput
Up to 50 tests per hour*
SAMPLE TYPES AND SAMPLIN OPTIONS
Various types of sampling from primary tubes, capillary, c-tip and pipette
Various types of sample tube available
C-tip only 10ul to 30 ul blood required
Blood collection tube (0.5 & 3.0 & 5 ml)
Microcentrifuge tube (0.5 & 1.5 ml)
Swabs
User interface
Display
Barcode reader (integrated)
Data export/connecivity
LIS integration
Internal printer
10.1” TFT LCD touch screen
RS232C, 3 USB port, 1 mini USB port, LAN port, SD card slot
Bidirectional LIS/HIS function
optical system
Illuminant
Receiver
Laser Diode
Silicone photo diodes
Maintenance
Calibration
Maintenance
ID chip registration only first time and when lot changed.
Wash cartridge after every 100 tests takes 3 min only
OPERATIONAL CONDITIONS
Temperature
Other conditions
15–35 ℃
Avoid direct sunlight, mechanical vibration and magnetic fields, and install on dry and clean, flat horizontal surfaces
ELECTRICAL SPECIFICATIONS
Power requirements
100 – 240 Vac; 50 – 60 Hz, 2.6-1.0 A
OTHER SPECIFICATIONS
Laser
Class 1
Radiation wave: 635 nm
Radiate Angle: Equilibrium Light Impulse cycle: -
Maximum radial power: < 1 mW
SAFETY
Cross contamination: Sealed, self-contained, single use cassette
Security
Minimal risk of cross contamination
Password-protected user login
A Simple and fast test of latent tuberculosis infection
Latent TB in patients can develop into an active form with lethal transmissivity and proactive treatment is required. IGRA-TB is a unique product that combines a highly specific cell-mediated immune response (CMI) against MTB and a sensitive lateral flow detection system. It can help fight tuberculosis by detecting latent TB in the simplest, fastest, and most accurate way.
Assessing initial risk of bacterial infection and fatal sepsis
Early assessment of sepsis is critical in developing the treatment plan to improve the prognosis of the patient. The high sensitivity AFIAS PCT Plus test helps detection of the bacterial sepsis and the assessment of the risk of developing the septic shock.
A comprehensive menu including Adalimumab, Free anti- Adalimumab, Infliximab, Free anti- Infliximab, Total anti-Infliximab, Golimumab and Free anti-Golimumab. Menu will extend with additional parameters in the near future.
Fast results:
10 min for Drug Concentration: Infliximab / Adalimumab / Golimumab
~12 min for Free Anti-Drug Antibody Presence: Free Anti-Infliximab / Free Anti-Adalimumab / Free Anti-Golimumab
22 min for Total Anti-Drug Antibody Presence: Total Anti-Infliximab
The AFIAS-10 has a comprehensive panel of cardiac markers including Tn-T, Tn-I, BNP, NT-proBNP, hsCRP, STI, Myoglobin, D-Dimer, CK-MB and Cardiac Triple (Tn-I, CK-MB, Myoglobin).
Monitoring vitamin D deficiency & supplementation therapy
When abnormal calcium, phosphorus, and parathyroid hormone (PTH) levels are observed in a patient it is useful to check for association with vitamin D. Additionally, when starting drug treatment for bone disease, bone weakness, or osteoporosis, it is useful for diagnosis and monitoring of vitamin D prescription treatment.
Supporting diagnosis of viral and/or bacterial infection
MxA(Myxovirus resistance protein A) is an intracellular blood protein that mediates cellular resistance against a wide range of viruses and is elevated in the presence of most acute active viral infections. The level of CRP (C-reactive protein) increase in the wide status of inflammation and even more in bacterial infections. The MxA/CRP combo test assists in the diagnosis of viral & bacterial infections by measuring the virus-specific markers and CRP simultaneously.
All available parameters Infectious Diseases
Product code | Product Description | Package size |
56618 | IGRA-TB | 24 tests/ 8 samples |
51957 | CRP | 24 tests |
56825 | MxA/CRP | 24 tests |
52316 | IL-6 | 24 tests |
53699 | Procalcitonin Plus | 24 tests |
54427 | Norovirus | 24 tests |
54428 | Rotavirus | 24 tests |
54429 | Rota/Adenovirus | 24 tests |
51679 | COVID-19 Ab | 24 tests |
53710 | COVID-19 nAb | 24 tests |
53719 | Flu A+B | 24 tests |
51972 | COVID-19 Ag | 24 tests |
56619 | COVID-19 SP/NP IgG | 24 tests |
52317 | COVID-19/Flu Ag Combo | 24 tests |
Cardiac Markers
Product code | Product Description | Package size |
53231 | Tn-I Plus | 24 tests |
53232 | NT-proBNP | 24 tests |
53234 | D-Dimer | 24 tests |
54449 | ST2 | 24 tests |
55619 | Troponin T | 24 tests |
56818 | BNP | 24 tests |
56819 | hsCRP | 24 tests |
56820 | Cardiac Triple | 24 tests |
53688 | CK-MB | 24 tests |
53700 | Myoglobin | 24 tests |
Therapeutic Drug Monitoring
Product code | Product Description | Package size |
56629 | Adalimumab | 24 tests |
56630 | Infliximab | 24 tests |
56631 | Free anti-Infliximab | 24 tests |
56632 | Free anti-Adalimumab | 24 tests |
56832 | Total anti-Infliximab | 24 tests |
57192 | Golimumab | 24 tests |
Free anti-Golimumab | 24 tests | |
57182 | Ustekinumab | 24 tests |
57184 | Vedolizumab | 24 tests |
Hormones
Product code | Product Description | Package size |
53228 | TSH | 24 tests |
53230 | Testosterone | 24 tests |
53233 | TSH Plus | 24 tests |
53237 | ß-HCG Plus | 24 tests |
53693 | T3 | 24 tests |
53694 | T4 | 24 tests |
53696 | Cortisol | 24 tests |
53698 | Total ßhCG | 24 tests |
53701 | FSH | 24 tests |
53705 | LH plus | 24 tests |
53706 | AMH | 24 tests |
53709 | Prolactin | 24 tests |
56826 | Progesterone | 24 tests |
Other parameters
Product code | Product Description | Package size |
53229 | Ferritin | 24 tests |
56910 | Vitamin D Neo | 24 tests |
Autoimmune
Product code | Product Description | Package size |
53707 | Anti-CCP Plus | 24 tests |
56831 | Total IgE | 24 tests |
Cancer Markers
Product code | Product Description | Package size |
53695 | CEA | 24 tests |
53697 | AFP | 24 tests |
Diabetes
Product code | Product Description | Package size |
52934 | HbA1c | 24 tests |
52935 | Microalbumin | 24 tests |