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AFIAS-10

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. AFIAS-10 is a cost-effective solution. 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
  • Wide range sampling options (automatic from primary tube, pipette)
  • 10 parallel tests at the same time
FAST
  • Minimal manual hands-on with ready to use All-in One cartridges and ID chip calibration
  • Minimal sample preparation required
  • 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 required with the All-in One cartridge system
  • No manual calibration with ID chip
  • Room temperture storage
  • Bi-directional LIS and HIS minimises manual handling
COST-EFFICIENT
  • High throughput: up to 12 patients/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 (3 per patient, 8 patients per kit)

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

 

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 for IGRA TB Testing.


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

Each bay can be operated separately

10 different tests in parallel or 10 samples with the same test


Throughput

12 patients/hour


SAMPLE TYPES AND SAMPLING OPTIONS

Sample AIFAS-10 IGRA TB Tubes 

Blood collection tube (0.5 & 3.0 & 5 ml)

Microcentrifuge tube (0.5 & 1.5 ml)


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.

Evaluation of a lateral flow assay–based IFN-release assay as a point-of-care test for the diagnosis of latent tuberculosis infection