Italy

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, 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:

Measurement principle

See AFIAS Menarini Diagnostics > Home > Professional Diagnostics > COVID-19 > Antibody Detection > The AFIAS Range of POCT Analysers > Technical data

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

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

Link to publication

Analytical performances of a novel point-of-care procalcitonin assay  

Link to publication

Level of follicular fluid vitamin D and embryo quality in a sample of Iraqi women undergoing IVF  

Link to publication

An assessment of automated Vitamin D measurement methods including a Point of Care Testing method, Boditech i-CHROMA™ using the (RIQAS)  

Link to publication

Evaluation of fluorescence hs-CRP immunoassay for point-of-care testing

Link to publication

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