Menarini Diagnostics Svezia > Hem > Diagnostikprodukter för vården > Immunkemi

Menu

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
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

IGRA-TB

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.

Procalcitonin (PCT) Plus

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.

Therapeutic drug monitoring

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

Cardiac Markers

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).

Vitamin D Neo

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.

MxA/CRP

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

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

Brochure available here:

Measurement principle

AFIAS Cartridge

AFIAS-10 system technical specification

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

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

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

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

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

Våra värderingar