France

1. RAPID AUTOMATED RESULTS YOU CAN TRUST

- Minimal hands-on time for specimen preparation (1 min)

- Test results in as little as 30 minutes*

- Read on-screen results, optionally view curves

- Multiplex capability using microfluidics to perform rapid, six channel PCR testing in real-time

- Built-in quality control


2. EASY TO USE SYSTEM

- Tests are simple to perform, using easy to follow guided workflows

- Simple, intuitive, software available in local languages

- Large, responsive 7 inch wide-screen touch display

- No calibration required and mimimal user maintenance (air filter)


3. CLOSED AND SAFE SYSTEM

- Reduced contamination risk

- Fully sealed cassettes

- Reagents integrated into the test cassettes

- Integrated barcode scanner toidentify test cassettes and initiates the test run process


4. FLEXIBILITY AND CONNECTIVITY

- Small footprint ( W 24cm x D 30cm x H 20cm ) and weights less than 8kg

- Multiple connectivity options: LIS, LAN, 3G, 4G and WiFi

- Mains operated system with internal battery (five runs on a full charge)

- Seamless transition between mains and battery in the event of a power disruption



PRINCIPLE OF OPERATION

The Q-POC™ is compatible with single-use QuantuMDx test cassettes and possesses the ability to manipulate fluid and generate the conditions required to perform polymerase chain reaction (PCR) and report qualitative fluorescence signal data. The instrument is designed to be easy to use and require minimal instrument maintenance or operator training.

The general Q-POC™ testing workflow consists of five (5) main operator steps:


Q-POC is available in the following A.Menarini Diagnostics countries:

France: https://www.menarinidiagnostics.fr

UK: https://www.menarinidiag.co.uk


Q-POC™ system technical specification 

 

Intended use

The QuantuMDx Q-POC™ is an automated, molecular instrument designed to process single-use, disposable test cassettes for the detection and/or, differentiation of targeted nucleic acid sequences. The instrument is intended for the in vitro examination of specimens (e.g. derived from the human body or synthetic). The Q-POC™ is designed for use in a Point of Care or Laboratory environment including field or mobile settings

PHYSICAL PROPERTIES

Dimensions (W x H x D)

Weight

Operating languages

Memory storage

24 x 20 x 30cm

<8 kg

Multilingual

internal SSD memory

Analysis method

Sample preparation Direct-to-PCR Amplification & detection Qualitative RT-PCR

FUNCTIONAL SPECIFICATIONS

Fluorescence

Light source

Temperature hold accuracy

Temperature accuracy

Optics

6 detection channels

Light Emitting Diodes (LED)

± 0.15°C for hold times up to 1 hour

± 0.25°C

AF350, FAM, HEX, ROX, CY50, AF750

MAINTENANCE

Calibration

Maintenance

Power saving

None required

Periodic fan filter change only

Auto-sleep

SAFETY

Cross contamination

Security

Sealed, self-contained, single use cassette, Minimal risk of cross contamination

Security Automatic and manual screen lock options, Password-protected user login

OPERATIONAL CONDITIONS

Temperature

Relative humidity

Altitude

Orientation

Atmospheric

5 – 45 °C

Up to 95% relative humidity (non-condensing)

-500 meters to 2000 meters above sea level*

= 5 degrees from horizontal – any direction

0.76 – 1.03 Bar (76 – 103 kPa)

ELECTRICAL SPECIFICATIONS

Power requirements

Battery life

Internal battery

Power mode

100 – 240 Vac; 50 – 60 Hz; 19 Vdc; < 4.74 A

Up to 5 test runs

Lithium ion; 6900mAh; 99.4Wh capacity

Seamless transition between mains and battery, in event of power disruption

USER INTERFACE

Interactive display

Display resolution

Barcode reader (integrated)

Data export

LIS integration

Audible alert

Printer

7-inch-wide super VGA LCD colour touch display with LED backlighting

1024 x 600 pixels

Supports Data Matrix (ECC200)

2x USB 2.0 port Ethernet Wi-fi

Unidirectional communications via Ethernet network or WiFi connection

<70dBa at 1 m

Optional Bluetooth thermal printer available


Tipping point product demo


 

Q-POC system brochure

Q-POC use cases brochure

Q-POC SARS-CoV-2 ASSAY brochure

Q-POC SARS-CoV-2, Flu AB & RSV Assay brochure

Robust detection of SARS-CoV-2 in a multi-centre evaluation of clinical performance using the QuantuMDx SARS-CoV-2 RT-PCR Detection Assay

The QuantuMDx SARS-CoV-2 RT-PCR Detection Assay has demonstrated excellent clinical performance across 5 external validation sites with positive and negative percent agreement of 99.0% and 100% respectively. 

A rapid extraction-free methodology for detection of SARS-CoV-2 using the QuantuMDx SARS-CoV-2 RT-PCR Detection Assay for use in the screening of single/pooled saliva samples

QuantuMDx have optimized a methodology for detecting SARS-CoV-2 in saliva specimens without the need for extraction/swabs using commercially available SARS-CoV-2 RT-PCR Detection Assay product. The methodology cuts the time to result to <125 minutes…

Item

Description

Pack size

56868

Q-POC THERMAL PRINT.Q14-005-T01

1

56869

Q-POC SARS-COV-2 CTRL Q04-018

1

56870

Q-POC SARS-COV-2 ASSAY FR Q27001 20 tests

20

56871

Q-POC SARS-COV-2 ASSAY UK Q27001 20 tests

20

56872

PIPETTE TIPS 20UL Q15-004-P01

96

56873

PIPETTE TIPS 1ML Q15-003-P01

100

56874

Q-POC INSTRUMENT Q29001

1

56875

PIPETTE FIX VOL 400 Q15-001-P01

1

56876

PIPETTE FIX VOL 20 Q15-002-P01

1

56877

MSWAB KIT 3ML&FLOQSW.Q14-116-P02 50 tests

50

56878

Q-POC RESP.RSV ASSAY Q04-017 20 tests

20

The Q-POC™ Severe Acute Respiratory Syndrome Virus Coronavirus-2 (SARS-CoV-2) Assay is a qualitative, real-time reverse transcription polymerase chain reaction (rtRT-PCR) assay for the detection of SARS-CoV-2 genomic RNA from upper respiratory specimens (e.g. nasal mid-turbinate swabs) collected from individuals who meet criteria for SARS-CoV-2 testing. The Q-POC™ SARS-CoV-2 Assay is a qualitative assay. The Q-POC™ SARS-CoV-2 Assay test cassette contains lyophilised reagents comprised of all components required for rtRT-PCR amplification and detection of genomic RNA from SARSCoV-2 virus, a Specimen Process Control (SPC) and a reagent Rehydration Control.

 

Assay specifications:

  • Specimen: Nasal mid-turbinate
  • Time to results: 30 min
  • Hands-on time: 1 min
  • LoD: 50 copies/rxn
  • Targets: SARS-CoV-2 Orf1, N and S genes
  • Store: Collection kits and cassettes at 0-25°C
  • Control: Sample process control and rehydration control
  • External control: Q-POC™ SARS-CoV-2 Controls

 

The Q-POC SARS-CoV-2, Flu A/B & RSV Assay is a single-use disposable test cassette to be processed by the Q-POC instrument to result in rapid automated qualitative real-time reverse transcriptase-polymerase chain reaction (rtRTPCR) for the detection and differentiation of SARS-CoV-2, influenza A, influenza B and RSV genomic RNA from nasal mid-turbinate, and nose and throat, specimens collected from individuals suspected of respiratory viral infection by their healthcare provider

The Q-POC SARS-CoV-2, Flu A/B & RSV Assay is run on the Q-POC instrument, automating nucleic acid release, amplification and detection of nucleic acid from biological samples. The qualitative rtRT-PCR assay targets the Orf1, N and S genes of SARS-CoV-2, the matrix protein of Flu A, the nonstructural protein of Flu B, and the nucleoprotein and matrix protein of RSV, well conserved regions of the viruses. It also runs a Specimen Process Control (SPC) to ensure sufficient sample collection and proper functioning of the test.

 

Assay specifications:

  • Specimen: mid-nasal or nose & throat sample
  • Hands-on time: 1 min
  • Time to results: 35 min
  • LoD: SARS-CoV-2: 250 copies/ml Flu A: 1000 copies/ml Flu B: 1250 copies/ml RSV A: 4000 copies/ml RSV B:1500 copies/ml
  • Targets: SARS-CoV-2: Orf1, N and S genes Flu A Matrix protein Flu B Nonstructural protein RSV Nucleoprotein; matrix protein
  • Store: Collection kits and cassettes at 0-25°C
  • Control: Specimen Process Control
  • External control: Q-POC™ SARS-CoV-2 Controls

The Q-POC™ SARS-CoV-2 Positive and Negative Controls have been formulated for use with the QuantuMDx Q-POC™ System consisting of the Q-POC™ instrument and Q-POC™ SARS-CoV-2 Assay disposable test cassette. The Q-POC™ SARS-CoV-2 Positive Control consists of purified intact viral particles(Isolate: USA-WA1/2020) which have been chemically treated to render them non-viable, and human A549 cells. The Q-POC™ SARS-CoV-2 Negative Control contains purified human A549 cells. The control pack contains 1 x 250 µL vials of each Q-POC™ SARS-CoV-2 Positive and Negative control.

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