IFU-iax2101-EN

IAX-2101

2023 - MAR 09

iaX-2101 (intelligent analyzer eXpress) - Instructions For Use (IFU)

This product may be used for Clinical Laboratory (CL), Point Of Care (POC) or Point Of Entry Testing (POET). Currently this product is NOT intended for Home Use

Intended Use

This product can read qualified Lateral Flow Immunochromatographic and Immunofluorescence assays.

Overview

This product can analyze various types of test cassettes from various suppliers. A barcode or QR code on the test cassette is used to identify the supplier and the specific test type inserted. Please visit http://www.utid.org for the latest list of tests that are supported. Be sure to carefully read the Instructions For Use (IFU) of the test you are using

Security And Privacy

This product does not store test or patient data on the device itself, because the data is only temporarily buffered on the device and then uploaded to the cloud when it is available to connect to the Internet. Each test is only tracked through a unique serialized barcode.

Please note that the type and brand of test kits may vary. The operator should always make sure to read and follow the instructions and documentation for the specific test to be performed, including collecting test samples and preparing samples for analysis by this product.

This product test kit is only used for in vitro diagnostics and can only be used by qualified personnel who have read and understood this manual and have received appropriate training regarding the use and operation of this product.

Important:

Complete instruction manual
Please visit www.apollo.bio to download the complete instruction manual. Available in multiple languages.

Qualified lateral flow analysis
Only read lateral flow measurement methods that have been approved by this product. Please visit http://www.utid.org to view the latest list of lateral flow assays eligible for use with this product.

List of symbols on the device labels
Please reference the ISO 15223-1 Medical Devices

Adverse events
Use this link to report any anomalies:
https://assaya.com/ae
If a user has encountered any serious incident in relation to the device, the incidents shall be reported to the manufacture and the competent authority of the Member State in which the user and/or the patient is established.

Power

First, attach the power cord from the power adapter to the power connection port in the rear of the iaX and secure tightly by twisting the power connector until locked.

Internet Connection

The iaX requires an Internet connection to communicate with the Cloud. There are two ways to connect that can be used simultaneously for redundancy.

LAN (Local Area Network)

Attach the RJ-45 connector to a router with internet connectivity, and observe that the LED lights are lit or flashing.

WiFi

The iaX also has built in 802.11 wireless networking connectivity. To utilize this feature an access-point must be configured with the following credentials:

SSID: Assaya

Passphrase: 88888888

Status Indicators

The iaX has LEDs that shows the status of the device during operation. This figure shows the indicators and their functions.

Sterilization

A special carrier or test cassette is installed to start the 275 nm UV cycle. The length of the UV is indicated by the barcode of the cassette. Contact Apollo to purchase this item.

Power Button Status

First, attach the power cord and the power adapter to the power port in the rear of the iaX and secure tightly by twisting the power connector until locked.

OFF

Power is OFF. Press button to turn on.

Blue Blink:

Device is booting, please wait.

Blue Steady:

Device Ready.

Red Blink:

Hardware Error, Needs Service.

Red ON:

Network connection problem.

If you have a network problem, you can still use the iaX to read tests,
but reporting may be delayed until you are reconnected.

Result Indicators

GREEN – (NEGATIVE)

YELLOW ! (INVALID)

RED + (POSITIVE)

Invalid Result (Yellow ! LED)

The cause of this can be:

The test medium shows invalid result where a Control Line did not develop
There is physical or visual damage to the test medium
The barcode of the test medium is invalid or damaged

A flashing Yellow LED indicate a test profile that the iaX is not yet supporting. Contact Apollo support for software upgrade.

Performing Tests

Tests are read automatically after insertion. For cassette type LFAs, insert the cassette as shown from the front and fully into the reader. Then wait for the result. Result times may vary depending on the complexity of the assay. If no result is shown within approx. 5 seconds, remove the cassette and repeat the procedure.

Theory Of Operation

The iaX is a compact computer vision system comprising a camera, multi color LEDs with diffusers and a compute analytics unit comprising a CPU and GPU. The LEDs illuminate the sample, and provide a consistent light environment to ensure accurate analysis of samples. The LEDs contain a variety of colors and wavelengths, including non-visible IR and UV light that are needed to surpass the reading capabilities of human eyes.

Block Diagram

The illustration below shows a simplified block diagram of the main components of the iaX.

Reagents with different concentrations of N-protein 1-10 mg under a certain light source will show different intensities of reading lines. Under VIS, UVA or UVB irradiation, the reaction reading color lines will show strong or weak data values. The sensitivity and specificity is obtained at the interpretation value of the reagent’s LOD according to the recommendations of the U.S. Food and Drug Administration, depending on if the reading value is below the negative value and above the positive value.

Setup

This product analyzes the settings of the LOD reading value of the reagents for each manufacturer according to the above method, and the Barcode/QR code is used for identification. Many test kits are based on interpretation by human eye, which if often inaccurate due to external factors. This instrument can greatly reduce human errors, and improve the status of accurate interpretation.

Supported Cassette Types

The iaX, with its standard carrier, supports a wide variety of cassette and card type Lateral Flow Assays. The iaX requires that all test-kits must follow the system specifications for type.

Reproducibility and Consistency of Results

As the iaX can support many Cassette Types, it is important to demonstrate consistent reading of results for various concentrations if the same test is inserted many times even at different physical angles.

Test Data Performance

With reference to the US Food and Drug Administration, the supplier’s test kit was developed using N-Protein based on the supplier’s IFU, and it was read 5 times by this product and visually read by 5 different operators.

Using various concentrations of N-protein as a control, accurate and reproducible results can be obtained to confirm sensitivity and specific values.

The study followed the recommendations of the U.S. Food and Drug Administration’s references:

Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests – Guidance for Industry and FDA Staff

Calibration

Every iaX has undergone functional testing and calibration at the factory, and performs an automatic self test on every powerup.

Functional Test Cassette

The Functional Test Cassette that comes with the kit shall be inserted at least once for every 10,000 tests to ensure that the analyzer is working properly. Please store the cassette properly so that it does not get wet, scratched or otherwise damaged.

If the Functional Test Cassette causes the green result LED to light, the iaX is working properly and can continue to be used. If the red result LED lights up when the Functional test Cassette is inserted, the iaX must be serviced and it should no longer be used for analysis or testing.

Technical Support

Email: support@assaya.com

Adverse Events Reporting

Use this link to report any adverse events: assaya.com/ae

Ordering Information

Catalog Number (REF): IAX-2101

1 pcs per box

Manufacturer

iaX