Afinion AS100 User Manual

Anion
TM
ACR
Quick Guide
1
Important!
• Read the entire Anion™ ACR Quick Guide before testing patient samples or controls.
• See the Anion™ AS100 Analyzer User Manual for more information about the operation of the Analyzer
and Test Cartridge.
• See the Anion™ ACR Package Insert for more information about the ACR assay.
• Use quality control materials to conrm that the Analyzer and test kit are working properly.
Anion™ AS100 Analyzer
1 ON/OFF button
2 Light emitting diodes
3 Touch screen
4 The lid
5 Connectors
Cleaning the Analyzer
Clean the Analyzer every 30 days.
Follow the procedure in the User
Manual. See section “Cleaning and
Maintenance”.
Important Touch Buttons
Patient sample mode
Control mode
Patient ID
Control ID
Enter
Accept
Afinion™ ACR Test Cartridge
Important Information Codes
Code Cause
107 Creatine too high
108 Blood in the urine detected by the Analyzer*
213 Test Cartridge or Analyzer failure
* see Anion™ ACR Package Insert
Getting Started
Take time to familiarize yourself with the Analyzer and the test kit.
1
2
3
4
5
Sampling device
Barcode
Capillary
ID area
1
Symbol Cause/Explanation
Albumin: < 5.0 mg/L The albumin concentration is below 5.0 mg/L
Albumin: > 200.0 mg/L The albumin concentration is above 200.0 mg/L
Creatinine: < 16.4 mg/dL The creatinine concentration is below 16.4 mg/dL
Creatinine: > 339.9 mg/dL The creatinine concentration is above 339.9 mg/dL
ACR: — — — The ACR value cannot be calculated as the albumin or creatinine value is outside range.
If the patient’s albumin and/or creatinine value is outside the reportable range, one or two of the messages in the list below will be
displayed. In this case an ACR test result will not be reported, and the last message listed below (ACR: - - -) will be displayed.

Afinion AS100 Specifications

General

Type	Point-of-care analyzer
Power Requirements	100-240 V AC, 50/60 Hz
Intended Use	In vitro diagnostic use
Measurement Parameters	HbA1c, ACR, CRP
Analytes	HbA1c, CRP, ACR
Sample Type	Whole blood, urine
Measurement Principle	Immunoassay, enzymatic assay
Calibration	Automatic calibration
Operating Temperature	15 to 30°C
Connectivity	USB, Ethernet, RS-232
Display	Color touchscreen
Measurement Time	3-6 minutes depending on test
Humidity Range	10-85% relative humidity, non-condensing

Summary

Getting Started with Afinion AS100 Analyzer

Afinion AS100 Analyzer Overview

Details the components of the Afinion AS100 Analyzer, including the ON/OFF button, touch screen, and connectors.

Analyzer Cleaning Procedure

Instructions for cleaning the Afinion Analyzer every 30 days, referring to the User Manual for details.

Prepare for Testing and Sample Collection

Prepare for Testing Steps

Steps to prepare the Afinion Analyzer and Test Cartridge, including powering on and reaching operating temperature.

Control Vial Sample Collection

Guidance on collecting samples from a control vial for testing with the Afinion ACR system.

Urine Cup Sample Collection

Instructions for collecting patient samples from a urine cup using gloves and proper mixing techniques.

Test Cartridge Specimen Collection

Step-by-step visual guide on how to collect a sample using the Afinion ACR Test Cartridge.

Running Samples and Verification

Running Patient Samples

Procedure for running patient samples on the Afinion Analyzer, including inserting the cartridge and entering patient ID.

Running Controls

Procedure for running control samples on the Afinion Analyzer, including inserting the cartridge and entering control ID.

Information Codes and Result Verification

Explanation of information codes and verification steps for test and control results.

Control Testing Procedures and Troubleshooting

Control Testing Frequency

Guidelines on how often Afinion ACR controls should be run, including frequency based on kit usage and test results.

Using Afinion ACR Controls

Instructions for using Afinion ACR controls, including sample mixing and comparison with package insert values.

Handling Out-of-Range Control Results

Steps to take when Afinion ACR control results are not within the acceptable range, including re-testing and contacting support.