A Word About Calibration; Purpose; General Procedure; Preparing A Fastpack Ip With A Calibrator Sample - Qualigen FastPack IP System Manuel

A Word about Calibration

Purpose

The purpose of this section is to concisely define how and when calibrators are run for the various assays
used in the FastPack IP System.
®

General Procedure

The calibration kit contains a calibration card and 1 vial of calibrator. The calibration card is used to
communicate to the analyzer that the next test run will be a calibration. Please follow these steps carefully:
Preparing a FastPack
1. Remove a FastPack
assay) and the operator's initials on the peel-off-label.
2. Gently invert the calibrator vial several times before drawing a sample from it. Inverting this
vial should be done each time you draw a sample.
3. Fill a FastPack
guide.

Preparing to Calibrate your Analyzer

1. Take the calibration card from the calibration kit.
2. Place the calibrator card in your analyzer by aligning the holes in the card with the pins in the
analyzer door.
3. Press the BLUE button.
4. The analyzer will read the calibration card information (~30 sec).
5. The analyzer should read "Insert Cal-Press Start".
6. Remove the calibration card.
Running the Calibrator FastPack
1.
Place the, calibrator filled, FastPack
2. The analyzer will process this pack and when complete, will display "Cal X Pass".
3. Remove the processed FastPack
4. Place the printed label onto the Label Record in the appropriate assay section of your Quality
Assurance Log.
5. Repeat the Calibration Procedure (The analyzer will display an alert when calibration is required.
See the Calibration Process Tree on Page 20 which illustrates the messages shown on the analyzer
display.).
6. Place the calibration card back into the Calibration Kit for storage.

When is Calibration Required?

The analyzer display will prompt you automatically when a calibration is due. This prompt will occur for
two reasons:

1. When Attempting to Use New Lots of FastPacks or Calibrators

2. When it's Time to Recalibrate

Calibration expires every 31 days for the following assays: Vitamin D, PSA, hCG, αGST, hsCRP
•
Calibration expires every 15 days for the following assays: TSH, Free T4, Testo
•
When either of these two scenarios occurs:
Run two calibrations for the following assays: TSH, FreeT4, PSA, Testo, hCG, αGST, hsCRP
•
Run three calibrations for the Vitamin D immunoassay
•
65000159 R ev. 0 07 ( 06/15) 1 9
IP with a Calibrator Sample
®
IP from the kit and write CAL 1 or CAL 2 (or CAL 3 for the Vitamin D
®
IP with the calibrator sample following the instructions found in your FastSteps
®
IP
®
IP into the analyzer and push the BLUE button.
®
IP from the analyzer and place in the printer.
®