QF254.04（3.

0）

Application News
Subject: Toxo IgG optimized version reagent kit launched.

RECORD IDENTIFIER

Ref No.: ACLIA-23020-Toxo IgG (V1.0) Relate To:

Version:1.0 Software/Manual Upgrade
Author: Jin Lu Reagent Change
Date: 2023-11-22 Control Target Value Change
Model: Toxo IgG Calibrator Target Value Change
Comments: / Application Parameter Change
Stop Production
Others

CONTENT

To Whom It May Concern,

Hello!
To optimize the performance of Mindray immunoassay systems, Mindray continues to improve the

reagent quality to guarantee better results. The following is the announcement of Toxo IgG optimized

version reagent kit launched.

Product
Product Name Catalog No. Package Size
105-012524-00 2×50 tests (calibrators not included)
105-012525-00 2×100 tests (calibrators not included)
Toxoplasma gondii IgG（CLIA）
105-012527-00 2×50 tests (calibrators included)
105-012528-00 2×100 tests (calibrators included)

Definition
Optimized Toxo IgG reagent: starting from Lot#20230801

Change Points
⚫ Improve the anti-interference capability and reduce the probability of abnormal results. The main

changes of the product performance are as following：

Performance Current version Optimized version
Consistency In the internal evaluation experiment, the In the internal evaluation experiment, the
rate* consistency rate with DiaSorin: Negative consistency rate with DiaSorin: Negative

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consistency rate: 97.50% (585/600); consistency rate: 99.83% (605/606);

Positive consistency rate: 95.91% Positive consistency rate: 100%
(97/98) (103/103)
*
Representative data. The results of different laboratories may vary.
⚫ There are 3 barcodes in the optimized version of the reagent kit. Please scan them one by one into

the system.

Control (Mindray)
⚫ The test results of Mindray ToRCH IgG Positive Control are different between optimized and
current versions reagent. *Mindray target values are shown in the table below.
Toxo IgG result of Toxo IgG result of
Control Lot No.
current version reagent optimized version reagent
ToRCH IgG Positive 20230501 23.26 IU/mL 18.01 IU/mL
Control 20230701 23.19 IU/mL 18.26 IU/mL
*
Representative data. The results of different laboratories may vary.
⚫ The optimized version reagent contains the target value list of Mindray controls until the
above-mentioned controls are all expired. When using the new version reagent, you can refer
to the target value list or re-accumulate target values. Please pay attention.
⚫ In the Mindray ToRCH IgG Positive Control manufactured after August 2023, two target value
sheets for the current and optimized Toxo IgG reagents respectively will be placed in the
control kit until the last lot of current reagent (Lot#20230401) is expired. Please use the correct
target value and barcode.

If you need to download information or have any question, please feel free to contact Mindray
regional application specialist or Mindray Service Department. (email:service@mindray.com).

Thank you for your kind attention and cooperation.

Sincerely yours,
Mindray Service Department
Mindray Co., Ltd.

Application News Revision

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Version Effective Date Description

1.0 2023-11-22 Document released.

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