QR CODE OF IFLASH REAGENT ITEMS

Document No. YHLO/MP-RD-005

Version/Ed. No. A / 19

Effective Date 2019-11-08

Distribution /

Security
Interior Use
Classification

Compilation

Approval
 Document No. YHLO/MP-RD-005
Version/Ed. No. A / 19
Effective Date 2019-11-08
QR Code of iFlash Reagent Items Pagination 1 / 20

Document Revise Record

Ed. No. Revise Content Revisor Effective Date

A/0 Initial delivery. Jianyou Mao 2016-12-15
1. Newly increased QR codes are the items: EB VCA IgG, Mycoplasma
pn. IgG, HSV-1 IgG, HSV-1 IgM, HSV-2 IgG, HSV-2 IgM, Anti-HCV,
A/1 Jianyou Mao 2017-4-5
HIV Combo, AFP, GADA, ICA, IA-2A, IAA.
2. Method of HBsAg ,AFP and HCG updated.
1. Revised the QR code of the 25-OH Vitamin D item.
2. Updated the method of the ANA 20170301 item.
A/2 Fang Bin 2017-4-18
3. Updated the measurement range of the E2 item.
4. Updated the measurement range of the Progesterone item.
1. Revised the QR codes of E2, SMA IgG, Troponin-I items.
2. Increased the QR codes of Anti-HBe, HBeAg, EB VCA IgG, EB
A/3 Fang Bin 2017-5-25
VCA IgM, EB VCA IgA, EB NA IgG, EB NA IgA, EB EA IgM and
Inhibin A items.
1. Revised the methods of E2, EB VCA IgG, EB VCA IgM, EB VCA
IgA, EB NA IgG, EB NA IgA, EB EA IgM, Mycoplasma pn. IgG,
AMH, free βHCG and dsDNA IgG items.
A/4 2. Revised the item codes of FQCW21 and FQCWD21. Fang Bin 2017-08-07
3. Increased the methods of Anti-HBc, Anti-HBs, CMV IgG, CMV
IgM, RA33 IgG, Rubella IgG, Rubella IgM, Toxo IgG, Toxo IgM,
Ferritin, CEA, Free PSA items.
1. Revised the item codes of HA, PⅢPN-P, Col Ⅳ and Laminin.
2. Increased the methods of β2-Glycoprotein I IgM, Chlamydia pn.
IgG, Chlamydia pn. IgM, CYFRA21-1, NSE, CA 125, CA 19-9 and
A/5 Total PSA. Fang Bin 2017-08-30
3. Formal methods of Cardiolipin IgA, β2-Glycoproterin I IgA, ZnT8A,
CA 15-3, Anti-TSHR, Vitamin B12, Folate and Adiponectin items will
not be released in this version.
Revised the lower limit of measurement range of the items CA 125,
A/6 CA 19-9, CYFRA21-1, NSE, Total PSA, Toxo IgG, CMV IgG, GADA Fang Bin 2017-09-18
and IA-2A.

Copyrighted by SHENZHEN YHLO BIOTECH CO., LTD. Security Classification: Interior Use
 Document No. YHLO/MP-RD-005
Version/Ed. No. A / 19
Effective Date 2019-11-08
QR Code of iFlash Reagent Items Pagination 2 / 20

1. Increased the methods of Adiponectin, Cardiolipin IgA,

β2-Glycoprotein I IgA.
2. Increased the Y1 version of universal diluents in the HCG item
method.
3. Revised the method of Troponin-I item (for Lot No.20171001and
A/7 the latter lots.). Fang Bin 2017-11-27
4. Revised the upper limit of measurement range read by iFlash
machine of the items ANA, SS-A IgG, SS-B IgG, Jo-1 IgG, Scl-70
IgG, Progesterone, E2, HCG, AMH, BNP, Anti-CCP, MPO IgG,
Anti-Tg, and dsDNA IgG.
5. Revised HBsAg and HIV Combo into special items.
1. Specified that this file is suitable to iFlash serial machine, including
iFlash 3000 Immunoassay Analyzer and iFlash 1800 Immunoassay
Analyzer.
A/8 2. Revised the on-board dilution ratio of HCG (Y1) and HBsAg (Y4). Fang Bin 2018-04-19
3. Updated the QR codes of ICA, SMA IgG, 25-OH Vitamin D, FT3
and T3 items.
4. Increased the QR codes of CA 15-3 and ZnT8A items.
1. Update the method in calibration mode of Anti-Tg、Anti-TPO、Toxo
IgG、Toxo IgM、Rubella IgG、EB NA IgG、Anti-CCP、EB VCA IgG
products.
A/9 2. Revise the lower test limit of Adiponectin; Fang Bin 2018-08-08
3. Add the accelerated method of HBsAg 、 HIV Combo (for
Lot.20180701 and after);
4. Add specific methods for internal QC (for unstable sample testing).
A/9.1 Add QR code for old version (use for international market) Fang Bin 2018-09-17

Update the QR codes of Anti-CCP (compatible with accelerated

A/10 software), HA (for Lot. 20180901 and after) and CMV IgG (for Lot. Zhisheng Xu 2018/1/18
20180901 and after).
Update the QR code of CMV IgM (for Lot.20181201 and after) and
A/11 Zhisheng Xu 2019/3/12
Toxo IgM (for Lot.20181201 and the after)
A/12 Update the QR code of CP IgG (for Lot. 20190501 and after) Zhisheng Xu 2019-4-1

A/13 Update the QR code of Toxo IgG (for Lot. 20190501 and after) Zhisheng Xu 2019-4-26

Update the QR code of β2-Gycoprotein I IgA (for Lot. 20190601 and

A/14 Zhisheng Xu 2019-8-2
after)
Add QR codes for Anti-TSHR/Folate/Folate II/Vitamin B12 II/25-OH
A/15 Zhisheng Xu 2019-8-6
Vitamin D II
A/16 Update the QR code for Cardiolipin IgA (for lot.20190701 and after) Zhisheng Xu 2019-8-28

Copyrighted by SHENZHEN YHLO BIOTECH CO., LTD. Security Classification: Interior Use
 Document No. YHLO/MP-RD-005
Version/Ed. No. A / 19
Effective Date 2019-11-08
QR Code of iFlash Reagent Items Pagination 3 / 20

A/17 Update the QR code for EB VCA IgM (for lot.20190801 and after) Jinghan Wang 2019-09-04

Update the QR code for HSV-1 IgM (for lot.20190801 and after)、CL 2019-09-24
A/18 Jinghan Wang
IgM(for lot.20190801 and after)
Update the QR code for ANA(for lot.20191002 and after)、CEA(for 2019-11-08
A/19 Jinghan Wang
lot.20191001 and after)

Expiry date after Corresponding

Universal Diluent Diluent ID
decap items

Sample Diluent B 1 28 days HCG

Sample Diluent E 4 28 days HBsAg

Copyrighted by SHENZHEN YHLO BIOTECH CO., LTD. Security Classification: Interior Use
 Document No. YHLO/MP-RD-005
Version/Ed. No. A / 19
Effective Date 2019-11-08
QR Code of iFlash Reagent Items Pagination 4 / 20

1 Objective
This document is used to specify the types and the usage of QR code.
2 Range of Application
This document applies to the production of iFlash reagents and analyzer machines, and to the instructions of
customer service.
3 Official Duty
Reagent R&D Center: in charge of renewing and updating this document.
Quality Management Department: in charge of releasing this document and controlling its versions.
4 Content
Range of application: applying to the production of iFlash reagents and analyzer machines, and to the instructions
of customer service.
Instructions: in the status of non-testing, Use code analyzer to scan the related QR code, making some addition or
revise according to the screenshot listed below.

Addition of New Method

Copyrighted by SHENZHEN YHLO BIOTECH CO., LTD. Security Classification: Interior Use
 Document No. YHLO/MP-RD-005
Version/Ed. No. A / 19
Effective Date 2019-11-08
QR Code of iFlash Reagent Items Pagination 5 / 20

Revise of Method

(Attention: it is inadmissible to delete the method of the item whose result has come out. Otherwise, the

existing result will disappear.)

Copyrighted by SHENZHEN YHLO BIOTECH CO., LTD. Security Classification: Interior Use
 Document No. YHLO/MP-RD-005
Version/Ed. No. A / 19
Effective Date 2019-11-08
QR Code of iFlash Reagent Items Pagination 6 / 20

5. Types of Items and QR Codes

Type of Autoimmunity

1、SLE (Systemic Lupus Erythematosus)

ANA ANA(for lots before 20191001) dsDNA IgG

2、SS (Sjogren's Syndrome)

SS-A IgG SS-B IgG Sm lgG

3、SSc (Systemic Sclerosis)

RNP70 IgG Jo-1 IgG Scl-70 IgG

Copyrighted by SHENZHEN YHLO BIOTECH CO., LTD. Security Classification: Interior Use
 Document No. YHLO/MP-RD-005
Version/Ed. No. A / 19
Effective Date 2019-11-08
QR Code of iFlash Reagent Items Pagination 7 / 20

4、ALD (Autoimmune Liver Disease)

AMA-M2 SMA IgG

5、RA (Rheumatoid Arthritis)

RF lgG RF IgM RF

Anti-CCP RA33 IgG

Copyrighted by SHENZHEN YHLO BIOTECH CO., LTD. Security Classification: Interior Use
 Document No. YHLO/MP-RD-005
Version/Ed. No. A / 19
Effective Date 2019-11-08
QR Code of iFlash Reagent Items Pagination 8 / 20

6、AAV (Autoimmune Vasculitis)

MPO IgG PR3 IgG GBM IgG

7、APS (Antiphospholipid Antibody Syndrome)

Cardiolipin IgM(for lots Cardiolipin IgM(for Cardiolipin IgA (for lots Cardiolipin IgA (for
before 20190801) lot.20190801 and after) before 20190701) lot.20190701 and after)

Anti-Cardiolipin β2-Glycoprotein I IgG β2-Gycoprotein I IgA (for β2-Gycoprotein I IgA (for

lots before 20190601) lot. 20190601 and after)

Anti-β2-Glycoprotein I β2-Gycoprotein I IgM Cardiolipin IgG

Copyrighted by SHENZHEN YHLO BIOTECH CO., LTD. Security Classification: Interior Use
 Document No. YHLO/MP-RD-005
Version/Ed. No. A / 19
Effective Date 2019-11-08
QR Code of iFlash Reagent Items Pagination 9 / 20

8、Diabetes

GADA IAA IA-2A ZnT8A

Insulin C-Peptide ICA

9、Performance Test of Machines

Two-Step Method 1 of Dilution Method 1 of

Performance Test Performance Test
FQCW21 FQCWD21

Copyrighted by SHENZHEN YHLO BIOTECH CO., LTD. Security Classification: Interior Use
 Document No. YHLO/MP-RD-005
Version/Ed. No. A / 19
Effective Date 2019-11-08
QR Code of iFlash Reagent Items Pagination 10 / 20

Other Regular Testing Items

10、 Thyroid

Anti-TPO FT3 Anti-Tg

TSH T3 Tg

FT4 T4 Anti-TSHR

Copyrighted by SHENZHEN YHLO BIOTECH CO., LTD. Security Classification: Interior Use
 Document No. YHLO/MP-RD-005
Version/Ed. No. A / 19
Effective Date 2019-11-08
QR Code of iFlash Reagent Items Pagination 11 / 20

11、Fertility

AMH E2 FSH HCG

Inhibin B LH Progesterone Prolactin

Testosterone DHEA-S Inhibin A

Copyrighted by SHENZHEN YHLO BIOTECH CO., LTD. Security Classification: Interior Use
 Document No. YHLO/MP-RD-005
Version/Ed. No. A / 19
Effective Date 2019-11-08
QR Code of iFlash Reagent Items Pagination 12 / 20

12、Tumor Markers

PG1 PG2 Free PSA CEA

CYFRA21-1 NSE TPSA CEA (for lots before

20191001)

CA125 CA15-3 CA19-9

Copyrighted by SHENZHEN YHLO BIOTECH CO., LTD. Security Classification: Interior Use
 Document No. YHLO/MP-RD-005
Version/Ed. No. A / 19
Effective Date 2019-11-08
QR Code of iFlash Reagent Items Pagination 13 / 20

13、Vitamin

25-OH Vitamin D 25-OH Vitamin D II

14、 Cardiac Markers

BNP CK-MB Troponin-I

Myoglobin

Copyrighted by SHENZHEN YHLO BIOTECH CO., LTD. Security Classification: Interior Use
 Document No. YHLO/MP-RD-005
Version/Ed. No. A / 19
Effective Date 2019-11-08
QR Code of iFlash Reagent Items Pagination 14 / 20

15、Fibrosis Liver

HA (for lots before PⅢP-NP CoI Ⅳ LN

20180901)

HA (for Lot. 20180901

and after)

16、Down's syndrome;

PAPP-A free βhCG uE3 AFP

Copyrighted by SHENZHEN YHLO BIOTECH CO., LTD. Security Classification: Interior Use
 Document No. YHLO/MP-RD-005
Version/Ed. No. A / 19
Effective Date 2019-11-08
QR Code of iFlash Reagent Items Pagination 15 / 20

17、Adrenaline

Cortisol ACTH

18、 Others

PCT PTH Ferritin Adiponectin

Copyrighted by SHENZHEN YHLO BIOTECH CO., LTD. Security Classification: Interior Use
 Document No. YHLO/MP-RD-005
Version/Ed. No. A / 19
Effective Date 2019-11-08
QR Code of iFlash Reagent Items Pagination 16 / 20

Type of Infectious Diseases

19、Preoperative

HBsAg HIV Combo Anti-HBe

HBeAg Anti-HBs Anti-HBc

Anti-HCV Anti-TP

Copyrighted by SHENZHEN YHLO BIOTECH CO., LTD. Security Classification: Interior Use
 Document No. YHLO/MP-RD-005
Version/Ed. No. A / 19
Effective Date 2019-11-08
QR Code of iFlash Reagent Items Pagination 17 / 20

20、Epstein-barr virus

EB EA IgM EB NA IgA EB NA IgG EB VCA IgG

EB VCA IgM（for lots EB VCA IgM（for Lot. EB VCA IgA

before Lot. 20190801） 20190801 and after）

Copyrighted by SHENZHEN YHLO BIOTECH CO., LTD. Security Classification: Interior Use
 Document No. YHLO/MP-RD-005
Version/Ed. No. A / 19
Effective Date 2019-11-08
QR Code of iFlash Reagent Items Pagination 18 / 20

21、Respiratory pathogens

Chlamydia pn. IgG (for Chlamydia pn. IgG(for

Mycoplasma pn. IgG Mycoplasma pn. IgM
lots before 20190501) Lot. 20190501and after)

Chlamydia pn. IgM

Copyrighted by SHENZHEN YHLO BIOTECH CO., LTD. Security Classification: Interior Use
 Document No. YHLO/MP-RD-005
Version/Ed. No. A / 19
Effective Date 2019-11-08
QR Code of iFlash Reagent Items Pagination 19 / 20

22、TORCH

HSV-1 IgM((for lots HSV-1 IgM(for Lot.

HSV-1 IgG HSV-2 IgM
before 20190801） 20190801and after）

Toxo IgG （for lots before Toxo IgG (for lot.

Rubella IgM Rubella IgG
20190501） 20190501 and after)

Toxo IgM（for lots before Toxo IgM（for CMV IgM (for lots CMV IgM (for

20181201） Lot.20181201 and after） before 20181201) Lot.20181201 and after)

Copyrighted by SHENZHEN YHLO BIOTECH CO., LTD. Security Classification: Interior Use
 Document No. YHLO/MP-RD-005
Version/Ed. No. A / 19
Effective Date 2019-11-08
QR Code of iFlash Reagent Items Pagination 20 / 20

CMV IgG CMV IgG (for HSV-2 IgG

Lot.20180901 and after)

23. Anemia

Folate Folate II Vitamin B12 II

Copyrighted by SHENZHEN YHLO BIOTECH CO., LTD. Security Classification: Interior Use