Who we are
We are a vertically integrated company with R&D, manufacturing and commercial sales.We are a national hi-tech enterprise and CE certified. We have bulit ourself-owned core technologies with Ingenuity,and realized mass production of QDs diagnostic reagents with an annual output of over 2 million aliquots for the first time nationwide upgrading and promoting QDs tech.,we improved the precision of the chromatographic methodology to within 10% for the first time,making it the first IVD company to achieve the "pg" detection level using the chromatographic method in our country.
In the future, we will advance with time and continue to focus on the R&D of QDs technologies.
人才是企业的引擎
质量是企业立足的基石
客户是企业发展的伙伴
资本是企业腾飞的翅膀
开放合作,拥抱未来
争做最优秀的诊断试剂企业
打造最先进的体外检测平台
为社会提供精准检测
为客户提供优质服务
回报股东信任
助力个人发展
提供就业岗位
传播先进知识
传承中华美德
人才是企业的引擎
质量是企业立足的基石
客户是企业发展的伙伴
资本是企业腾飞的翅膀
开放合作,拥抱未来
争做最优秀的诊断试剂企业
打造最先进的体外检测平台
为社会提供精准检测
为客户提供优质服务
回报股东信任
助力个人发展
提供就业岗位
传播先进知识
传承中华美德
News
Development path
Professor Louis E. Brus first proposed the concept of colloidal quantum dots.
Professor Moungi G. Bawendi successfully synthesized quantum dots for the first time.
Jin Zhun quasi-quantum dots in Shenzhen love medical began to hatch.
Jin Zhun biological quantum point and students!
Quantum dot material Beidou system development platform, handheld instrument shock market.
R&D platform founded to make series of quantum dot material and put forward the new concept of whole-process quality control.
CE certified
Honor
CE-EN ISO13485
RIQAS 2018 PCT Certification
NCCL 2018 PCT Certification
Immunofluorescence quantitative analyzer
Procalcitonin quantitative assay kit (QDs immunofluorescence assay)
Member of Shenzhen Association of Medical Devices(2015)
Method for labeling immune globulin by quantum dots
Quantum dots labeled protein chip kit and preparation method
Immunitychromatography test card
Packing carton (Kingfocus quantum dots diagnostic reagent)
Immunofluorescence quantitative analyzer
Micro reaction chamber structure
Protein chip
CRP/PCT (C-reactive protein/procalcitonin) combined diagnosis test paper
Member of Shenzhen Medical Devices Quality Association
Member of Shenzhen Association of Medical Devices(2016)
Jointly diagnose test strip subassembly
Social responsibilities
Kingfocus Biomedical insists on developing rapid clinical diagnostic reagents based on QDs technologies.
Aiming to create the world's leading domestic brand,which features higher sensitivity, better accuracy, wider linear range, and more convenient operation,
To write a new chapter for human health!
hr@king-focus.cn微信公众平台
官网二维码
New concept of Whole-process quality control
1.concept description
Quality Control is a general concept that can be applied in any field. For clinical laboratory medicine,Quality Control is the guarantee and premise to obtain true value,and to evaluate the precision, accuracy and stability of the whole test system.
2. why clinical medicine requires quality control:
(1)The traceability and precision of the test system.
(2)Accuracy of measurement results.
(3)Comparable results.
I. Raw Materials: our Beidou QDs system (arranged in four rows)
Description:
1.QDs Fluorescence diagram and Absorption spectrogram:
(1)FWHM:It is normally between 35nm and 38nm, and is less than 40nm. We can achieve 34nm with exclusive technology.
(2)Absorption peak:The fact that the first exciton peak of Absorption spectrogram(blue) be sharp will indicate a great uniformity of QDs.
2. Transmission electron microscopy:QDs have a great uniformity.
3. Our QDs:highly-productive raw material (5g QDs for 20 million reagent cards). The productivity and inter-batch variation of raw material are of great significance to the inter-batch variation and stability of reagents.
II.Production Quality Control:With the whole-process barcode inspection, poor-quality reagent strip/test card can be automatically identified and eliminated.The automatic equipment in replacement of manual full inspection can increase the accuracy and qualified rate of detection. All the manufacture process will conduct in accordance with the standards of ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes.
III. Quality Control for analyzers :The patented Eu2+ & Mn2+ element quality control card employ absolute quantification method to assign values, which keeps the analyzer CV<1%.
Iv. Quality control of reagent R&D: self-developed freeze-dried powder quality controls (Levey-Jennings quality control)
Number | Controls | Number of registration certificate |
1 | 降钙素原质控品(Procalcitonin(PCT)Control) | 粤械注准 20172400844 |
2 | 白介素6质控品(Interleukin-6(IL-6)Control) | 粤械注准 20172400852 |
3 | C反应蛋白质控品(C-Reactive Rrotein(CRP)Control) | 粤械注准 20172400847 |
4 | 心肌肌钙蛋白 I 质控品(Cardiac Troponin I(cTnl)Control) | 粤械注准 20172400846 |
5 | 肌酸激酶同工酶质控品(Creatine kinase Isoenzyme-MB(CK-MB)Control) | 粤械注准 20172400849 |
6 | D · 二聚体制控品(D-Dimer Control) | 粤械注准 20172400843 |
7 | 人心型脂肪酸结合蛋白质控品(Human Heart-type Fatty Aeid Binding Rrotein(H-FABP)Control) | 粤械注准 20172400851 |
8 | 肌红蛋白质控品(Myoglobin(MYO)Control) | 粤械注准 20172400848 |
9 | N末端脑钠肱前体质控品(N-terminal pro-B-type natriuretic peptide(NT-proBNP)Control) | 粤械注准 20172400845 |
10 | 中性粒细胞明胶酶相关 脂质运载蛋白质控品(Neutrophil gelatinase-assoiated lipocalin(NGAL)Control) | 粤械注准 20172400850 |
Levey-Jennings control chart
Description:
1.31 quality control test results are plotted in the chart. The quality control chart Have warning limit set as X+2SD and control limit set as X+3SD.
2.Levey-Jennings is the most commonly used control chart in laboratory . In general, the laboratory inspects the quality of the detection results by measuring the controls, and plots the quality control results on control chart. According to the control rules, the laboratory decides whether the detection is “in-control” or “out-of-control”.
3.We have the quality control conditions and strictly implement the international general quality control standards.
V. In clinical application: reading SD card for system calibration; the Control line used to eliminate abnormal reactions.
Description:
T line : Test line C line : Control line. In clinical application, the fluorescence intensity on Test line is directly proportional to sample concentration, so as to achieve quantitative detection. When the analyzers recognize the absence of Control line, the analyzers will classify the result to be invalid and do not calculate the measurement data, so as to eliminate abnormal reactions and ensure the accuracy of clinical test results.
Our core competencies
1.We are the first company in the world to bring QDs from academic research to clinical test.
2.We are the first company in the world to develop, produce and industrialize QDs diagnostic reagents.
3.We are the first domestic company to put forward and implement the concept of Whole-Process Quality Control.
4.We are the only company with peripheral blood registration certificate from CFDA(QDs Immunofluorescence chromatography).
5.We are the only company in the world with the exclusive patents for PCT/IL-6, PCT/ IL-6 /CRP combined detection.
6.We are the only company in the world achieve hs-cTnI assay with a LOD of 0.005ng/mL.