Post on 28-Apr-2022
Moses Affandi• Birthplace & date
Balikpapan, 27 Mei
• EducationS1 Bioteknologi, UnikaAtmajaya Jakarta2005 - 1010
• OccupationProduct ManagerMindray Medical Indonesia2018 - present
healthcare within reach
Mindray HematologyBC-5390CRP
Moses Affandi
Hematology Product Manager
0812 1689060
moses.affandi@mindray.com
The Leader of China’s Medical Device Company
Global Player in Medical Device
Vision
Better healthcare for all
Mission
Advance medical technologies to
make healthcare more accessible
10,000+ professionals from
40+ countries
International branches in 40+countries,
with 44 branches in China
Serving190+ countries and regions
We are
Globally collaborated innovation network and service network ensures sustainable growth
Global Branch & RnD Centre
10,000+ professionals from 40+ countries
International branches in 40+ countries, with 44 branches in
China
Serving 190+ countries and regions
Menara Dea 2, Jakarta Plaza BRI, Surabaya
Indonesian Branches
BC-5390CRP – Hematology + CRP
© 2015 Mindray Confidential9
BC-5390CRP – Hematology + CRP
© 2015 Mindray Confidential10
FR-CRP
0.2-320mg/LRegular CRP
10-320mg/L
HS-CRP
0.2-10mg/L
• Both CRP levels and diameter of the largestlung lesion increased with diseaseprogression.
• CRP levels were positively correlatedwith lung lesions and severe presentation(correlation coefficient = 0.873,0.734, P ˂ 0.001).
11
12Ali, 2020 DOI: 10.1002/jmv.26097
• Patients with severe diseasecourses had a far elevated levelof CRP than mild or non‐severepatients.
• When the inflammation or tissuedamage is resolved, CRPconcentration falls, making it auseful marker for monitoringdisease severity
13
CRP Membantu Penanganan Resiko Pasien
CoViD-19
Usulan Alur Skrining OTG/ODP/PDP by PDS PatKLIn
14
Lab Dasar
DARAH LENGKAP/ CBC• ANC > 2500 /µL• ALC < 1500 /µL• NLR > 3,13
KIMIA KLINIK:• CRP >10 mg/L
RADIOLOGI:• Pneumonia / GGO
Lakukan PHBSPhysical Distancing
YA
TIDAK
Pemeriksaan Molekular(TCM/rRT-PCR)
NEGATIF2X berturut POSITIF
BukanCOVID-19
TerkonfirmasiCOVID-19
Bila tersedia
Bila tidak tersedia Rapid Test Antibodi
NEGATIF
POSITIF
WAJIB ulang7-10 hari lagi
BukanCOVID-19
WAJIB KONFIRMASI
Ulang PCR Kriteria KRS ?Tergantung Klinisi
• Tetap PHBS• Physical Distancing 14 hari
Min
dra
y-P
DS P
atK
LIn
Web
inar 1
4 A
pril 2
020
Individually CRP mode
© 2015 Mindray Confidential15
➢ Particular and individually CRP test mode saves hematology reagents for users and the result can be modified automatically as well.
CRP Channel – Immuno-latex Turbidimetry
© 2012 Mindray Confidential16
Monoclonal antibodies
Latex beads
Ghost
CRP antigens
Blood coagulation factors
Serum matrix
850nm
Turbidimetry
Previous sample
850nm
Current sample
2 channel analysis
⚫ Break cells quickly⚫ Remove interference⚫ Intensify the reactions
⚫ Specified monoclonal antibody
⚫ Immuno-latex intensified reaction
⚫ Full range response
LC lyse Latex
FR-CRP
Hematology
1 tube solution
© 2015 Mindray Confidential17
CBC + DIFF + CRP
CBC + DIFF
CRPChemistryCentrifuge
FR-CRP
0.2-320mg/L
BC-5390CRP – Hematology + CRP
© 2015 Mindray Confidential18
Mindray IVD Solutions for Diagnostic and treatment monitoring of COVID-19
Smallest with high productivity 1 tube solution for CBC+DIFF and Large and flexible capacity
chemiluminescence immunoassay CRP chemistry solutions
CK-MB Troponin I CBC DIFF Liver kidney
function function
CL-900i
BC-5390 BS-
CRP 240pro
PCT CoV-2-IgM, IgG CRP NLR Cardiac CK/CK-
CRP MB+ MYO
Ferritin, Vit D
Cardiac Marker, Trop I, CKMB, BNP
SARS-CoV-2 IgM, IgG
AAA
© 2020 Mindray Confidential
• Serology test kits of COVID-19 on Mindray CLIA systems:
1. SARS-CoV-2 IgM (CLIA)
2. SARS-CoV-2 IgG (CLIA)
Running in Fully Automatic Machine
Mindray CL- Series,
With Chemilumenescence (CLIA) Technology
Mindray COVID-19 Reagents Now
Small Package : 2*50 tests/kit Time to first result : 29 minutes
Principle : Sandwich CLIA (GLOW CLIA) Sample volume : 10 μL
Sample type : Serum Shelf life : 2-8°C,6 months
SARS-CoV-2 IgM SARS-CoV-2 IgG
Sensitivity Up to 91.5 % Sensitivity Up to 97.9 %
Specificity Up to 100 % Specificity Up to 100 %
MR
© 2020 Mindray Confidential
IgM - acute phase (several days after initial infection)
Result : Reactive, with COI ≧ 1
Non Reactive, with COI < 1A
b in
b
loo
d
Infection
IgM
IgG
IgM & IgG Pattern
SARS-CoV-2 IgM (CLIA) SARS-CoV-2 IgG (CLIA)
Ab Test Result – CLIA Mindray
IgG - later than IgM, much more effective, protective
Resut : Reactive , with Unit ≧ 10 U/ml
Non Reactive, with Unit < 10 U/ml
Target Ag: Nucleocapsid and Spike RBD
Mindray Evaluation Result at Balitbangkes
Sensitivity IgM up to 91.5 %IgG up to 97.9 %
Specificity IgM up to 100 % IgG up to 100 %
Kesimpulan : Produk Tes Serologi SARS-CoV-2- IgM, IgG (CLIA) memenuhisyarat uji validasi
© 2011 Mindray Confidential23
Assay Designs of MindrayTo Support Vaccination SARS COV-2 RBD IgG
Coming Soon
© 2011 Mindray Confidential24
Mindray Neutralizing Antibody Evaluation Result at Balitbangkes
Sensitivity RBD IgG up to 93.8 %Total Ab RBD up to 95 %
Specificity RBD IgG up to 100 % Total Ab RBD up to 98.3 %
Kesimpulan : Produk Tes Serologi SARS-CoV-2- RBD IgG, Total Ab RBD (CLIA), RUO memenuhi syarat uji validasi
© 2011 Mindray Confidential25
Reagent Name Target Antigen Cut Off Function
SARS CoV-2 IgM Nucleocapsid & S RBD COI ≥ 1 : Reactive
COI < 1 : Non Reactive
Support Diagnosis, Ab Kinetic,
Indicate Disease Course.
Pre Vaccination Screening
SARS CoV-2 IgG Nucleocapsid & S RBD ≥ 10 U/ml ; Reactive
< 10 U/ml : Non Reactive
Support Diagnosis, Ab Kinetic,
Indicate Disease Course.
Pre Vaccination Screening
SARS CoV-2 Tab
Quantitative
RBD Total: IgM, IgA, IgG ≥ 10 AU/ml : Reactive Aid to diagnosis (indicate recent
or post infection),
Seroprevalence natural humoral
immunity, may indicate vaccine-
induced humoral immunity
SARS CoV-2 RBD IgG
Quantitative
RBD IgG ≥ 6 AU/ml : Reactive
(Indonesia Populasi)
Seroprevalence natural humoral
immunity, may indicate vaccine-
induced humoral immunity
Reagent Function
Research with Post Vaccination Sample still ongoing process, will update for Cut off post vaccination
Cut off post vaccination also depend vaccine kinds and population , needed research for that
© 2011 Mindray Confidential26
© 2019 Mindray Confidential26
Mindray PCT, Ferritin, Vit D, Cardiac Marker (Trop I, CKMB Massa, MYO, BNP)
使用方便International Standard
Alat CL-Series : CL-900i,
CL- 1000i (Terdaftar di E.Catalog)
Volume sample kecil:
10-50 ul
ReagenSiap Pakai
Presisi baik
Cepat :
17-30 min
Stabilitasbaik
Teknologi Canggih: GLOW CLIA
Full otomatis
Kemasan kecil : 2 X 50 tes/kit
Harga terjangkau
MR
Thank You!
Moses Affandi
moses.affandi@mindray.com
+62 812 168 9060
Arief Arbi / Sumatera dan Jawa Barat
+62 852-7404-0020
Yohanes Alberto / Banten, Jawa Tengah dan Kalimantan
+62 815-9019-003
Aldo Candra / Jawa Timur dan Sulawesi
+62 813-2661-7956
Mirta Putri / Jawa Timur, Bali dan Nusa Tenggara
+62 815-8418-0066
Husien / Project Manager
+62 812-8167-228
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