Moses Affandi - PATELKI

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

[email protected]

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



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

https://www.sciencedirect.com/topics/medicine-and-dentistry/disease-exacerbation

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


➢ 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


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


CBC + DIFF + CRP

CBC + DIFF

CRPChemistryCentrifuge

FR-CRP

0.2-320mg/L

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


Assay Designs of MindrayTo Support Vaccination SARS COV-2 RBD IgG

Coming Soon


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


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



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

[email protected]

+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

mailto:[email protected]

Link: https://bit.ly/QUIZMINDRAYPATELKIHEMA5

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Moses Affandi - PATELKI

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