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Curriculum Vitae

Name : Hansen GuoEmail : hansen@siemens-healthineers.com

Education Background : 1. Profesi Apoteker – Fakultas Farmasi Universitas Indonesia (2013-2014)2. S1 – Fakultas Farmasi Universitas Indonesia (2009-2013)

Working Experience :1. Clinical & Assay Marketing – Siemens Healthineers (2019-Now)2. Business Development Spc. & Asst Manager – Dipa Healthcare (2014-

2019)

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Peranan Siemens Healthineers dalam Penanganan Pandemik Covid-19Hansen, S.Farm, AptJakarta, 28 Juni 2020

Author | Department

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Kasus Infeksi Baru SARS-CoV-2 Masih Terus Meningkat

Source: https://infographics.channelnewsasia.com/covid-19/map.html (Updated 24 June 2020)https://www.worldometers.info/coronavirus/

9,173,05

8 cases474,033

deathAsia Pacific Regions

Cases (As of 24 June 2020)

India 440,215 China 83,418

Indonesia 47,896 Singapore 42,432 Phillipines 31,825

Japan 17,980 Korea 12,484

Malaysia 8,590 Australia 7,492 Thailand 3,156

New Zealand 1,165 Taiwan 446

Vietnam 349

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Perlu Adanya Pemeriksaan yang Dapat Menilai Status dan Kondisi Pasien / Orang yang dicurigai Terinfeksi Sars COV 2

World Health Organization. Coronavirus disease 2019 (COVID-19) Situation Report – 44. https://www.who.int/emergencies/diseases/novel-coronavirus2019/situation-reports/, https://www.ifcc.org/ifcc-news/2020-03-26-ifcc-information-guide-on-covid-19/, Report of the WHO-China Joint Mission on Coronavirus Disease 2019 (COVID-19), March 22, 2020 ,Content source: National Cent Immunization and Respiratory Diseases (NCIRD) Division of Viral Diseases JAMA.2020 Feb7. doi:10,1001/jama,20201585, Ann Transl Med 2020;8(3):48, http://dx.doi.org/10.21037/atm.2020.02.06, Lippi G, Plebani M. Laboratory abnormalities in patients with COVID-2019 infection. Clin Chem Lab Med. 2020 Mar 3. doi: 10.1515/cclm-2020-0198., Report of the WHO-China Joint Mission on Coronavirus Disease 2019 (COVID-19) https://www.massgeneral.org/news/coronavirus/coronavirus-latest-updates, Jingyuan Liu, https://doi.org/10.1101/2020.02.10.20021584 doi: Hematologic parameters in patients with COVID-19 infection 10.1002/ajh.25774

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1. Diagnosis (Molecular Testing) FTD SARS-CoV-2 Assay (CE-IVD)

Kit description§ 32 reactions/kit up to 30 sample klinis

§ Termasuk dalam kit :§ Primer/probe mix (SARS-CoV-2 and IC)§ Enzyme & buffer§ Positive & negative controls§ Internal control (IC)

§ Target Gen : N & ORF1ab

§ Validated extraction method: NucliSENS easyMAG (bioMerieux)

§ Validated Thermocycler: Applied Biosystems 7500 Real-Time PCR System Label will be in CE-IVD

Primer/probe regions

(http://www.fast-trackdiagnostics.com/human-line/products/ftd-sars-cov-2/)

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INTENDED USE (OUS)

Parameter SARS‑ CoV‑ 2 Total (COV2T) dapat mendeteksi secara kualitatif total antibodi Sars-Cov-2 (IgG dan IgM) pada serum dan plasma (EDTA and lithium heparin) manusia dengan menggunakan alat Atellica® IM Analyzer & ADVIA Centaur® XP/XPT.

Pemeriksaan ini didesain untuk membantu mendiagnosis pasien yang dicurigai terinfeksi Sars Cov 2 dan membantu menentukan respon imun pasien (IgG dan IgM) yang mungkin pernah terinfeksi oleh virus Sars Cov 2.

1. Diagnosis (Serology Testing) Atellica IM/ADVIA Centaur COV2T Antibody Assay

Pemeriksaan SARS-CoV-2 Total (COV2T) Assay digunakan secara efektif untuk pemeriksaan luas dengan tingkat akurasi, kecepatan, dan ketersediaan yang besar.

For use under Emergency Use Authorization only.

This test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has been authorized only for detecting the presence of antibodies against SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Product availability may vary by country and is subject to regulatory requirements.

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Reagent Siemens Healthineers SARS-CoV-2T Sudah Mendapatkan EUA dari FDA

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Tidak Semua Pemeriksaan Serologi (Antibodi) Diciptakan Setara

This test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has been authorized only for detecting the presence of antibodies against SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Product availability may vary by country and is subject to regulatory requirements.

3 Keunggulan Utama Siemens Healthineers COV2T Assay: Identifikasi respon imun yang mudah dengan memeriksa

Total Antibodi dibandingkan hanya memeriksa IgG maupun IgM.

Pemilihan antigen S1RBD untuk mendeteksi antibodi yang menghalangi masuknya virus kedalam sel.

Hasil pemeriksaan Antibodi Sars-CoV-2 yang terpercaya dan cepat sehingga dapat digunakan pada pemeriksaan skala besar baik laboratorium rujukan ataupun laboratorium2 darurat selama pandemic Covid-19

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Seroconversion: Timeline for Theoretic IgM and IgG Production

Timeline of Levels of IgM and IgG Antibody to SARS-CoV-2 from Onset of Symptoms

Deteksi Respon Imun yang Mudah dengan Memeriksa Total Antibodi

https://www.journalofinfection.com/article/S0163-4453(20)30138-9/pdfProfile of Specific Antibodies to SARS-CoV-2: The 1st Report; Xiao et alLong, Q., Liu, B., Deng, H. et al. Nat Med (2020). https://doi.org/10.1038/s41591-020-0897-1

Seru

m A

ntib

ody

Conc

entr

atio

n

0 5 10 252015

Days After Exposure

IgM

IgG

Days after symptom onset

10090

807060

50

4030

20

10

0

2–4 5–7 8–10 11–13 14–16 17–19 20–22 23+

Posi

tive

rate

(%)

IgGIgMIgG and/or IgM

Antibody

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Pemilihan Antigen S1RBD untuk Mendeteksi Antibodi yang Menghalangi Masuknya Virus ke dalam Sel

Guo et al. Military Medical Research (2020) 7:11 https://www.prosci-inc.com/ace2-antibodies/

ssRNA

E Protein

Spike

Matrix

N ProteinHuman

CellACE2

ACE2

SARS CoV-2

ACE2

ACE2

Evidence shows that antibodies to the spike protein are neutralizing – an important link to vaccine development

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Hasil Pemeriksaan yang Terpercaya dan Cepat

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2. Monitoring Terapi Pemeriksaan Kimia maupun Imun yang tersedia pada Alat Siemens

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Sistem Pengujian Gas Darah Digunakan untuk Memonitoring Kondisi Pasien Dengan Gangguan Pernapasan

RAPIDLab® 348EX Sistem Analisis Darah Epoc®

Mengukur gas dan kimia darah < dari 1 menit • Mengukur pH, pCO2, pO2, Na+, K+, Ca++, or Cl- and hematocrit

• Hasil yang cepat: 60 detik• Sampel < 50 uL

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Alat Diagnostic Siemens Healthineers pada E-Katalog

Author | Department

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Thank you!

HansenClinical & Assay Marketinghansen@siemens-healthineers.com

This test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has been authorized only for detecting the presence of antibodies against SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Product availability may vary by country and is subject to regulatory requirements.