Curriculum Vitae - PATELKI · 2020. 6. 28. · Profesi Apoteker – Fakultas Farmasi Universitas...
Transcript of Curriculum Vitae - PATELKI · 2020. 6. 28. · Profesi Apoteker – Fakultas Farmasi Universitas...
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Curriculum Vitae
Name : Hansen GuoEmail : [email protected]
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 [email protected]
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.