ACHIEVE.

ELEVATE.

Exact Diagnostics
SARS-CoV-2 Standard/Negative (RUO)

Olly Riani Agustini

PT. Diastika Biotekindo

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ACHIEVE.
ELEVATE. Role in Quality Management System

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ACHIEVE.
ELEVATE. Biorad Quality Systems Division
One Stop Solution for QC Management
• 3rd party control
• External Quality Assurance Service
( EQAS )
• URT™
Complete QC data management
• Unity™
Inter-laboratory comparison program

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ACHIEVE.
ELEVATE.

4
ACHIEVE.
ELEVATE. Why are we hearing about this after the launch?

Bio-Rad and Exact stay nimble in responding to this pandemic

➢ On February 29, 2020 the Food and Drug Administration issued a policy
allowing the Emergency Use Authorization (EUA) of testing for Coronavirus
during this public health emergency.
■ QSD decided to redirect production at Exact Diagnostics to focus on the
development of a standard material
➢ On March 3rd the FDA publicly declared that one area of weakness is that the
current guidance requires labs to validate their tests using RNA or inactive
SARS-CoV-2 which is in limited supply.
➢ On March 5th Altona Diagnostics, a manufacturer of a SARS-CoV-2
diagnostic kit reached out directly to Exact Diagnostics in a desperate attempt
to receive standard material by March 10th to meet the 15-day EUA timeline.
■ This request accelerated the product launch timeline from 3-4 weeks to
a 5 day timeline (over the weekend).
➢ Exact managed to pass all release testing requirements and packed finish
goods through the night for an official public launch on Thursday March 12th

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ACHIEVE.
ELEVATE. What are the products?
● For Research Use Only

● This standard and negative are designed for use on

molecular diagnostic tests that detect SARS-CoV-2
nucleic acid from human specimens. The products are
not designed for use with either antigen diagnostic tests
or serological diagnostic tests.

● Molecular diagnostic tests

● Serological diagnostic tests (ex. ELISA, CLIA)
● Rapid diagnostics tests

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ACHIEVE.
ELEVATE. Validate the Entire Process of a Molecular Assay

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ACHIEVE.
ELEVATE.

Bentuk : Liquichek , frozen

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ACHIEVE.
ELEVATE.

Bentuk : Liquichek , frozen

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ACHIEVE.
ELEVATE. 5 of 5 gene targets for COVID-19!!

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ACHIEVE.
ELEVATE. Introduction

The SARS CoV-2 Standard and SARS CoV-2 Negative

contain genomic DNA allowing laboratories to validate
the entire process of a molecular assay including
extraction, amplification, and detection.

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ACHIEVE.
ELEVATE. Molecular diagnostic workflow

Assay Result
Patient Sample Sample Prep Assay
setup Analysis
Extraction DNA
PCR( for LDTs)
*Application :STD,RV, HPV

Automation
Real Time PCR

Sequencing

Manual Microarray

RNA

RT PCR → QPCR
PCR

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ACHIEVE.
ELEVATE.

13
ACHIEVE.
ELEVATE. Indication for Use

• Methods Validation (LoD)

– Assay manufacturers
– Labs set up assays as new.
– Labs change assays or add another assays.
• Lot to lot validation
– Like core labs, when reagent lot is changed
• External run control
– To use it every batch to verify result.

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ACHIEVE. Teknik pengerjaan bahan SARS-CoV-2 Standard /
ELEVATE.
Negative
Misal : biasanya untuk Covid pengambilan sample dgn Swab

• Masukan swab kering ke dalam tabung mikro yang telah diisi 1 mL Lysis
Buffer
• Vortex selama 1 menit
• Spin Down
• Inkubasi pada suhu ruang selama 10 menit

▪ Ambil RNA 200 uL untuk Deteksi

Dimulai dari sinilah

pengambilan bahan
Standard nya

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 ACHIEVE.
ELEVATE.

200.000 copies
/ mL
Of each Gen Target

200 µl 10 µl

Ekstraksi Deteksi qPCR

40.000 copies 2.000 copies

300 µl
16 60.000 copies
ACHIEVE.
ELEVATE. QC dapat dikatakan Masuk / Baik , jika :

• Memberikan Grafik yang jelas pada hasil analysis

• Hasil Standard/Positif -> CT value sebelum siklus ke
30-35 ( biasanya, tergantung dari kit deteksi )
• Hasil Negatif -> Flat / NO CT

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 Value Proposition
ACHIEVE.
ELEVATE.

Elevator Pitch: This is a new coronavirus

standard with In-Vitro transcript RNA
quantified by ddPCR against a human
genomic DNA background

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ACHIEVE.
ELEVATE.

VIROTROL SARS CoV2

VIROCLEAR SARS CoV2

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ACHIEVE.
ELEVATE. Quality Controls for Serological Tests

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ACHIEVE.
ELEVATE.

Thank you!
#staysafe
#stayhealthy

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