BioCore COVID-19

Fast Real Time PCR Kit

The best partner for total molecular diagnostics technology

Get your test results in 1 hour!

- PCR run time reduce to as little as 40 minutes

Test procedure of BioCore COVID-19 Fast Real Time PCR

5000
5000
40005000
4000
30004000
3000
20003000
2000
10002000
Turn around time† From 4 hrs to as short as 1 hr
1000
0 1000
0 0 10 20 30 40
00 10 20 30 40
0 10 20 30 40

Run time‡ From 2.5 hrs to as little as 40 min

STEP 1 STEP 2 STEP 3 STEP 4

Collection Specimen Nucleic Acid Extraction PCR Amplification Reporting

Sample Collection Nucleic Acid Extraction RT-PCR Amplification Results

Sputum RNA extraction from Ct value of N gene and

Oropharyngeal (OP) samples CFX96 Dx System RdRp gene
Nasopharyngeal (NP) Preparation of COVID-19
Swabs Fast RT Reaction Mixture

1 2 3 4

Within 40 minutes!

†
Laboratory can get test results in about 4 hours from the time they get a sample
‡
Real-time PCR may take approximately 2.5 hours with general 2019-nCoV Real-time PCR Kits

Ver. 1st Jan 2021

BioCore co, ltd
HQ. 8F, 33, Digital-ro 9-gil, Geumcheon-gu, Seoul, 08511 Rep. of Korea
Lab. 25F, 13, Heungdeok 1-ro, Giheung-gu, Yongin-si, Gyeonggi-do, 16954, Rep. of Korea
Tel. 82-2-2027-6200 www.bio-core.com
BioCore COVID-19
Fast Real Time PCR Kit

Kit Features Kit Contents (100 Tests)

Detection target Coronavirus disease (COVID-19) No. Reagents Volume

Target region Amplify N gene and RdRp(Orf1ab) gene of SARS-CoV2 1 COVID-19 Fast RT Reaction Mixture 1,100 μl
Real-time reverse transcription polymerase chain 2 COVID-19 Fast RT Primer/Probe Mixture 550 μl
Type
reaction (RT-PCR)
Specimen Nasopharyngeal / Oropharyngeal / Sputum 3 COVID-19 Fast RT Positive Control 50 μl

PCR machines CFX96 Dx System (Bio-Rad) 4 COVID-19 Fast RT Negative Control 50 μl

Storage
-20°C or below
Condition
Shelf life 12 months from the date of manufacture Kit Certificates
Running time Results in 40 minutes
Volume 100 tests to 400 tests

Target region of COVID-19 : N gene & RdRp gene

Orf1a Orf1ab S E M N

28681 ~ 28833 28681 ~ 28833

RdRp N

The inclusivity of the BioCore COVID-19 Fast Real Time PCR Kit was evaluated using in silico analysis of the assay primers and probes in relation to 3,007
of SARS-CoV-2 sequences available in the NCBI.
In "Severe acute respiratory syndrome coronavirus 2 data hub" of NCBI, 3,007 of Nucleotide complete (complete DNA) was analyzed which are
registered from November 30, 2019 to April 30, 2020.

PCR Condition

Temperature Time Cycles Target Fluorephores

50 ℃ 3 min 1
N gene FAM
95 ℃ 10 sec 1
95 ℃ 1 sec RdRp gene CalRed 610
60 ℃ 8 sec 45
Internal Control Cy5
→ Fluorescence acquiring

Clinical performance

Comparator assay

POSITIVE NEGATIVE TOTAL

POSITIVE 78 0 78
BioCore COVID-19
NEGATIVE 1 79 80
Fast Real Time PCR Kit
TOTAL 79 79 158

Positive Percent Agreement: 98.73% (95% CI: 93.17%-99.78%)

Negative Percent Agreement: 100% (95% CI: 95.36%-100.00%)
Overall Rates of Agreement: 99.37% (95% CI: 96.50%-99.89%)
Kappa Statistic = 98.73% (95% CI: 98.52%-98.92%)