MACCURA LABORATORIES

2019-nCoV (ORF1ab / E / N Gene) Nucleic

Acid Detection Kit
SARS-CoV-2 Fluorescent PCR Kit

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3 Methods of COVID-2019 IVD Test Solution
from Maccura

Fluorescence PCR CLIA Colloaidal Gold Method

Detection
Nucleic acid Antibody Antibody
Substance

Type of Oropharyngeal swabs,

Serum/Plasma Serum/Plasma/Whole blood
sample sputum

Time to get
2 hours 20 minutes Fastest 150 seconds
result

Insturment
Yes Yes,i 3000, i 1000 No
needed or not

Laboratory
High Relatively high Average
requirement

Confirming diagnosis(The
clinical diagnosis and
treatment of patients
should be considered in Nucleic acid negative NUcleic acid negative sample
Product Usage combination with other sample reviewing or High- reviewing or Basic hospital
symptoms/signs, medical Volume smaple detection sample testing.
history, other laboratory
tests and treatment
responses.)

● Triple detection to prevent missing detection：

Simultaneous detection of the three genes of ORF1ab / E / N in 2019-nCoV, meeting the requirements of
relevant documents of the World Health Organization (WHO)

● Add internal control and monitor the whole process：

For each test, an internal control is added to the test reagent to prevent false negative test results.

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 ● Armored RNA to ensure quality：
The positive control and internal control of the kit are armored RNA particles, which are closer to the
detection of the virus structure, contain coat protein, and participate in the extraction with the sample
at the same time, better monitor the entire experimental process and ensure the reliability of the test
results

● Optimized processes, efficient and safe：

Reagent and instrument matching verification to optimize the testing process. It takes only two hours
from safe sample processing to stable testing data output, which improves the testing speed and
protects the safety of front-line workers.

Two steps of detection :

1st step is to extract virus RNA from the sample.
2nd step is to perform RT-PCR amplification.
Products produced by Maccura are as follows:

Process Type Product Specification Validity Sample Type

Nucleic Acid
Automated GN7101907
Extraction Kit 12 Months
Extraction (32 Tests)
(Automated)

Nucleic Acid
1st Step Manual GN7102903
Extraction Kit 12 Months
Extraction Extraction (48 Tests) Oropharyngeal swabs
(Manual)
and sputum
Nucleic Acid specimens
Fast GN7101909
Extraction Kit 12 Months
Extraction (32 Tests)
(Fast)

SARS-CoV-2 6
2nd Step EGN7101109
RT-PCR Fluorescent PCR Months(Note
Amplification (32 Tests)
Kit 1)

Process Insturment Kit NOTE

Nucleic Acid
Option 1: with Allsheng
Extraction Kit
Auto-Pure 32A
(Automated)
1st Step: Extraction
Nucleic Acid Magnetic bead-based
Option 2: Manual
Extraction Kit extraction training is
extraction
(Manual) required.

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 Option 3: Manual Nucleic Acid
extraction (Fast) Extraction Kit (Fast)

Option 4: Manual
QIAamp viral mini Kit
extraction

ABI 7500, HONGSHI

SLAN-96P, or other real-
time PCR instrumente.g.
2nd Step: ABI Q5, Roche LightCycler SARS-CoV-2
Amplification 480II (Theoretically, 4- Fluorescent PCR Kit
fluorescence channels
and above are
compatible)