Novel Coronavirus 2019-nCoV Detection

What is coronavirus?

•Coronaviruses are a large family of RNA viruses includingHCoV-229E, OC43, NL63, and HKU1 that usually cause mildrespiratory illnesses with the exceptions of the fatal SevereAcute Respiratory Syndrome Coronavirus (SARS-CoV) and theMiddle East Respiratory Syndrome Coronavirus (MERS) of thelast two decades.

•A recent outbreak of pneumonia in Wuhan, China declaredon December 12th, 2019, led to the isolation and identificationof a new human coronavirus, 2019-nCoV (SARS-CoV-2), as theresponsible agent of this new acute respiratory syndrome. Thisvirus can cause the disease named coronavirus disease 2019(COVID-19). WHO refers to the virus as COVID-19 virus in itscurrent documentation.

According to WHO; globally more than 15 million COVID-19 cases were confirmed, andmore than 640 thousand deaths were reported. The cases are reported from 216countries, areas or territories.

https://covid19.who.int/

COVID-19 Testing

According to CDC; two kinds of tests are available for COVID-19: viral tests and antibody tests.

•A viral test tells you if you have a current infection.•An antibody test tells you if you had a previous infection.

Who should be tested?

Most people will have mild illness and can recover at home without medical care and may not need to betested. CDC has guidance for who should be tested, but decisions about testing are made by healthdepartments or healthcare providers.

How to collect samples?

According to CDC Guidelines; specimens should be collected as soon as possible once a decision has been made topursue testing, regardless of the time of symptom onset.

For initial diagnostic testing for SARS-CoV-2, CDC recommends collecting and testing an upper respiratory specimen.The following are acceptable specimens:

•A nasopharyngeal (NP) specimen•An oropharyngeal (OP) specimen•A nasal mid-turbinate swab (using a flocked tapered swab)•An anterior nares (nasal swab) (using a flocked or spun polyester swab)• Nasopharyngeal wash/aspirate or nasal wash/aspirate (NW)

Swabs should be placed immediately into a sterile transport tube containing 2-3mL of either viral transport medium(VTM), Amies transport medium, or sterile saline, unless using a test designed to analyze a specimen directly, (i.e.,without placement in VTM).

https://www.cdc.gov/coronavirus/2019-ncov/lab/guidelines-clinical-specimens.html

COVID-19 Detection Methods

Immunoassays Molecular Assays

Serologic assays for SARS-CoV-2, now broadly available.These assays can play an important role in understandingthe virus’s epidemiology in the general population. Unlikeviral direct detection methods such as nucleic acidamplification or antigen detection tests that can detectacutely infected persons, antibody tests help determinewhether the individual being tested was ever infectedeven if that person never showed symptoms.

Serologic tests detects SARS-CoV-2 virus infectionindirectly therefore these tests cannot typically replacedirect detection methods as the primary tool fordiagnosing an active SARS-CoV-2 infection. But they arevery important for monitoring and responding to theCOVID-19 pandemic.

Currently, there is no identified advantage of theseassays whether they test for IgG, IgM and IgG, or totalantibody.

The preferred testing method is the real-time reversetranscription-PCR (RT-PCR) test. These tests detectsSARS-CoV-2 virüs directly. Within 5 to 6 days of theonset of symptoms, patients with COVID-19 havedemonstrated high viral loads in their upper and lowerrespiratory tracts. A nasopharyngeal (NP) swab and/or anoropharyngeal (OP) swab are often recommended forscreening or diagnosis of early infection.

Results are for the identification of SARS-CoV-2 RNA.The SARS-CoV-2 RNA is generally detectable in humanoropharyngeal swab and nasopharyngeal swabspecimens during the acute phase of infection. Positiveresults are indicative of active COVID-19 infection.Laboratories are required to report all positive results tothe appropriate public health authorities.

Negative results do not preclude COVID-19 infection andshould not be used as the sole basis for patientmanagement decisions. Negative results must becombined with clinical observations, patient history, andepidemiological information.

• Chu DKW, et al 2020. Molecular diagnosis of a novel coronavirus (2019-nCoV) causing an outbreak of pneumonia. Clin Chem 66:549–555. doi:10.1093/clinchem/hvaa029• Pan Y et al. 2020. Viral load of SARS-CoV-2 in clinical samples. Lancet Infect Dis 24:30113–30114. doi:10.1016/S1473-3099(20)30113-4• https://www.cdc.gov/coronavirus/2019-ncov/testing

How we can help?

•We transform our 15 years experience into productsto help the World fights against COVID-19 pandemic.

•Together with our experienced researchers, wecombine our products that can be used in diagnosis ofCOVID-19 with the iNADx brand.

Our Products

Sample Collection

• Viral Transport Kit

Viral RNA isolation

• Nucleic Acid Purification Kit

ViralDetection

• qRT-PCR Kit

Sample Collection

iNADx Viral Transport Kit is used for collection, and transport, of clinicalspecimens and long-term storage of viruses, such as Influenza, Chlamydia,Mycoplasma and Ureaplasma specimens.

The system is used for cell culture, Rapid Antigen Detection, PCR, androutine nucleic acid extraction. It is designed to maintain the optimumviability and virulence of the viral sample. It is mainly composed of astorage tube, preservation medium, and swabs.

iNADx Viral Transport Kit is made of Hanks Balanced Salt Solution (HBSS)and contains protective protein antibiotics to control the overgrowth ofbacteria and yeasts, maintain cellular integrity and encourage thepreservation of viruses, chlamydia, and buffers to control the pH.

Product Name Package Size Cat. No

iNADx Viral Transport Kit 30 tests M2001-30

iNADx Viral Transport Kit 150 tests M2001-150

iNADx Viral Transport Kit

Product Name Package Size Cat. No

iNADx Viral Nucleic Acid Transport and Direct PCR Reagent 50 tests M2002-50

iNADx Viral Nucleic Acid Transport and Direct PCR Reagent 100 tests M2002-100

iNADx Viral Nucleic Acid Transport and Extraction Reagent

iNADx Viral Nucleic Acid Transport and Extraction Reagent is intended for transport and rapid extraction of nucleicacid from the SARS-CoV-2 in human oropharyngeal swab and nasopharyngeal swab specimens for in vitro diagnosticpurposes. The extracted viral RNA is suitable for RT-PCR, qRT-PCR, qPCR, viral detection, viral load determination andviral genotyping. Any diagnostic results produced in connection with any downstream diagnostic assay using thisreagent should be interpreted according to all relevant clinical and laboratory findings.

Mix each tube by vortexing for 1 minute

Open the Viral NucleicAcid Transport andExtraction Reagenttube

Break plastic shaftat the break pointline into the tubecontaining NAExtraction Reagent

Tightly close thetube and write thesample informationon the tube orattach a label.

Place sample tube ina ziplock bag, andtransport to thelaboratory

Mix each

tube by

vortexing for1 minute

Ready for RT-PCR, qRT-PCR,

qPCR, viral detection, viral load

determination or viral

genotyping.

Use the swab for

sampling fromnose or throat

Product Name Package Size Cat. No

iNADx Viral Nucleic Acid Extraction Reagent from Dry Swap 50 tests M2003-50

iNADx Viral Nucleic Acid Extraction Reagent from Dry Swap 100 tests M2003-100

iNADx Viral Nucleic Acid Extraction Reagent from Dry Swab

iNADx Viral Nucleic Acid Extraction Reagent from Dry Swap is intended for rapid extraction of COVID-19 RNA fromdry swab specimens for in vitro diagnostic purposes. The extracted viral RNA is suitable for RT-PCR, qRT-PCR, qPCR,viral detection, viral load determination and viral genotyping. Any diagnostic results produced in connection with anydownstream diagnostic assay using this reagent should be interpreted according to all relevant clinical and laboratoryfindings.

Mix each tube by

Remove each

collected dry swab

from its transport

container

Use the swab

for sampling

from nose or

throat

Place into a

DNase/RNase-free

1.5/2 ml

microcentrifuge

tube. Cut the

swabs using a

sterile razor blade

such that the tube

could

Add 500 μl of

NA Extraction

Reagent into

each tube

containing

sample.

Mix each

tube by

vortexing for

1 minute.

Transfer 40 μl of each sample

to the PCR tube, strip or

plate.

Then put the samples in a

thermocycler, and incubate at

65°C for 10 min and 98°C for2 min.

Ready for RT-PCR, qRT-PCR,

qPCR, viral detection, viral

load determination or viral

genotyping.

Viral Detection

iNADx COVID-19 qRT-PCR Kit is a real-time RT-PCR testintended for the qualitative detection of nucleic acid from theSARS-CoV-2 in human oropharyngeal swab and nasopharyngealswab specimens from individuals with signs and symptoms ofinfection who are suspected of COVID-19.

iNADx COVID-19 qRT-PCR Kit is intended for use by qualified andtrained clinical laboratory personnel specifically instructed andtrained in the techniques of real-time PCR and in vitro diagnosticprocedures.

This kit is a two channel (FAM and HEX) kit with detection of ORF1ab and N genes (two primer/probe sets)

Targets Targetting the conservative sequences of ORF1ab and N gene

Sensitivity For COVID-19 Target ORF1ab gene: 44 copies/mlFor COVID-19 Target N gene: 79 copies/ml

Specifity No cross-reactivity with SARS, MERS, etc.

Duration Real-time reverse transcription PCR assay is completed in 90 minutes

Control COVID-19 real-time PCR assay utilizes an internal control, which controls for target isolation and amplification

CE-IVD For in-vitro diagnostic use

is approved by The Republic of Turkey Ministry of Health

Product Name Package Size Cat. No

iNADx COVID-19 qRT-PCR Kit 100 tests D2001-100

iNADx COVID-19 qRT-PCR Kit 500 tests D2001-500

iNADx COVID-19 qRT-PCR Kit

Results in 90 minutes

Targets ORF1ab and N gene

CE-IVD marked. ISO 9001 and ISO 13485

certificates.

Internal Control (IC) is detectedsimultaneously

High quality andefficiency

Product Name Package Size Cat. No

iNADx Multiplex COVID-19 qRT-PCR Kit 100 tests D2003-100

iNADx Multiplex COVID-19 qRT-PCR Kit 500 tests D2003-500

iNADx Multiplex COVID-19 qRT-PCR Kit

Results in 90 minutes

Targets N andRdRP genes

ISO 9001 and ISO 13485 certificates.

Internal Control (IC) is detectedsimultaneously

High quality andefficiency

This kit is a three channel (FAM, HEX and Texas Red) kit with detection of RdRP and N genes (two primer/probe sets)

Targets Targetting the conservative sequences of RdRP and N gene

Sensitivity For COVID-19 Target ORF1ab gene: 44 copies/ml ; For COVID-19 Target N gene: 79 copies/ml

Specifity No cross-reactivity with SARS, MERS, etc.

Duration Real-time reverse transcription PCR assay is completed in 90 minutes

Control COVID-19 real-time PCR assay utilizes an internal control, which controls for target isolation and amplification

FOR MORE INFORMATION

Please contact us through;

Website www.inadx.net

e-mail info@inadx.net

Phone +90 (216) 519 10 20