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Exdia COVID-19 Antibody test & Exdia TRF analyzer

Negotiable / | Min Order Quantity Unit

Required Quantity

Place of Origin
South Korea
Payment Terms
Negotiable
Production method
Negotiable
Shipping / Lead Time
Negotiable / Negotiable
Keyword
antibody , rapid , covid , iggigm
Category
Examination & Testing Instrument , Monitoring & Diagnostic Equipment

1 Precision Bio Co., Ltd.

Supplier Activity

tradeKorea provides seller activity to buyers through seller evaluation and measurement according to each item.

Country South Korea South Korea

DUNS

PRODUCT DESCRIPTION
COMPANY INFORMATION
Product name Exdia COVID-19 Antibody test & Exdia TRF analyzer Certification CE
category Examination & Testing Instrument
Monitoring & Diagnostic Equipment
Ingredients -
Keyword antibody , rapid , covid , iggigm Unit Size -
Brand name - Unit Weigh -
origin South Korea Stock -
Supply type - HS code -
Product Information

 

 

ExdiaCOVID-19 IgG/IgM is a high sensitivity Time-Resolved Fluorescence immunoassay for the qualitative detection of human IgG/IgM

antibodies to SARS-CoV-2 in human whole blood, plasma (Heparin/EDTA) and serum sample collected by healthcare workers at the point of

care. TheExdiaCOVID-19 IgG/IgM is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2,

indicating recent or prior infection. Test results ofExdiaCOVID-19 IgG/IgM should not be used as the sole basis to diagnosis.

 

 

Features

 

• High sensitivity & accuracy

• Fast results in 15 minutes

• For use with Exdia TRF analyzers

   - Objective and reliable test results

   - Built-in printer

   - Network connectivity (LIS)

 

 

Application

 

Serology testing for COVID-19 can be used to identify whether people were previously infected by SARS-CoV-2 even if they haven’t shown

symptoms. This is important to determine, because the RT-PCR tests now being used to diagnose the coronavirus can detect the presence of

the viral material during infection, but it doesn’t indicate if the person was previously infected and subsequently recovered.

 

• Identify asymptomatic patients

• Help to verify quarantine release

• Rapid screening of suspected case

• Epidemiological tracing

 

 

Test procedure

 

1. Collect 10mL of whole blood using disposable capillary tube (provided) or 5mL of plasma or serum using liquid handling pipette (not provided).

2. Allow the disposable capillary tube or liquid handling pipette to touch lightly on the pad underneath the sample well.

3. Add two drops of developer buffer into the developer well right after injecting the specimen.

4. Read the results at 15 minutes. The test cassette should be analyzed by theExdiaanalyzer according to the instruction manual.

 

 

Clinical performance

 

Exdia COVID-19 IgG/IgM

Comparator RT-PCR

Total

Positive

Negative

Positive

IgG+/IgM+

40

0

40

IgG+/IgM-

14

0

14

IgG-/IgM+

0

5

5

Negative

IgG-/IgM-

3

145

148

Total

57

150

207

Positive Percent Agreement (PPA) =54/57(94.74%), 95% CI: 85.63 to 98.19%

Negative Percent Agreement (NPA) =145/150(96.67%), 95% CI: 92.43 to 98.57%

The Overall Percent Agreement (OPA) = 199/207(96.14 %)95% Cl: 92.56-98.03%

 

 

Order information

 

Catalog No.

Product Name

Sample types

Package

Storage condition

Shelf life

PR-FC12

ExdiaCOVID-19 IgG/IgM

Whole blood, Plasma, Serum

20 tests

2~30

12 months

 

 

 

 

 

 

B2B Trade
Price (FOB) Negotiable transportation -
MOQ Negotiable Leadtime Negotiable
Payment Options Negotiable Shipping time Negotiable
Company

Precision Bio Co., Ltd.

Country South Korea South Korea

Supplier Activity

President
KIM HAN SIN
Address
306 Techno 2 ro, Yuseong-gu, Daejeon, Korea
Product Category
Examination & Testing Instrument,Monitoring & Diagnostic Equipment,Medical Test Kit,Other Examination & Testing Instrumnet,Other Monitoring & Diagnostic Equipment
Year Established
2015
Company introduction

 

Verified Certificate

  • CE

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