Immuno Diagnosis

Through antigen-antibody reactions, SelexOn screens for diseases by extracting markers created by cardiac disorders, thyroid conditions, cancer and infectious diseases.

GeneFinder™ COVID-19 Ag Self Test

The GeneFinder™ COVID-19 Ag Self Test is a lateral flow immunochromatographic assay intended for the qualitative detection of nucleocapsid protein antigen from SARS- CoV-2 in nasal swab samples collected from individuals who are suspected of COVID-19 within 7 days of the onset of symptoms or infected individuals without symptom.

Detail

Features

  • Certified CE COC (EC Certificate No. 1433-IVDD-082-2022)

  • Certified Korea GMP & MFDS approval (IVD No. 22-106)

  • Easy to use screening qualitative self-test using nasal swab samples

  • Fast test result within 15 minutes

  • High sensitivity performance for infectious patients within 7days from symptom onset and asymptomatic patients

  • Available to detect the VOC [Alpha,(B.1.1.7) Beta(B.1.351), Delta(B.1.617.2), Gamma(P.1), Omicron(B.1.1529)]

Information

Purpose SARS CoV-2 antigen qualitative test
Result time 15~20 Minutes (Don’t trust the result after 20minutes)
Sample volume 4 drops of sample solution (* Extracted nasal swab samples in extraction buffer solution)
Components Test cassette, Extraction buffer tube, Tube filter cap, Sterile nasal swab, User manual, Box(Tube holder)
Optional Waste bag, Sub manual
Storage temperature 2-30 °C (Avoid the direct sun light)
Shelf life 24months from manufacture date
Box Unit 1T, 2T, 5T, 7T, 10T, 25T / Box
Sensitivity 96.67% (95% CI : 88.47% – 99.59%)
Specificity 100.00% (95% CI : 96.60% – 100.00%)

OHC COVID-19 Antigen Self Test

The “OHC COVID-19 Antigen Self Test” is intended for non-prescription self-use and as applicable, for an adult lay user testing or another aged 2 years or older. The “OHC COVID-19 Antigen Self Test” is only for use under the US Food and Drug Administration’s Emergency Use Authorization. The “OHC COVID-19 Antigen Self Test” is designed for individuals with symptoms of COVID-19 within the first 7 days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19. Those who are suspected infectious COVID-19 should perform the test at least twice over three days using “OHC COVID-19 Antigen Self Test” to detect the SARS CoV-2 antigen as quickly as possible.

Detail

Features

  • Authorization of “US FDA EUA No. 220037”

  • Self-reporting of test result through “GeneFinder+” mobile App.

  • Easy to use qualitative optimized serial home-testing

  • Fast test result within 15minutes

  • The outstanding specificity against other respiratory patients with COVID-19 similar symptoms

Information

Main For Emergency Use Authorization (FDA EUA) only
Result time 15~20 Minutes (Don’t trust the result after 20minutes)
Sample volume 4 drops of sample solution (* Extracted nasal swab samples in extraction buffer solution)
Components Test cassette, Extraction buffer tube, Tube filter cap, Sterile nasal swab, User manual, Box(Tube holder)
For more information http://www.osanghc.com/en/ifu/hometest
Purpose Detection of Nucleoproteins from only SARS-CoV-2
Age of use Self-collected and test : aged 14years or older
Adult-supported and test : aged 2 to 13years
Box Unit 1T/Box, 2T/Box, 4T/Box, 5T/Box, 25T/Box
Sampling Anterior nasal swab
USA Office OSANG LLC
Tel : +1-844-760-0556
Email : covidhometest@osangllc.com

* Please refer to healthcare provide instructions for use including performance result and detail contents.

GeneFinder™ COVID-19 Ag Plus Rapid Test

The GeneFinder™ COVID-19 Ag Plus Rapid Test is a lateral flow immunochromatographic assay intended for the qualitative detection of antigen from SARS-CoV-2 in nasopharyngeal, nasal or oropharngeal swab samples directly collected from individuals who are suspected of COVID-19 within 7 days of the onset of symptoms or infected individuals without symptom. (For professional use only)
Additionally, the GeneFinder™ COVID-19 Ag Plus Rapid Test is available to use samples nasopharyngeal swab collected in transport media(UTM/VTM) from individuals suspected of COVID-19 within seven days of symptom onset by healthcare provider.

Detail

Features

  • CE Certification : Annex III of the IVDD 98/79/EC (EC declaration of conformity)

  • EU HSC Common List : RAT Device ID # 2741 (Listing on 21 Dec 2021)

  • High clinical study performance in all global regions (Asia, Europe, MENA, Africa, South Africa and North America)

  • Available to use samples from nasopharynx, anterior nares and oropharynx for test

  • Fast test result within 15 minutes

  • Lineages detected : Variants of concern : Alpha,(B.1.1.7) Beta(B.1.351), Delta(B.1.617.2), Gamma(P.1), Omicron(B.1.1529)

  • Scientific Literature : http://www.mdpi.com/2673-8112/2/3/16

  • Article : https://www.mdpi.com/2075-4418/12/5/1126

Information

Purpose SARS CoV-2 antigen qualitative test
Result time 15~20 Minutes (Don’t trust the result after 20minutes)
Sample volume 4drops of sample solution (* Extracted nasopharyngeal, nasal or oropharyngeal swab samples with extraction buffer solution)
Components Test cassette(25), Extraction buffer tube(25), Tube filter cap(25), Sterile sampling swab(25), User manual(1), Quick guide (1), Paper stand(1)
Optional Positive control swab(1), Negative control swab(1)
Storage temperature 2-30 °C (Avoid the direct sun light)
Shelf life 24months from manufacture date
Box Unit 10T/Box, 25T/Box
Sensitivity 96.03% (95% CI : 91.55% – 98.53%) (145/151)
Specificity 99.78%% (95% CI : 98.76% – 99.96%) (451/452)

* Accordance with market status, buyers can select and order the proper one swab type for “GeneFinder™ COVID-19 Ag Plus Rapid Test” product component out of as followings.
[1. Nasopharyngeal swab / 2. Oropharyngeal swab / 3. Nasal swab / 4. Dual swab for one nose and one oral cavity ]

GeneFinder™ COVID-19 IgG/IgM Rapid Test

The GeneFinder™ COVID-19 IgG/IgM Rapid Test is a lateral flow immunochromatographic assay intended for the qualitative detection of immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to SARS-CoV-2 in human serum, plasma (heparin, EDTA, sodium citrate), venous whole blood(heparin, EDTA, sodium citrate) and capillary whole blood (from finger stick directly) around 14days of COVID-19 symptom onset. So, it can help screening diagnosis that it is recovering from COVID-19 infection through this test. (For professional use only)

Detail

Features

  • CE Certification : Annex III of the IVDD 98/79/EC (EC declaration of conformity)

  • Easy to use capillary whole blood (just 20ul) from finger stick directly for test only 2steps

  • High clinical sensitivity & specificity performance about COVID-19 infection

  • Available to detect Immunoglobulin G formed Spike protein and N protein

  • Scientific Literature regarding vaccinated people : https://jkms.org/DOIx.php?id=10.3346/jkms.2021.36.e158

  • Fast result to read within 15 minutes

  • Shelf life 24months from manufacture date

Information

Purpose Detection of IgG/IgM of SARS-CoV-2 after 14days of COVID-19 symptom onset
Result time 15~20 minutes (Don’t trust the result after 20 minutes)
Shelf life 24months from manufacture date
Storage temperature 2~30 ℃ (Avoid the direct sun-light)
Sample volume Capillary whole blood, Venous whole blood : 20uL Serum, Plasma : 10uL
Box unit 25T/Box
Component Test Cassette(25), Sample diluent solution(1), User manual(1)
Optional Safety lancet, Capillary tube, Alcohol swab
Sensitivity 95 .00% (95% CI: 88.82% – 97.85%)
Specificity 98 .00% (95% CI: 94.29% – 99.32%)

ImmunoOnTM

A POCT immunosensor based on antigen-antibody reactions, ImmunoOnTM screens for disease and checks status by qualitatively and quantitatively measuring biomarkers in human blood.

Detail

Features

  • Measures over 30 kinds of biomarkers such as cardiac and thyroid disorders, cancer and infectious diseases

  • Measures by qualitative and quantitative method

  • Convenient addition of new markers by RFID (Expandability)

  • Fast processing under Quick Test mode

  • Self-developed biomarkers

Specification

Sample Type Venous Whole Blood
Sample Volume 5~250㎕ (Refer to strip manual)
Strip Storage Temperature 2℃~30℃
Measuring Range Refer to strip manual
Display Type LCD
Measuring Time Quantitative method: 10min
Qualitative method: 20min
Humidity 10~85%
Analyzer Size / Weight 168×190×95 mm / 0.8Kg
Analyzer Storage Temperature 10℃~35℃
Analyzer Operating Temperature 18℃~32℃
Memory 1000 tests
Voltage / Current DC 9V / 3A
Communication Port Thermal Printer
Barcode Scanner
Battery (8.4V / 4400mAh)
Data Cable