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.
Features
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Certified CE COC (EC Certificate No. 1433-IVDD-082-2022)
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Certified Korea GMP & MFDS approval (IVD No. 22-106)
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Easy to use screening qualitative self-test using nasal swab samples
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Fast test result within 15 minutes
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High sensitivity performance for infectious patients within 7days from symptom onset and asymptomatic patients
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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.
Features
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Authorization of “US FDA EUA No. 220037”
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Self-reporting of test result through “GeneFinder+” mobile App.
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Easy to use qualitative optimized serial home-testing
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Fast test result within 15minutes
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The outstanding specificity against other respiratory patients with COVID-19 similar symptoms
Information
| Main | For Emergency Use Authorization (FDA EUA) only |
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| 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 |
| Mobile Application | Privacy Policy Terms Of Use |
| 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.
Features
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CE Certification : Annex III of the IVDD 98/79/EC (EC declaration of conformity)
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EU HSC Common List : RAT Device ID # 2741 (Listing on 21 Dec 2021)
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High clinical study performance in all global regions (Asia, Europe, MENA, Africa, South Africa and North America)
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Available to use samples from nasopharynx, anterior nares and oropharynx for test
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Fast test result within 15 minutes
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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)
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Scientific Literature : http://www.mdpi.com/2673-8112/2/3/16
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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)
Features
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CE Certification : Annex III of the IVDD 98/79/EC (EC declaration of conformity)
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Easy to use capillary whole blood (just 20ul) from finger stick directly for test only 2steps
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High clinical sensitivity & specificity performance about COVID-19 infection
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Available to detect Immunoglobulin G formed Spike protein and N protein
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Scientific Literature regarding vaccinated people : https://jkms.org/DOIx.php?id=10.3346/jkms.2021.36.e158
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Fast result to read within 15 minutes
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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.
Features
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Measures over 30 kinds of biomarkers such as cardiac and thyroid disorders, cancer and infectious diseases
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Measures by qualitative and quantitative method
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Convenient addition of new markers by RFID (Expandability)
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Fast processing under Quick Test mode
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Self-developed biomarkers
Specification
| Sample Type | Venous Whole Blood |
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| 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 |