COVID-19 Diagnostics
Solsten is the manufacturer of unique and excellent in vitro diagnostics (IVD) for use in controlling COVID-19.
Antigen Assays
| Product No. | Product Name | Regulatory Status |
|---|---|---|
| SOL-COV-001 | SARS-CoV-2 Antigen ELISA Kit | CE-IVD |
| SOL-COV-004 | SARS-CoV-2 Antigen Quantitative Rapid Test | CE-IVD |
Instrument
| Product No. | Product Name | Regulatory Status |
|---|---|---|
| SOL-COV-003 | Fluorescence Immunoassay Analyzer, BOH-180 | CE-IVD |
Antibody Assays
| Product No. | Product Name | Regulatory Status |
|---|---|---|
| SOL-COV-002 | SARS-CoV-2 Neutralizing Antibody ELISA Kit | CE-IVD |
| SOL-COV-006 | SARS-CoV-2 S&N-IgM/IgG Antibody Rapid Test | CE-IVD |
| SOL-COV-005 | SARS-CoV-2 S-IgG Antibody Quantitative Rapid Test | CE-IVD |
COVID-19 Antigen Assays
Screening for COVID-19 by quantification of SARS-CoV-2 Antigen in blood samples.
SARS-CoV-2 Antigen ELISA Kit:
- Product No. SOL-COV-001 (96 wells)
- Unique high throughput assay for diagnosis of early stage COVID-19 by analysis of blood samples (plasma or serum).
- Particularly suitable for screening SARS-CoV-2 nosocomial infection, since:
- It uses already existing blood samples (i.e., blood sample residuals) collected from inpatients at hospitals (no extra sampling);
- It takes little manual labor to analyse hundreds of samples in one run;
- It is at least 4x cheaper per inpatient than screening based on PCR-analysis of pharyngeal samples.
- Clinically documented, CE-IVD marked ELISA kit including all necessary reagents.
SARS-CoV-2 Antigen Quantitative Rapid Test:
- Product No. SOL-COV-004 (25 tests).
- Easy-to-use Quantitative Rapid Test for SARS-CoV-2 Antigen in blood samples.
- Apply one drop of blood (fingerprick full blood or serum/plasma from venous blood sample).
- Results in 15 minutes and quantitative reading by BOH-180 Analyzer instrument in 20 seconds.
- Clinically documented, CE-IVD marked quantitative rapid test.
COVID-19 Instrument
- Product No. SOL-COV-003.
- Simple to use, plug-and-play instrument with touch screen.
- Quantifies signals in cassettes from Rapid Tests SOL-COV-004 and SOL-COV-005.
- Quantifies Antigen (pg/ml) and Antibody (AU/ml) by fluorescence signal.
- Reports result to screen or electronically to either USB-stick or laboratory information system (LIS).
- Clinically documented, CE-IVD marked instrument.
COVID-19 Antibody Assays
Estimation of COVID-19 protection after vaccination by analysis for SARS-CoV-2 Antibodies in blood samples.
The Solsten SARS-CoV-2 Neutralizing Antibody ELISA Kit:
- Product No. SOL-COV-002 (96 wells).
- Quantitative, high throughput analysis for neutralizing antibodies in blood samples.
- The ELISA specifically quantifies the neutralizing activity (titer) of those antibodies, which will:
- Block the receptor-binding domain (RBD) of the S1 subunit of virus’ Spike protein.
- Thereby preventing the S1-RBD attachment to the human host cell ACE2 receptor.
- This is achieved in a single step competitive ELISA based on:
- ELISA-wells precoated with S1-RBD
- Simultaneous competitive incubation of blood sample (antibodies) and peroxide-labeled ACE-2
- Particularly suitable for determining the neutralizing antibody titer after COVID-19 vaccination.
- It takes little manual labor to analyse hundreds of samples in one run.
- Clinically documented, CE-IVD marked ELISA kit including all necessary reagents.
SARS-CoV-2 Antibody Rapid Test (Colloidal Gold Method):
- Product No. SOL-COV-006 (25 tests).
- Easy-to-use Rapid Test for IgG and IgM antibodies reacting with antigens (N and S) of SARS-CoV-2.
- Apply one drop of blood (fingerprick full blood or serum/plasma from venous blood sample).
- Results in 10 minutes and qualitative reading by eye (pregnancy-test like output).
- Clinically documented, CE-IVD marked rapid test for immediate use.
SARS-CoV-2 Antibody Quantitative Rapid Test (Fluorescence Method) and Reader Instrument:
- Product No. SOL-COV-005 (25 tests).
- Easy-to-use Quantitative Rapid Test for antibodies reacting with the receptor-binding domain (RBD) of the spike (S) protein of SARS-CoV-2.
- Apply one drop of blood (fingerprick full blood or serum/plasma from venous blood sample).
- Results in 15 minutes and quantitative reading by BOH-180 Analyzer instrument in 20 seconds.
- Clinically documented, RUO test.