International Standards Both the cassettes and the AFS-1000 reader are both CE marked as in vitro diagnostic medical devices under the IVDD 98/79/EC. Regulatory approvals for Italy, Germany, Turkey, Colombia, Honduras, Dominican Republic. FDA EUA and authorisation by Health Canada under the Medical Devices Regulations are pending. Cassette Storage and Stability Keep in a cool, dry place. When stored between 2-30 ℃ the cassette remains valid for 18 months. Do not freeze. Emission Frequency The excitation frequency of the device is 475nm and the fluorescence emission from the region of interest of the LFIA test strip is 525nm. Dimensions and Weight The AFS-1000 are 300mm x 215mm x 150mm. Weight is 2.5 kg. Suitable for use in both point of care / need and laboratory settings. Connectivity Built-in printer supports automatic printing of test reports. Built-in 4G, USB2.0, RS232C, Wi-Fi, Ethernet, LIS, HIS. 7 inches 24 bits colour touch screen. 4D scanner.

FAQs | MFX Biotech

Q: Are the Tests Accredited?

Yes . All our tests are CE marked for professional use and are therefore suitable and ready for use by healthcare professionals. In addition to clinical evaluations already completed on the product, we are currently working with a number of independent laboratories and Departments of Health across Europe to further validate the product and gain best practice approvals.

Q: Will the Antibody Test Show I'm Immune?

No . No antibody test can 'prove' immunity. Scientists are still unsure of the levels of immunity that result from getting the illness or getting a vaccine, the duration of any immunity and how robust it will be against future variants.

Are the Tests Accredited?

Are the Tests Accredited?

Yes. All our tests are CE marked for professional use and are therefore suitable and ready for use by healthcare [...]

MFX Biotech2021-05-23T16:01:46+01:00May 23rd, 2021|COVID Test, Antibody Test|

Will the Antibody Test Show I’m Immune?

Will the Antibody Test Show I’m Immune?

No. No antibody test can 'prove' immunity. Scientists are still unsure of the levels of immunity that result from getting the [...]

MFX Biotech2021-05-23T15:57:50+01:00May 23rd, 2021|Antibody Test|

What is a Buffer Solution

What is a Buffer Solution

A buffer solution acts as the carrier for the sample, allowing it to flow along the test strip. It also [...]

MFX Biotech2021-05-23T15:54:36+01:00May 23rd, 2021|Explainer, Antibody Test, COVID Test|

How Antibody Tests Work

How Antibody Tests Work

Embedded into the test strip are antibodies that bind to a COVID-19 specific biomarker, the immunoglobulin specific to the viral [...]

MFX Biotech2021-05-23T15:50:21+01:00May 23rd, 2021|Antibody Test|

How Do False Positives and False Negatives Arise?

How Do False Positives and False Negatives Arise?

Have you heard of Bayes Theorem? Which means most positive results for ANY test might be false?

MFX Biotech2021-02-28T16:37:07+00:00February 26th, 2021|Explainer, COVID Test, Science|

AFS-1000: Technical

AFS-1000: Technical

International Standards Both the cassettes and the AFS-1000 reader are both CE marked as in vitro diagnostic medical devices under [...]

MFX Biotech2021-02-21T15:58:40+00:00February 21st, 2021|COVID Test|

Immunofluorescence Test Limitations

Immunofluorescence Test Limitations

The SARS-CoV-2 Antigen Rapid Test Cassette is an acute-phase screening test for qualitative detection. Sample collected may contain antigen titles [...]

MFX Biotech2021-02-21T15:48:26+00:00February 21st, 2021|COVID Test|