The first SARS-CoV-2 self test to receive WHO Emergency Use Listing


Our OnSite® COVID-19 Ag Self Test is the FIRST to receive the WHO Emergency Use Listing for a SARS-CoV-2 self test.

We’re proud to be the the first self test granted WHO Emergency Use Listing for meeting the WHO’s high quality, safety, and performance requirements. 

The WHO Emergency Use Listing procedure assesses the suitability of health products during public health emergencies to make medicines, vaccines and diagnostics available as rapidly as possible to address the emergency while adhering to stringent criteria of safety, efficacy/performance and quality.

Learn more about how the emergency use listing works:
WHO issues its first emergency use listing for a SARS-CoV-2 self-test | WHO – Prequalification of Medical Products (IVDs, Medicines, Vaccines and Immunization Devices, Vector Control)

You only find what you look for

How a certain species of the unwelcomed Legionella might be more common than the numbers suggest.

The potentially fatal Legionnaires’ disease is caused by the bacterium Legionella. Several different species of Legionella exist. However, one species is responsible for most infections around the world – namely Legionella pneumophila.

Or so we think. 

Because, what if other Legionella species aren’t found, simply because we don’t test for them? 

This question is raised by a Swedish study conducted following a 2018 outbreak of Legionnaires’ disease. Here, authorities discovered that the cause of infection was another species than the usual suspect, Legionella pneumophila. In 30 out of 41 reported cases, the perpetrator was identified as Legionella longbeachae.

The cases couldn’t be tied to people traveling from certain countries, bringing home this supposedly uncommon species. Instead, the study found evidence that the infections were caused by handling gardening soil.

What’s more, the study found that the cases weren’t related to one specific type or brand of soil. This wasn’t just a bad apple from a single soil supplier: The researchers were able to isolate Legionella longbeachae in different soils.

So, why this sudden outbreak of Legionnaires’ disease caused by the soil-transmitted Legionella longbeachae? In Europe, only 1% of reported cases can be attributed to this specific species, so the Swedish numbers from 2018 were well off the charts. The answer may be found 14.000 kilometers around the world.

The researchers point to the simple fact that it takes specific types of tests to find specific types of Legionella. And Swedish healthcare – as in most of the rest of the world – only tests for the well-known Legionella pneumophila.

In Australia and New Zealand, however, health care institutions routinely test for Legionella longbeachae because this species is far more common there than in the rest of the world.

But what if – the study asks – it’s the other way round? What if Australia and New Zealand detect Legionella longbeachae far more often simply because they test for this species far more often?

Numbers from New Zealand do seem to favour this explanation: When the country introduced PCR testing for Legionella Longbeachae, authorities observed a fourfold increase in annual Legionnaires’ disease cases, with the majority caused by Legionella longbeachae.

You only find what you look for – or as the researchers dryly put it: “As additional diagnostic methods are needed to confirm other species of Legionella, these species are likely to be under-reported…”

References

Löf Emma, Chereau Fanny, Jureen Pontus, Andersson Sabina, Rizzardi Kristina, Edquist Petra, Kühlmann-Berenzon Sharon, Galanis Ilias, Schönning Caroline, Kais Madeleine, Tideholm Nylén Anne, Wallensten Anders, Roth Adam, on behalf of the National Outbreak Investigation Team. An outbreak investigation of Legionella non-pneumophila Legionnaires’ disease in Sweden April to August 2018: Gardening and use of commercial bagged soil associated with infections. Euro Surveill. 2021;26(7):pii=1900702. https://doi.org/10.2807/1560-7917.ES.2021.26.7.1900702

Test for two strains of Legionella in one go

With ImmuView® Legionella pneumophila and Legionella longbeachae you can detect Legionella in patients suspected of being infected with Legionnaire’s disease from either Legionella pneumophila or Legionella longbeachae. ImmuView® is the first and still the only quick test for Legionella longbeachae. It gives you clear insight and lets you initiate the right treatment from the beginning for the best possible outcome.

Read more

QuantiFERON® SARS-CoV-2 is now CE-marked

Get valuable insights into our immune system’s response to COVID-19

The QuantiFERON® SARS-CoV-2 assay measures T-cell responses to SARS-CoV-2 and aids in the assessment of immunity in individuals who have received COVID-19 vaccination.

COVID-19 vaccines stimulate the body to produce antibodies and activate T-cells to fight a SARS-CoV-2 infection. Serology tests, which measure the antibodies, often generate positive test results after vaccination but are unable to assess cellular responses. The QuantiFERON® SARS-CoV-2 assay detects CD4+ and CD8+ T-cell responses, thereby enabling a much more comprehensive assessment of immunity generated by COVID-19 vaccines.

The assay is based on QIAGEN’s QuantiFERON® interferon gamma release technology – an easy-to-use T-cell assay.

Learn more

New Lot Numbers

Update to Lot numbers for all products not part of the culture media portfolio

SSI Diagnostica A/S is preparing for IVDR implementation, as the deadline is fast approaching, we are now ready to implement a new software solution for creation of labels.

As part of this update, we will start changing the labels for our products, the two most noticeable changes will be removal of the SSID Diagnostica shield in the top right corner from the label, and a new lot number implementation.

For ImmuView an additional change will be noticeable, each component in the kit will have separate item and lot numbers.

This change does not have any effect on the product, and the quality is unchanged for the products.

The update will be implemented on a running basis in production for new productions, starting from week 43 and forward.

The new lot numbers will be a combination of three letters and up to three numbers, for some product, it will also include a dash and three additional letters plus a number.


Example on new lot number:

ABC123

DEF889

ABC1

DEF1

ABC123-XX81

DEF987-B223

New website: Simpler for the better

Today, we proudly launch the new SSI Diagnostica corporate website. Here, we want to give our costumers and partners an improved user experience, updated visual design and improved communication.

Keeping things simple is no simple task when you operate in a global and regulated market with complex products and a diverse target group.

If you work within the field of diagnostics, we are sure you will agree. Still, when we set out to build our new corporate website, simplicity is what we aimed for.

Because our field is complex enough, we wanted to make it simpler for you to find the information you need, whether you’re looking for specific product data, contact details, or industry insights.

At SSI Diagnostica, we strive to understand your business and offer relevant insights and solutions to help you simplify your operation. And rather than imposing rigid processes, we seek to operate according to your needs.

This ambition is what we wanted to convey and support throughout the new website — and which we have summed up in a new corporate core story under the headline; “Making your work simpler for the better of diagnostics.”

We hope you will find the visual design, texts, and not least user experience better and simpler.

Are you doing AST in your laboratory?

Have you seen our dRAST?

Direct and Rapid AST

If not, take a look at this fast and easy instrument for AST. Free up time and space in your lab, load directly from the positive blood culture, and in less than 7 hours you know which antibiotic and in which concentration it is needed.

SSI Diagnostica acquires American Covid-19 front-runner

In august 2020, SSI Diagnostica acquires CTK Biotech, which, among other things, develops and distributes diagnostic rapid tests. CTK Biotech is headquartered in San Diego and has production in Beijing and covers markets in Latin America, Asia and Africa, which means that SSI Diagnostica can now, together with CTK Biotech, reach patients and customers in most of the world.

“CTK Biotech are very skilled in developing new products, and their production equipment is simply excellent, with high efficiency and quality. Furthermore, our common, global distribution network will be very strong”, says CEO, Søren Skjold Mogensen, as some of the reasons for the acquisition.

With the acquisition of CTK Biotech, a new diagnostics powerhouse is created with international weight and with a focus on rapid diagnostic tests within infectious diseases. The new, combined company will have strong competencies in production, research & development, and international distribution.