Rapid molecular tests for Covid, FluAB, RSV and Strep A

Hi Alexandr. We have the Cepheid at our Urgent Care departments.  The providers definitely appreciate the single swab for all 4 tests (CoV-2/Flu/RSV) and that it is a molecular test opposed to antigen.  It is a plus that the sample can either be nasal or nasopharyngeal swab. This sentiment is also shared by the operators, and I am certain to the patients as well.  The tests take about 36 minutes to run, so it is on the long side for urgent care patients to wait, but it is a lot faster than sending it out to a high complexity lab and waiting hours to days.  The kits can be kept at room temperature so that is a plus when concerned about refrigerator space.  There is some maintenance with the instrument, but it is not terribly difficult, and the vendor trained all operators thoroughly.  We have seen some issues with lot variability resulting in some errors, mainly insufficient volume along with no result due to SPC failure.  We’ve also seen some valve and reagent volume issues with the cartridges themselves.  The errors rate can vary.  All errors are particularly cumbersome as the test must be repeated with a new sample which means it will take an additional 36 minutes.  The vendor has very good customer service and pulls error logs from all the instruments we have had with errors.  They reimburse all lost material due to errors.  They are also supportive when troubleshooting.  We have had a couple of our cepheids that needed replacement for the hub, but we requested a bay replacement only which requires a Cepheid engineer to come on site.  They have been very accommodating.  Our Urgent Care departments keep an open chat line to add any issues lot wise or about troubleshooting to seek advice or just to inform others of potential issues.  Overall, we are pretty happy with the Cepheid instrument.  

 

We do have the Liat at only one location.  We use the Cov2/Flu combo kit.  They don’t make a 4plex combo like the Cepheid. The sample type is also a nasal or nasopharyngeal swab.  Run time for this test is only 20 minutes, but again, only does 3 tests instead of 4. The reagents have to be refrigerated, so you have to make sure you have enough space in the refrigerator and not order too many kits at once.  There is no major maintenance, except to clean the instrument and screen as needed. The operators that run the Liat really like it.  I rarely get complains about the instrument with lot issues or errors.  It works for this department.  

thank you Irma for your detailed and thoughtful reply! We do have Cepheid in micro department and they like it as well, but they used to charge the cartridges in a biohood, which i think is a good idea for hospital settings but not for clinics or urgent cares. Also, I just received an email from Cobas Liat that they got FDA approval for their 4plex. It will be Covid, FluAB and RSV from nasal or NP swab, 20 minutes run. It looks like the kits will be available to ship out next year. This market is changing very quick, and the big companies are competing for the customers. 

Wow!  That is excellent news.  We are already considering an alternative to the Sophia platform.  The Liat is much smaller than the Cepheid and for the rest of our departments it makes more sense to go with the Liat.  Thanks for that info!

Hi
We have completed the primary validation for respiratory infection in our organization (LifeLabs/Canada). The CT values are comparable to those from the main lab devices (Seegene) for Covid, Flu A/B, and RSV. We are in the process of purchasing 10 Liat-Roche devices for PCR testing. The size is similar to a toaster, and each test will take 20 minutes to complete. Additionally, you can request three tests in one kit. 

Hi Alex

Hello. I am replying with respect to your inquiry about BioFire. In full disclosure, I am a sales representative for the bioMerieux BioFire SPOTFIRE instrumentation. I am based in NY and I am not your account executive. The BioFire SPOTFIRE instrument is a fully FDA Cleared NON-EUA CLIA Waived PCR instrument offering a true 16 minutes 38 second result after 1.5 minute hands on process. The full size paper result can be wireless printed if needed and the system itself has a footprint of 8.5" x 12", about the size of a sheet of paper. It can be scaled vertically to run between 1 and 4 patients at a time. 

There is a new CLIA Waived Panel called RST Mini. RST stands for Respiratory Sore Throat and depending on the type of swab/specimen location, you can obtain a different set of results. 

Using a NP swab and selecting that option on the instrument you will obtain the results for Flu A, Flu B, SARS-CoV-2, RSV, and Rhinovirus. We are expecting to receive Nasal Swab approval sometime in 2025.

Using a Throat Swab and selecting that option on the instrument, you can obtain results for Strep A, Flu A, Flu B, RSV, and Rhinovirus. All of these viral pathogens have a Sore Throat presentation.

We include Rhinovirus because it is the most prevalent viral pathogen during respiratory season and its inclusion can help aid in preventing unnecessary antibiotic prescriptions. We also offer a 15 pathogen bacterial and viral panel with an expanded syndromic approach but eh RST Mini is the most popular.

SPOTFIRE can be integrated into your LIS/EMR through interfacing directly or with the use of middleware. 

We can also include at no additional charge, FIREWORKS, which is a cloud based data portal. You can remotely access all instrumentation from a phone, tablet, or laptop and review, download, and email results, review QC, get an accurate view of the number of tests run, and my favorite, pathogen surveillance. You can look back at 1 day, 1 week, or 4 weeks and with a simple hover obtain the positives detected for that time period. As well, we do not limit the number of licenses so your staff, and whoever you give access to, can obtain this information as well.

I hope this reply is not against the site rules. Please feel free to contact me directly with any questions here or at bruce.applebaum@biomerieux.com

thank you Bruce for the detailed BioFire introduction. Would be great to have a nasal swab option for Flu A, Flu B, SARS-CoV-2, RSV, and Rhinovirus, since Liat and Cepheid have this option available (Liat just was approved, not ready for delivery yet).

Alexandr,

We have listened to our customers and will hopefully be getting the Nasal Swab indication in 2025. Due to our 15 pathogen RST Panel having pertussis and additional bacterial pathogens, a nasopharyngeal swab was required. When we submitted for the full CLIA Waived status for RST Mini, we went with the NP swab so we can supply this product as non-EUA and bring it to the market faster. That being said, if SARS-CoV-2 is not a consideration, the Sore Throat Oral Swab portion of RST Mini may be of use.

Thank you again for your reply.