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Hologic’s Panther Fusion MRSA Assay Lists ESwab™ as Approved Sample Collection Device

Product Validations

September 18, 2018

On July 5, 2018 Hologic, Inc. (Nasdaq: HOLX) announced in a press release that its assay, Panther Fusion® MRSA, received CE-mark in Europe. The latest addition to their Panther Fusion automation comes in response to the rise of antibiotic resistance in Europe. This new assay quickly identifies instances of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) DNA.  European customers looking to implement the new assay will be pleased to learn that ESwab™ is an approved collection and transport device for the Panther Fusion® MRSA assay.

What is ESwab™
COPAN’s Liquid Based Microbiology line, includes Eswab™, SnotBuster™, FecalSwab® and UriSponge™, and it helps laboratories all over the world to streamline and simplify specimen collection and transport. ESwab™ comprises of 1 mL liquid Amies transport media and one flocked swab (FLOQSwab®), COPAN’s proprietary, patented collection device. A flocked swab comprises of a pre-molded plastic applicator with nylon fibers sprayed onto the tip.  With no inner core to trap specimen, the entire sample is eluted into the transport media. This superior elution means ESwab™ packs a big punch when it comes bacterial recovery and allows for up to ten different tests from just one sample.

Why ESwab™
COPAN’s universal collection and transport system is suitable for automation, Gram stains and traditional culture. In addition, assay platforms for molecular and rapid antigen tests are qualifying ESwab™.  This benefits laboratories all over the world as they can use the multipurpose system for many applications. ESwab™ is the first liquid-based multipurpose collection and transport system that maintains the viability of aerobic, anaerobic and fastidious bacteria at both room and refrigerator temperatures for up to 48 hours. Due to the unparalleled benefits in the Microbiology laboratory, assay manufacturers alike are flocking to qualify ESwab™.

ESwab™ with Panther Fusion® MRSA
The following directions have been taken directly from the package insert. To view the full package insert, click here.

A. Work Area Preparation
1. Wipe down work surfaces with 2.5% to 3.5% (0.35 M to 0.5 M) sodium hypochlorite solution. Allow the sodium hypochlorite solution to contact surfaces for at least 1 minute and follow with a deionized (DI) water rinse. Do not allow the sodium hypochlorite solution to dry. Cover the bench surface with clean, plastic-backed absorbent laboratory bench covers.

B. Reagent Preparation
1. Remove the IC-X, FCR-X and FER-X bottles from storage.
2. Open the IC-X, FCR-X and FER-X bottles, and discard the caps. Open the TCR door on the upper bay of the Panther Fusion system.
3. Place the IC-X, FCR-X and FER-X bottles in the appropriate positions on the TCR carousel.
4. Close the TCR door.
Note: The Panther Fusion system adds IC-X to the FCR-X bottle. After IC-X is added to FCR-X, it is referred to as wFCR-X. If wFCR-X and FER-X are removed from the system, use new caps and immediately store according to the proper storage conditions.

C. Specimen Handling
1. Vortex each specimen for 5 seconds. Do not invert tube.
2. Remove the tube cap and swab from the tube.
3. Discard the tube cap and swab according to laboratory procedures.
4. Place a penetrable cap onto the tube.
5. Inspect specimen tubes before loading into the rack. If a specimen tube contains bubbles or has a lower volume than is typically observed, gently tap the bottom of the tube to dislodge bubbles and bring contents to the bottom.
Note: To avoid a processing error, ensure the specimen volume is greater than 500 μL. There is sufficient volume to perform 2 Panther Fusion reactions from a specimen collected with the ESwab collection kit.

D. System Preparation
For instructions on setting up the Panther Fusion system including loading samples, reagents, assay cartridges and universal fluids, refer to the Panther Fusion System Operator’s Manual.

More Assays with ESwab™

Hologic’s Panther Fusion® MRSA is CE-marked in Europe, and many US assay manufacturers have chosen to endorse the use of ESwab™ as an approved collection and transport device. Below is a list of the growing number of assay manufacturers that have been validated with the use of ESwab™ on their platforms:

  • Alere i Strep A
  • BD Veritor System CLSI for Rapid Detection of Group A Strep
  • Cepheid GeneXpert Xpert MRSA NxG
  • Cepheid Xpert Strep A POC
  • Diasorin Simplexa™ Group A Strep Direct
  • Meridian illumigene Pertussis
  • Quidel Solana GAS Assay
  • Quidel Lyra Direct Strep Assay
  • Quidel AmpliVue GAS Assay
  • Quidel Solana Bordetella Complete
  • Roche cobas Liat Strep A

ESwab™ for Everyone
The number of manufacturers qualifying the use of ESwab™ on their assays is growing and does not show any signs of slowing down. This is great news for current users as they adopt new assays.  The ability to use the ESwab™ with multiple assays helps cut down on laborious validation processes and streamlines and reduces the number of catalog part numbers within the laboratory. Sites that are looking to switch to the ESwab™ will also reap the benefits of its expanded testing capabilities!

To try a free sample of ESwab™ contact us today!