Rapid Strep Correlation Study
Hello,
Currently in our practices we use a variety of rapid strep tests. It was our intention to move to molecular next year at some point to prevent having to send negative results out for confirmation and to standardize our practices. After meeting with a reputable vendor, it was brought to my attention that there is a high risk of contamination with molecular based strep tests and many labs are refusing to add molecular to their current licensure because of this. It was recommended that I perform a correlation study with the rapid strep test of interest, compared to the rapid test most commonly used in our offices, and compared to the lab. By doing so, I can provide the info to our accrediting body and if sufficient evidence is found, this would alleviate having to send out for negative results. Has anyone performed a similar study?
Thanks in advance!
Raychel Rusnak
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A new rule says that negative results from pediatric patients
must be confirmed by a laboratory method. If you test patients under 18, then you cannot eliminate the lab culture.
Raychel,
What is your email and contact information? I can have our Microbiologist, specialized in molecular testing, talk with you about this.
Thanks!
Jeremy Williford, PBT(ASCP)CM
Laboratory Services Coordinator
Laboratory
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South Georgia Medical Center
2501 North Patterson Street
Valdosta, Georgia 31602
229-433-4804 (O) | 229-563-2292 (M)
jeremy.williford@SGMC.ORG | sgmc.org
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From: Raychel Rusnak via POCT Listserv (Groupsite)
Sent: Wednesday, December 11, 2019 1:55 PM
To: Williford, Samuel 'Jeremy'
Subject: [POCT Listserv] Rapid Strep Correlation Study
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Terry, what is your source for the new rule that says patients under 18 must be confirmed by lab culture?
Raychel,
In no way am I against reputable vendor reps giving advice/suggestions related to POC Products and instruments. That's how most of us find out about new products or studies others have done, white papers, etc. What I am going to say is not related to your info coming from a vendor rep.
If the vendor rep who advised you about POC molecular being a source of contamination is not themselves representing a waived testing molecular/PCR instrument, then please also consider that there are other reasons to convert from a rapid to a waived testing molecular instrument. I'm not suggesting that rapids should all be tossed away as clearly there is a huge jump in cost to switch to molecular/PCR. At least discuss with your MDs the other benefits before deciding to stick with a rapid test.
On comparing rapid tests in a side by side, also consider if one is a product where the operator reads 'lines' or if one of them has a 'reader' so no visual reading of 'lines' by the operator. For us before we transitioned to WT molecular/PCR, using a rapid with a reader was a huge uptick in how we felt about getting a 'better' patient result. Just an observation I wanted to share.
If you are describing doing a side by side of a molecular/PCR instrument and a rapid, then yes, we have done studies through clinical micro. The first author's name is Greg Berry.
Good Luck, Peggy
If you run Stat Strep testing under CAP, there is a standard that all pediatric patients must have a culture when stat strep results are negative. Although our package insert does not specifically say "must" run a culture, there is a strong statement from the American Academy of Pediatrics recommending culture. With that reasoning in mind we have switched our practice from culturing all patient negatives to requiring a culture on all negative results from pediatric patients.
Thank you all for responding. All of our offices performing strep testing are CLIA waived.
We would be performing the strep correlation on the same analyzer that currently reads our influenza test. We want to do away with manual reading of the strep cartridges and either move to POC molecular or rapid with the reader. Of course the ultimate decision of will come from our lab directors that hold the CLIA licenses but I will be the responsible person for carrying out this study.
We've had no problems with cross contamination. Before going live with the Alere i (rebranded as Abbott ID NOW) molecular test system in Jan 2019 I conducted risk assessment and verification experiments (NATtrol respiratory verification panel). The risk assessment revealed areas where cross contamination may occur. To minimize these risk we train our operators in good molecular technique. This includes but is not limited to the following:
hi Terry and Stephanie, can you tell me where the new rule/standard is stated regarding confirmation? I may have overlooked it!
Hello Anna,
Here is the requested POC CAP standard you are requesting.
POC.04575 Group A Strep Direct Antigen Detection
NOTE 1: Policies must be established for the use of cultures or other confirmatory tests on pediatric specimens that test negative when using antigen detection methods or if the manufacturer's guidelines include recommendations for culture follow-up. These policies should take into account the sensitivity of the assay in use, the age and clinical presentation of the patient, and other factors.
NOTE 2: Direct antigen tests should be performed and reported in a timely fashion, since their principal advantage (compared culture) is rapid turn-around-time.
Best,
Cherlyn Bynum
PPMC
POC.04575
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Hi,
I don’t think this question mandates the use of follow up culture for PCR/NAAT testing. As long as your manufacturer does not require confirmation and your
method validation proves what the manufacturer claims. You write that into your procedure and you should be okay. We do not set up cultures to validate negative Alere I NAAT Strep A tests.
Reine
Children's Wisconsin
Point of Care Team Lead
Phone: 414-266-6624
Fax: 414-266-3518
Email: rmakiya@chw.org
From: Cherlyn Bynum via POCT Listserv (Groupsite) [mailto:users+1160479@poct.groupsite.com]
Sent: Tuesday, December 17, 2019 9:31 AM
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Subject: [POCT Listserv] Re: Rapid Strep Correlation Study
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The Alere i/Abbott ID NOW NAAT serves as our Strep A confirmation test for negative antigen tests.
Per CAP POC.04575 this does not apply to molecular testing, only direct antigen testing.