Rapid Strep
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Does anyone run waived Rapid Strep testing in their main laboratory or is it utilized strictly as a POC test at your facility and do you require confirmatory cultures on all negative results regardless of age?
Any feedback is appreciated
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We run waive rapid strip both in the lab and as POCT. We DO reflex to a confirmatory culture on all negative rapid streps…both in lab and POCT.
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We run Group A strep POC and in the Main Lab. All negative screens (regardless of age) are supposed to have confirmatory culture. My POC site is very compliant with this; a rare culture not performed-usually patient refusal or physician specifying no culture.
We do POC strep testing. All negatives are supposed to go for a confirmatory lab swab. In NYS we are challenged as the provider needs to order the lab, and often they decide not to do so. I believe it is a CMS requirement to confirm negatives
regardless of age
Our current method requires the confirmation. However, Alere i gained FDA approval for not requiring the confirmation culture. We are looking at moving to the
Alere i for Lab and POC Rapid Strep testing.
We perform Rapid Strep testing at both POCT and in our hospital labs. Regardless of age at our facilities, all negative rapid screens are reflexed currently to PCR strep testing.
At a minimum you will need to comply with the rapid test kit manufacturers instructions. Any reference to "recommendation that negative rapid screen result be confirmed by...." your accreditation agency should be inspecting the recommendation as "required".
the Cepheid GeneXpert instrument running PCR C.Diff and MRSA etc. in many of your labs, is now also available as a Point of Care CLIA waived instrument - running StrepA, and Flu and will run Flu/rsv later this year - FDA approved to not require culture confirmation.
This depends on the accreditation agency. CMS/CLIA inspectors will not see recommendations as requirements(instructions), nor will CAP. CAP will require that all "pediatric" negatives be confirmed, but it is up to the testing site to define what a pediatric patient is. Here, we are CAP and have defined an age limit on pediatric patients, and kept logs showing that the negative test results are being confirmed.
We perform Rapid Strep (antigen) testing only in main lab and reflex to throat screen culture if negative. We use the double-swab collection kit so there is always a second swab to use for culture. I think cancellations of the confirmatory culture are rare, but when we were responsible for physician office labs/clinics, the physicians would often opt to decline the culture - often based on the patient's ability to pay.
Double swab collection is great, but those swabbing need to collect more specimen to ensure a good poc test. Otherwise, you increase the chance of a false negative. Also, make sure the double collection swabs are compatible with your POC
test. Swabs may be foam, rayon or polyester. I always teach staff to use the swab from the POC kit with
one from the collection tube together, and rotates swabs during the collection to ensure all sides are covered.
Debra Galatioto MSN, RN
Assistant Director of Nursing- Education & Infection Control
Hudson Headwaters Health Network
9 Carey Road, Queensbury NY, 12804
(518) 761-0300 Ext. 31122
(518) 222-3447 Mobile
dgalatioto@hhhn.org
www.hhhn.org
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I have been searching around and it looks like Cepheid and Alere i are the only 2 tests that do not require confirmation on negatives. Am I missing any others?
I am looking for a waived test without the need for confirmation testing. Right now we use Quidel for POC testing but it requires confirmation.
The Roche Liat Strep A does not need confirmation.