BD Veritor Test Systems

Hi Alexis, we went through the same thing with some of our ambulatory sites.  When I called BD, I got this response: 
 Thank you for calling BD Tech Services, it was a pleasure talking to you today! 
 
 I am sorry to hear that some of your locations do not follow our IFUs when running their BD Veritor™ Plus Analyzer tests. To go over our discussion and help your employees to better understand the science behind our Veritor System, please see the below explanation.
 
All BD Veritor™ Plus test results must be determined using the BD Veritor™ Plus Analyzer, otherwise the results cannot be considered valid. Please see Instructions For Use "Warning And Precautions", the document is attached for your convenience. Per our claims:
 
The BD Veritor™ System consists of a dedicated opto-electronic interpretation instrument and immunochromatographic assays for the qualitative detection of Antigens from pathogenic organisms in samples processed from respiratory specimens. 
 
When specimens are processed and added to the test device, the Antigens present in the specimen bind to Antibodies conjugated to micro detector particles in the test strip. The Antigen-Conjugate complexes migrate across the test strip, (for a very certain, calculated amount of time - 5, 10, 15 minutes, depending on the assay) - to the reaction area and are captured by a line of Antibodies bound on the membrane. Therefore, it is important to keep to the timeframe indicated in the IFU for your test to be able to rely on the obtained result.
 
A positive result is determined by the BD Veritor™ Plus Analyzer when Antigen-Conjugate is deposited at the Test “T” position and the Control “C” position on the assay device. 
 
The instrument analyzes and corrects for non-specific binding and detects positives that are not recognized by the unaided eye to provide an objective result.
 
An Analyzer and a kit were developed to function together as a testing System, therefore using only a kit without an Analyzer brings the user outside our claims (considered as "off-label use") and may cause reporting false results, be it Negative or Positive.
 
Please DO NOT read BD Veritor™ tests visually, and make sure to use your Analyzer to determine the test results.
 

Hi Alexis,

I had this happening at my satellite emergency department. We are currently working on getting these analyzers interfaced so whatever the analyzer reads is what will result in the patients chart. The current process is that if they are questioning results to send another test to our main laboratory for confirmation. Normally, the main lab results the same as what the analyzer produced. I have definitely had instances where something looks positive on a cartridge to the naked eye. I find it as interesting as the staff running it. 

we used to have this system and we also had different results read on two different readers one positive and one negative and one where if they put the cartridge in twice one right after the other they got different results one time too. The only thing I could encourage was to make sure they were using the up to date readers since they upgraded during covid and stress not reading them manually since it was off label use per the manufacturer. but that did not help their confidence levels in the test system.