Authors
Achim Wolf, Jack Hulmes, Susan Hopkins

Lateral flow device specificity in phase 4 (post marketing) surveillance

publication date
10 March 2021
Category
see more

Abstract/Introduction

Public Health England (PHE) and Oxford University evaluated the performance of the

Innova LFD device against PCR. In phase 2 and 3a, where the same sample was used for

both PCR and LFD specificity analyses, no false positives were detected. We conducted a

Phase 4, post marketing surveillance study in 7,546 individuals with a negative PCR result

and compared those results with the LFD results from a separate sample. This study

identified 21 (0.28%) discordant test pairs and therefore concluded that the specificity of

the LFD device was 99.72%. However, this analysis assumed a sensitivity for the PCR of

100% (i.e. that on all 21 discordant samples the PCR, and not the LFD, gave the correct

result). Analysis of the Phase 4 data can also be interpreted with lower PCR sensitivity

levels and is consistent with a PCR sensitivity ranging from 94.2% to 100% and an

associated LFD specificity ranging from 100% to 99.72%


Conclusion/Results

These analyses support the policy of not requiring PCR confirmation of positive LFDs

conducted at ATSs under current levels of population prevalence. The data will be kept

under review and further post marketing surveillance analyses conducted at regular

intervals.


Testimonials


  • Vision therapy is well worth the response, time and effort. Our Son had a hard time focusing and writing neatly. After vision therapy Seth could complete a task in half the time if previously took. His abilities to focus improved greatly and so did his handwriting.

    Also, he was better at listening. As a parent, we wanted learning to be fun for our Son, and vision therapy made this possible.


    Amanda T.

  • Vision Therapy is well worth the expense, time and effort. Our son had a hard time focusing handwriting neatly. After vision therapy Seth could complete a task in half the time it previously took his abilities to focus and improved greatly and so did his handwriting.

    Also, he was better at listening. As a parent you wanted learning to be fun for our son and vision therapy made this possible.


    Alexa H.

  • Vision Therapy has given or son the tools he needs to be able to scan and read the written word more effectively and efficiently.

    He love working with John and these working sessions give him the motivation to gladly work on his homework assignments.

    It amazed us to see the difference in the tracking of his eyes and along a line of it's from the beginning to the end of the treatment.

    Dr. McBryar , Kristen and John  are all marvelous and we would recommend them to anyone I only wish that we would have found them sooner!


    Charlotte M.

  • Prior to coming to the institute for vision development my son complained of daily headaches. Therapy has eliminated his headaches completely. I love knowing my son is able to learn pain-free for the rest of his life because of the work that has been done over just a few weeks in this office. He he absolutely loved coming that didn't even feel like going to a doctor or therapy. We are grateful for the relief he was able to find by coming here.

    Thank you!


    Olivia C.

  • Seems much less frustrated with life

    Reads non-stop and fast

    Spelling abilities have been hugely improved

    Seems much more confident

    Thank You!!!


    Kelly O.

Blog

group-of-small-nursery-school-children-with-teache-W2UF5RU

Vision Among Us

One of the challenges with visual impairments and visual deficits is that it's difficult to detect them just by looking […]

Read More
frustrated-millennial-businessman-having-strong-headache-tired-from-laptop-work

Vision Therapy for Neurological Conditions

Each year an estimated 1.5 million Americans sustain a traumatic brain injury (TBI). According to the Neuro Optometric Rehabilitation Association, […]

Read More
DSC_2077

Vision Therapy for Adults

Adults generally accept changes in themselves as part of aging, and think that there's nothing they can do about it. […]

Read More
see all blogs

Contact Us To Amplify Your EyeCare

Working Hours

Monday - Thursday
8:00 am - 5:15pm
friday-sunday
Closed
Location
1043 Executive Drive Suite #101 Hixson, TN 37343
Website Accessibility Policy
Safety protocols page
phone-handsetarrow-uparrow-right linkedin facebook pinterest youtube rss twitter instagram facebook-blank rss-blank linkedin-blank pinterest youtube twitter instagram