Post-market evaluation of serology-based point of care tests

  1. 3,244 Posts.
    lightbulb Created with Sketch. 313
    https://www.tga.gov.au/post-market-evaluation-serology-based-point-care-tests

    SARS-CoV-2 Antibody Test (Lateral Flow Method) (Guangzhou Wondfo Biotech Co Ltd, China)

    The overall total antibody sensitivity and specificity claimed by the manufacturer in the IFU provided with the device is 86.43% and 99.57% respectively (note this device does not distinguish between IgM and IgG results).

    The overall total antibody sensitivity of the device when tested by the Doherty Institute was found to be 68.6% while the total antibody specificity was found to be 97.8%. For samples collected 14 days post onset of symptoms the overall sensitivity improved to 93.8%.

 
Add to My Watchlist
What is My Watchlist?
A personalised tool to help users track selected stocks. Delivering real-time notifications on price updates, announcements, and performance stats on each to help make informed investment decisions.
(20min delay)
Last
0.4¢
Change
-0.001(20.0%)
Mkt cap ! $1.985M
Open High Low Value Volume
0.4¢ 0.4¢ 0.4¢ $120 30K

Buyers (Bids)

No. Vol. Price($)
8 7743693 0.4¢
 

Sellers (Offers)

Price($) Vol. No.
0.6¢ 400000 1
View Market Depth
Last trade - 09.59am 01/07/2025 (20 minute delay) ?
AN1 (ASX) Chart
arrow-down-2 Created with Sketch. arrow-down-2 Created with Sketch.