Warning over ‘faint’ COVID-19 test kit results

Warning over ‘faint’ COVID-19 test kit results

Users of a particular COVID-19 test have been warned to take faint lines seriously in a notice from the Therapeutic Goods Administration.

The TGA said the makers of Fanttest COVID-19 test kits had been made aware of the potential for the kit to display positive test lines of varying faintness.

Users are warned that a faint line appearing in the “control” (C) section is still an indication of a strong positive test for the virus.

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“The Instructions for Use (IFU) state that a valid result occurs when a coloured line appears in the control region (C),” the TGA said in its online notice.

“There is no mention that there is potential for variability in the appearance of the control line.

“However, where strong COVID-19 positive results are obtained there is potential for a faintly appearing control line.

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“This has caused customer confusion and possible misinterpretation that the test result is invalid when it is actually a valid positive result.”

The TGA said the manufacturer had updated the IFU for batches manufactured after February 2024 to include information about the potentially faint appearance of the control line.

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