InTec Ultra High Sensitive AQ+ COVID-19 Ag Rapid Test receives CE mark for self-testing Jul 01, 2022

InTec Ultra High Sensitive AQ+ COVID-19 Ag Rapid Test receives CE mark for self-testing

InTec, a global leading IVD company specialized in infectious disease diagnostics with a focus on screening at the point of care,has announced that itsUltra High Sensitive AQ+ COVID-19 Ag Rapid Testhas been CE marked for self-testing.The test will be available in countries accepting the CE mark, in packs of 1/2/5/7/25 tests.

Leveraging InTec’s proprietary Silicore™ next generation immunochromatography platform, AQ+Covid-19 Ag Rapid Test increases analytical sensitivity up to 25X compared to current leading rapid test brands. The test has been evaluated by InTec partner

Up to 25X increase in analytical sensitivity compared to leading rapid test brands
Ultra-high sensitivity 99.09% and excellent specificity 100%
Potential for testing of patients with low viral loads, aid in the diagnosis of COVID-19 infection in asymptomatic individuals

Performance Characteristics

		Vitassay qPCR SARS-CoV-2		Total
		Positive	Negative	Total
AQ＋COVID-19 Ag Rapid Test	Positive	109	0	109
AQ＋COVID-19 Ag Rapid Test	Negative	1	470	471
Total		110	470	580

Statistic	Value	95% CI
Sensitivity	99.09%	95.04%~99.98%
Specificity	100.00%	99.22%~100.00%
Total coincidence rate	99.83%	99.04%~100.00%

Ordering Information

Product	Cat. No.	Type	Pack Size	Specimen	Certification
AQ+ COVID-19 Ag Rapid Test for self-testing	ITP16045-TC1	Cassette	1T	Nasal swab	CE
	ITP16045-TC2	Cassette	2T	Nasal swab	CE
	ITP16045-TC5	Cassette	5T	Nasal swab	CE
	ITP16045-TC7	Cassette	7T	Nasal swab	CE
	ITP16045-TC25	Cassette	25T	Nasal swab	CE