New Product Launch Notice - AQ+Covid-19 Ag Rapid Test-intecasi.com

New Product Launch Notice - AQ+Covid-19 Ag Rapid Test Jan 28, 2022

InTec, a global leading IVD company specialized in infectious disease diagnostics with a focus on screening at the point of care, today announced the launch of anovel ultra- sensitive SARS-CoV-2 Rapid Antigen Test –AQ+ Covid-19 Ag Rapid Test for professional use.

TheAQ+ Covid-19 Ag Rapid Testis intended for use by healthcare professionals or laypersons to rapidly and conveniently detect Covid-19. The test is compatible with nasopharyngeal, nasal, and saliva samples, providing reliable results within 15 minutes. It is also designed for testing symptomatic and asymptomatic individuals, providing high sensitivity even in patients with low viral loads.

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 -Virology Laboratory, Infectious Diseases Division (IDD) icddr,b, Dhaka, Bangladesh, demonstrated97.0% sensitivity and 100% specificity when compared with sensitivity of PanbioTMand CareStartTMkits as 64.0% and 65.0% respectively on a clinical study of 300 subjects. Regarding the Ct values, AQ+ Covid-19 Ag Rapid Test has shown ultra-high sensitivity as 99.3% when Ct ≤30, and still going strong as 92.3% when 30

In summary, the InTecAQ+COVID-19 Ag Rapid Testshowed strong performance in detecting COVID-19 cases. Equipped with ultra-high sensitivity, the AQ+Rapid Antigen test kits can be used as a large-scale screening tool,testing of patients with low viral loads, and as anaid in the diagnosis of COVID-19 infection in both symptomatic and asymptomatic individuals.

Rapid antigen kits vs rRT-PCR

Real time RT-PCR (ORF1ab)

InTec AQ+COVID-19 Ag Rapid Test

PanbioTMCOVID-19 Antigen Rapid Test

CareStartTMCOVID-19 Antigen Test

Positive

Negative

Positive

Negative

Sensitivity(95% CI)

Specificity(95% CI)

Accuracy(95% CI)

Positive

Negative

Sensitivity(95% CI)

Specificity(95% CI)

Accuracy(95% CI)

Positive

Negative

Sensitivity(95% CI)

Specificity(95% CI)

Accuracy(95% CI)

Ct ≤30

140

N/A

139

N/A

99.3 (96.1 to 100.0)

N/A

106

N/A

75.7 (67.8 to 82.6)

N/A

109

N/A

77.9 (70.1 to 84.4)

N/A

Ct >30 ≤36

N/A

92.3 (83.0 to 97.5)

N/A

36.7 (24.6 to 50.1)

N/A

35.0 (23.1 to 48.4)

N/A

Overall

200

100

194

100

97.0

(93.6 to 98.9)

100.0

(96.4 to 100.0)

98.0

(95.7 to 99.3)

128

100

64.0 (56.9 to 70.7)

100.0

(96.4 to 100.0)

76.0

(70.8 to 80.7)

130

100

65.0 (58.0 to 71.6)

100.0

(96.4 to 100.0)

76.7

(71.5 to 81.3)

AQ+COVID-19 Ag Rapid Testvs rRT-PCR in all Ct ranges

Type of sample		rRT-PCR (ORF1ab)
		Positive	Negative
AQ+COVID-19 Ag Rapid Test(nasopharyngeal specimen)	Positive	194	0
	Negative	6	100
	Total	200	100
Sensitivity	97.0% (95% CI:93.6% to 98.9%)
Specificity	100.0% ((95% CI:96.4% to 100.0%)
Accuracy	98.0% (95% CI:95.7% to 99.3%)

PanbioTM COVID-19 Antigen Rapid Testvs rRT-PCR in all Ct ranges

Type of sample		rRT-PCR (ORF1ab)
		Positive	Negative
PanbioTMCOVID-19 Antigen Rapid Test(nasopharyngeal specimen)	Positive	128	0
	Negative	72	100
	Total	200	100
Sensitivity	64.0% (95% CI:56.9% to 70.7%)
Specificity	100.0% (95% CI:96.4% to 100.0%)
Accuracy	76.0% (95% CI:70.8% to 80.7%)

CareStartTM COVID-19 Antigen Testvs rRT-PCR in all Ct ranges

Type of sample		rRT-PCR (ORF1ab)
		Positive	Negative
CareStartTMCOVID-19 Antigen Test(nasopharyngeal specimen)	Positive	130	0
	Negative	70	100
	Total	200	100
Sensitivity	65.0% (95% CI:58.0% to 71.6%)
Specificity	100.0% (95% CI:96.4% to 100.0%)
Accuracy	76.7% (95% CI:71.5% to 81.3%)

Ordering Information

Product	Cat. No.	Format	Pack Size	Specimen*	Certification
AQ+ COVID-19 Ag Rapid Test	ITP16042	Cassette	1T/5T/25T	NP + N Swab	CE
AQ+ COVID-19 Ag Rapid Test	ITP16043	Cassette	1T/5T/20T	Saliva	CE
AQ+ COVID-19 Ag Rapid Test (with negative and positive control)	ITP16044	Cassette	25T	NP + N Swab	CE
AQ+ COVID-19 Ag Rapid Self-Test	ITP16045	Cassette	1T/2T/5T/7T/25T	N Swab	Processing
*Specimen: NP = Nasopharyngeal, N = Nasal

[1] Evaluation of AQ+COVID-19 Ag Rapid Test(nasopharyngeal specimen): Comparison with Real-time RT-PCRVirology Laboratory, Infectious Diseases Division (IDD) icddr,b, Dhaka, Bangladesh 4 November 2021