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

N/A

106

N/A

75.7 (67.8 to 82.6)

N/A

N/A

109

N/A

77.9 (70.1 to 84.4)

N/A

N/A


Ct >30 ≤36

60

N/A

55

N/A

92.3 (83.0 to 97.5)

N/A

N/A

22

N/A

36.7 (24.6 to 50.1)

N/A

N/A

21

N/A

35.0 (23.1 to 48.4)

N/A

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 

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