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Evaluation on the Specificity and Sensitivity of a COVID-19 and A+B Influenza Antigen Combo Test for Detection and Application in Rapid Chromatographic Immunoassays.

Zhang Lei*, Yang Feng and Zhu Junzhe

Background: The emergence of COVID-19 and influenza A+B antigen combination diagnostic tests implies a significant increase in their respective prevalence worldwide [1] On the one hand, the emergence of novel coronary pneumonia has had a significant impact on people's lives worldwide since 2019. As a condition consisting of severe acute respiratory syndrome with a high intensity of transmission, COVID-19 poses a threat to human health worldwide. On the other hand, influenza A, which dominates influenza, has increased in activity worldwide.

As of December 14, 2022, the cumulative number of COVID-19 confirmed cases worldwide reached more than 640 million. Of these, 260 million and 180 million have been confirmed in Europe and the Americas, respectively. The number of confirmed cases worldwide will reach a peak in January 2023. In addition, it is estimated that more than six million people worldwide have died from COVID-19. However, this figure is incomplete and to some extent, the data for Africa is not complete and the presence of asymptomatic patients makes it difficult to count. For influenza, North America and Europe have seen a significant increase in influenza activity, while other regions have seen a relatively lower prevalence [4]. In the National Influenza Centre (NIC) study, 97.9% of the 562,000 samples were influenza A viruses, while influenza B viruses accounted for 2.1%.

In clinical manifestations, patients infected with novel coronaviruses mainly present with fever, malaise and dry cough, and some people suffer from a stuffy, runny nose, sore throat, and myalgia diarrhea. The incubation period of the novel coronavirus is 1-14 days, with most people developing symptoms within 3-7 days? In addition, the novel coronavirus is highly contagious and can be transmitted to asymptomatic people. Influenza is also a highly contagious acute respiratory virus that can be transmitted from person to person through droplets containing the virus, such as coughing and sneezing, resulting in infection.

Objective: The main objective of this report is to evaluate and discuss how the COVID-19 and influenza A+B antigen combo tests can be used in practical situations and to analyse their professional performance in terms of response principles and accuracy. The feasibility of its application as a major tool for the rapid diagnosis of COVID-19 and influenza A+B antigens will also be reviewed.

Method: The SARS-CoV-2 nucleotide protein and influenza A + B virus antigens are detected in nasopharyngeal swabs from infected patients by rapid chromatographic immunoassay for the detection of COVID-19 and influenza A+ B viruses in the nasopharynx. As their antigens can be detected during the acute phase of infection, a positive result indicates the presence of antigens in the nasopharynx of the patient, while a negative result does not exclude the possibility of infection and should be confirmed by combining the test results with clinical signs of exposure and presence of associated symptoms in the patient.

Results: The results showed that the ACRO Rapid Test for COVID-19 and A + B influenza antigen combo (nasal swabs) achieved a sensitivity of 97.7%, specificity of 99% and accuracy of 98.6% for the COVID-19 antigen. The sensitivity for Type A influenza was 97%, the specificity 99.4% and the accuracy 99.2%. For Type B influenza, the sensitivity was 94.6%, the specificity 99.4% and the accuracy 99%.

Conclusion: The ACRO COVID-19 and Influenza A+B Antigen Combo (Nasopharyngeal Swab) is a qualitative, membrane-based immunoassay that tests for SARS-CoV-2 nucleotide protein and influenza A and B nucleoproteins by detecting the presence of antigenic viruses in the nasal cavity of a sample using a lateral flow immunoassay, a convenient and rapid test that gives results in less than 15 minutes.

The combination of COVID-19 and influenza A+ B antigen is easy to handle and tests for both antigenic viruses simultaneously with clear and understandable results. In this sample test, the antigen combination can effectively help patients to determine if they have this antigenic virus, and its accuracy and specificity have been thoroughly tested. Patients can use the rapid test kit to make a rapid diagnosis and get a specific assessment of which virus or viruses they are infected with.


COVID-19; Influenza A+B; Antigen; Rapid Test

Published Date: 2023-01-31; Received Date: 2023-01-03