INTRODUCTION

The coronavirus (CoV) belongs to the order Nidovirales under the family Coronaviridae with 4 genera: α, β, γ, and δ. The genera α and β are pathogenic only for mammals, while genera γ and δ mainly cause infections in birds. CoV is mainly transmitted through direct contact with secretions or by aerosols and droplets. There is also evidence for fecal-oral transmission. So far, 7 types of human coronaviruses (HCoV) have been identified that cause respiratory diseases in humans, including: HCoV-229E, HCoV-NL63, HCoV-OC43, HCoV-HKU1, SARS-CoV, MERS-CoV, and SARS-CoV-2. SARS-CoV-2 is one of the most contagious viral pathogens that cause human respiratory infections (RTI). Currently, patients who are infected with SARS-CoV-2 are the main source of infection. Asymptomatic infected people can also be a source of infection. According to current epidemiological investigations, the incubation period is 1 to 14 days, mostly 3 to 7 days. Clinical symptoms include fever, fatigue, cough, and other symptoms, accompanied by shortness of breath, which can quickly progress to severe, life-threatening pneumonia, respiratory failure, acute respiratory distress syndrome, septic shock, multiple organ failure, and severe metabolic acid-base imbalance.

Respiratory syncytial virus belongs to the Pneumovirus genus of the Paramyxoviridae family. It can be transmitted through the air and through close contact, mainly causing lower respiratory tract infections such as bronchiolitis and pneumonia in infants under 6 months old, and upper respiratory tract infections such as rhinitis and colds in older children and adults. Clinically, patients with respiratory syncytial virus infection can present with fever, nasal congestion, dyspnea, and even respiratory failure or heart failure when the symptoms are severe, requiring active treatment.

Adenovirus (ADV) is an unenveloped DNA virus that mainly infects a wide variety of vertebrates, including humans. Human infection can lead to a variety of clinical manifestations and diseases, including respiratory diseases (such as the common cold, bronchitis, pneumonia, etc.), digestive tract diseases (such as diarrhea, gastroenteritis, etc.), conjunctivitis, and cystitis. Individual cases can become severe and critical, and even result in death.

Mycoplasma pneumoniae (M. pneumoniae) is the causative agent of mycoplasma pneumonia in humans. The pathological changes of mycoplasma pneumonia are mainly interstitial pneumonia, sometimes complicated by bronchopneumonia, which is called primary atypical pneumonia. The infection is mainly transmitted by droplets. The incubation period is 2 to 3 weeks, and the incidence is highest in adolescents. The clinical symptoms are mild, or even absent, and if present, they include general respiratory symptoms such as headache, sore throat, fever, and cough. There have been reports of deaths associated with the infection. It can occur throughout the year, but is most common in autumn and winter. Influenza, commonly referred to as the flu, is an acute respiratory infection caused by the influenza virus. It is highly contagious and is mainly transmitted by coughing and sneezing. Outbreaks usually occur in spring and winter. Influenza is mainly divided into influenza A and influenza B viruses. Influenza A viruses are highly variable, followed by influenza B viruses. Therefore, Influenza A viruses are more common and severe, followed by influenza B viruses. Influenza A includes H1N1, H3N2, H5N1, H7N9, and influenza B includes influenza B (Victoria) and influenza B (Yamagata).

INTENDED USE

This kit is only used for the in vitro qualitative detection of Multiple Respiratory Multipathogen Antigen (SARS-CoV-2/Respiratory Syncytial virus/Influenza A virus/Influenza B virus/Adenoviruses/M. pneumoniae) from human nasopharyngeal swab specimens. The SARS-CoV-2/RSV/ADV/MP & Flu A/B Antigen Rapid Test Kit is an immunochromatographic double-antibody sandwich assay intended for the qualitative detection and differentiation of SARS-CoV-2/Respiratory Syncytial virus/Influenza A virus/Influenza B virus/ Adenoviruses/M. pneumoniae in individuals suspected of respiratory tract disease infection. This kit is suitable for the auxiliary diagnosis of respiratory diseases; the results are for clinical reference only and cannot be used as the sole basis for diagnosis and exclusion decisions. The clinical diagnosis and treatment of patients should be considered in combination with their symptoms/signs, medical history, other laboratory tests, and treatment responses. A positive test result needs to be further confirmed; a negative result does not exclude respiratory diseases or viral infections.

PRINCIPAL

The kit is immunochromatographic and uses latex microspheres method to detect SARS-CoV-2/Respiratory Syncytial virus/Influenza A virus/Influenza B virus/Adenoviruses/M. pneumoniae. During detection, the treated specimens are loaded into the sample wells of the test card. When the concentration of SARS-CoV-2/Respiratory Syncytial virus/Influenza A virus/Influenza B virus/Adenoviruses/M. pneumoniae in the specimen is higher than the minimum detection limit, the viral antigen will form complexes with labeled antibodies first. Under chromatography, the complexes move forward along the nitrocellulose membrane until they are captured by pre-coated monoclonal antibodies of SARS-CoV-2/Respiratory Syncytial virus/ Influenza A virus/Influenza B virus/Adenoviruses/M. pneumoniae in the detection zone on the nitrocellulose film (COV/MP/RSV/ADV/A/B) to form a blue reaction line on the detection zone. At this point, the result is positive. Conversely, if there is no viral antigen or the concentration of the antigen in the specimen is below the minimum detection limit, no blue reaction line appears in the detection zone, and the result is negative. Regardless of whether the sample contains viral antigens or not, a blue reaction line will appear in the quality control zone (C). The blue reaction line that appears in the quality control zone (C) is the criterion for determining if the chromatography process is normal.

WARNINGS AND PRECAUTIONS

• This test kit is for in vitro diagnostic use only.
• This test kit is intended for persons aged 18 and over.
• Bring the contents of the kit to room temperature before testing.

• Appropriate protection should be worn while performing the test to avoid splashes when adding the sample.
• If the SARS-CoV-2 test is positive, there is a suspicion of a COVID-19 infection, contact your doctor/GP immediately or the local health department, follow local guidelines Self-isolate and perform a confirmatory PCR test.

• If the result of the ADV, RSV, MP, influenza A/B test is positive: There is currently the Suspected ADV, RSV, influenza A/B, MP infection and what to do next be undertaken according to local guidelines.

• Do not reuse the test kit.
• Do not use the test kit if the pouch breaks the seal broken or the test cassette is wet or dirty.
• Do not use the contents of the test kit after the expiry date on the expiry date printed on the outside of the packaging.