6 in 1 Common Respiratory Viruses (COVID-19 / Flu A & B / RSV / ADV / MP) Rapid Antigen Test

【INTENDED USE】

The COVID-19/Flu A+B/RSV+MP Antigen Combo Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2, Influenza A+B, Respiratory Syncytial Virus and Mycoplasma pneumoniae Antigen in Nasopharyngeal swab.

【SUMMARY】

COVID-19 Antigen

The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.

FLU A&B Antigen

Influenza (commonly known as ‘flu’) is a highly contagious, acute viral infection of the respiratory tract. It is a communicable disease easily transmitted through the coughing and sneezing of aerosolized droplets containing live virus. Influenza outbreaks occur each year during the fall and winter months. Type A viruses are typically more prevalent than type B viruses and are associated with most serious influenza epidemics, while type B infections are usually milder. The gold standard of laboratory diagnosis is 14-day cell culture with one of a variety of cell lines that can support the growth of influenza virus. Cell culture has limited clinical utility, as results are obtained too late in the clinical course for effective patient intervention. Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) is a newer method that is generally more sensitive than culture with improved detection rates over culture of 2- 23%. However RT-PCR is expensive, complex and must be performed in specialized laboratories. RSV Antigen

Human respiratory syncytial virus (HRSV) is a syncytial virus that causes respiratory tract infections. It is a major cause of lower respiratory tract infections and hospital visits during infancy and childhood. A prophylactic medication, palivizumab, can be employed to prevent HRSV in preterm (under 35 weeks gestation) infants, infants with certain congenital heart defects (CHD) or bronchopulmonary dysplasia (BPD), and infants with congenital malformations of the airway. Treatment is limited to supportive care (e.g. C-PAP), including oxygen therapy. In temperate climates there is an annual epidemic during the winter months. In tropical climates, infection is most common during the rainy season.

Mycoplasma pneumoniae Antigen

M. pneumoniae is one of three species of Mycoplasma that frequently cause infection in humans. M. pneumoniae most commonly causes upper respiratory tract infections, but can also cause pneumonia. The identification of the M. pneumoniae will help the administration of the disease with appropriate antibiotic treatment. This M. pneumoniae immunoassay is intended to detect M. pneumoniae antigen qualitatively. Because this one-step M. pneumoniae rapid test is easy to carry out, it is widely used as a screening test device and as an aid in the diagnostics of M. pneumoniae disease.

【MAIN COMPONENTS】

Rapid Test cassette: The test kit includes Covid-19, Flu A+B, RSV and MP test strips, which are fixed in a plastic device; Extraction Tube and Buffer; Swab; Package Insert Note: The components in the kits of different batch numbers cannot be used interchangeably. Equipment and materials required for testing but not provided: timer, gloves, goggles.

【SAMPLE REQUIREMENT】

Specimens obtained early in the onset of symptoms will contain the highest virus titer; Compared with RT-PCR testing, specimens obtained 5 days after the onset of symptoms are more likely to produce Positive results; Insufficient specimen collection, improper specimen handling and/or transportation may produce false negative results; Do not return the nasal swab to the original swab packaging; Freshly collected specimens should be processed as soon as possible, but no later than 1 hour after specimen collection; The collected specimens can be stored at 2-8°C for no more than 24 hours; Store at -70℃ for a long time, but avoid repeated freeze-thaw cycles; Improper sample handling, storage and transportation methods may produce false negative results.

【OPERATION PROCEDURE】

SAMPLE COLLECTION

This product can be equipped with disposable sampling swabs, sampling is as follows: Nasopharyngeal Sampling: Gently insert the swab head into the nasal cavity and scrape the cavity wall. Immerse the swab head into sample solution and discard the tail of swab.

DETECTION

1. Insert the tip onto tube membrane, take out the tip after membrane’s puncture.

2. Collect the swab sample according to above instruction.

3. Roll the swab at least 6 times while pressing the head against the bottom and side of the extraction tube. Leave the swab into the extraction tube for 1 minute. Squeeze the tube by fingers from outside of the tube to immerse the swab. Remove the swab. The extracted solution will be used as test sample.

4. Put the tip onto the tube, and take out its cap.

5. Add 2 drops of the mixed sample to each sample wells of the cassette and read theresultsin15 minutes.

【PERFORMANCE INDEX】

Sensitivity, Specificity and Accuracy

【PRECAUTIOUS】

1) This product is disposable, please use it within the validity period.

2) Do not use the aluminum foil bag if it is found to be damaged. Please use it as soon as possible after opening the aluminum foil bag.

3) All testing work must comply with the provisions of the Biosafety Code and strictly prevent cross-infection.

4) All samples and used articles should be treated as potential sources of infection.

5) It is recommended to use fresh samples, and never freeze-thaw samples repeatedly.

6) Compared with adults, children are more likely to spread the virus in a wider range and last longer. Therefore, the sensitivity of children's detection may be higher than that of adults.

7) For the detection reagent of influenza A virus or each subtype, when the antibody used is monoclonal, the slight change of epitope caused by small mutation of nucleotide sequence may lead to false negative result or decrease of analytical sensitivity of reagent.

8) When adding samples, add them vertically one by one to each sample hole to avoid insufficient sample volume due to bubbles, which will affect the interpretation of the product.