WHAT DOES THE KIT TEST?

The fluorecare® SARS-CoV-2 & Influenza A/B & RSV Antigen Combined Test Kit is applicable to the simultaneous qualitative detection and differentiation of novel Coronavirus (SARS-CoV-2 Antigen), Influenza A virus, Influenza B virus Antigen and/or RSV Antigen in population Nasal swabs samples in vitro.

It can be used as an aid to diagnose coronavirus infection disease (COVID-19), caused by SARS-CoV-2, in symptomatic patients within 7 days of onset. It can also be used to aid in the diagnosis of diseases caused by Influenza A/B or RSV.

For in vitro diagnostic use only. For self-testing use.
Specifications

1 Test/box，2 Tests/box ,5 Tests/box

MAKE SURE YOUR TEST KIT CONTAINS

1. Test Card

2. Sample treatment solution

3. Sterile nasal swabs

4. Sample treatment tube

User age requirement

This kit is suitable for people over 2 years old.

People under the age of 2-14 cannot operate by themselves. This kit should be used by adults or parents (18-60 years old) for sample collection and testing.

People aged 14-17 can use this kit to collect samples and test samples under the supervision of adults or parents (18-60 years old). Supervisors should ensure that users have a detailed understanding of the requirements of the instructions and watch whether the user's operation is correct.

For people over 75 years old, it is recommended that family members or guardians (18-60 years old) use this kit to collect samples and test samples.

BACKGROUD

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.

Influenza (flu) is a contagious respiratory illness caused by influenza viruses. Influenza viruses can cause mild to severe illness. Serious outcomes of the flu can result in hospitalization or death. Some people, such as older people, young children, and people with certain underlying health conditions, are at higher risk for serious flu complications. There are two main types of influenza viruses: types A and B. Both type A and B influenza viruses regularly spread in people, and are responsible for seasonal flu each year. Influenza viruses can be spread to others before and after a person shows signs and symptoms of being sick.

Respiratory syncytial virus (RSV) belongs to the genus Pneumovirus of the family Paramyxoviridae. It can be infected by coughing and air droplets, mainly causing lower respiratory tract infections such as bronchiolitis and pneumonia in infants under 6 months, and upper respiratory tract infections such as rhinitis and cold in older children and adults, and bronchitis or pneumonia in the elderly.

PRINCIPLE

The SARS-CoV-2 & Influenza A/B & RSV Antigen test is a qualitatively test to detect SARS-CoV-2 Antigen / Influenza A/B Antigen/RSV Antigen in Nasal swabs samples by the colloidal gold method. After sample added, the SARS-CoV-2 Antigen (or Influenza A/B & RSV) in the sample to be tested is combined with the SARS-CoV-2 (or Influenza A/B & RSV) antibody labelled with colloidal gold on the Conjugate pad to form the SARS-CoV-2 Antigen (or Influenza A/B & RSV) antibody-colloidal gold complex. Due to chromatography, the SARS-CoV-2 Antigen (or Influenza A/B & RSV)-antibody-colloidal gold complex diffuses along the nitrocellulose’s membrane. Within the detection line area, the SARS-CoV-2 Antigen (or Influenza A/B & RSV)-antibody complex binds to the antibody enclosed within the detection line area, showing a purple-red band. Colloidal gold labelled SARS-CoV-2 (or Influenza A/B & RSV) antibody diffuses to the quality control line (C) region and is captured by Goat anti-mouse IgG to form red bands. When the reaction is over, the results can be interpreted by visual observation.

LIMITATION OF METHODOLOGY

1. This kit is a qualitative test and is only used for in vitro auxiliary diagnosis.

2.  Negative test results may occur if the level of antigen in a sample is below the detection limit of the test, or from improper sample collection, and the negative results are not intended to exclude other non COVID-19 virus, Influenza virus or RSV virus infections.

    3.  Unreasonable sampling, transportation, handling, and low virus content in samples may lead to false negatives.

    4. This reagent is a qualitative assay. As it is with any diagnostic procedure, a confirmed virus infection diagnosis         should only be made by a physician after evaluating all clinical and laboratory findings.

    5.  Reading the test results earlier than 15 minutes or later than 20 minutes may give incorrect results.

6. A negative test result for COVID-19, Influenza A/B or RSV Antigen does not rule out COVID-19, Influenza A/B or RSV infection and does not exempt you from the applicable rules for spread control (e.g. contact restrictions and protective measures).

13.  The final result should be read in 15 minutes. Please do not read the result after 20 minutes.

    14.  Various components of different batch of reagents cannot be used interchangeably in order to avoid wrong results
 
STORAGE CONDITION AND EXPIRY DATE

1.Test kit store at 2-30℃ in dry place and protect from light. Test kit is valid for 18 months. 2.The Test Card must remain in the sealed pouch until use. Once the test card pouch is opened, the test should be performed within 1 hour.