Combo Test COVID-19 & INFLUENZA A+B Ag 25T RIGHTSIGN

EOF product registration number: 2830000642119

It has CE quality certification

Rapid Test to limit the spread of COVID – 19 and INFLUENZA A+B

Extreme sensitivity & specialty …
Nasopharyngeal swab

A rapid test for the qualitative detection of SARS-CoV-2, Flu A&B Antigen in
Nasopharyngeal swab. For professional in vitro diagnostic use only.

PROVIDED MATERIALS

• 25 Individual aluminum packages each containing a Test cassette and a desiccant
• 1 extraction buffer
• 25 Sterile swabs
• 25 sample collection tubes with the corresponding dropper tips
• 1 tube holder

PRINCIPLE

The SARS-CoV-2 Antigen Rapid Test Cassette (Nasopharyngeal Swab) is a qualitative, lateral flow immunoassay for the detection of the N protein of SARS-CoV-2 in Nasopharyngeal swab. In this test, antibody specific to the N protein of SARS-CoV-2 is separately coated on the test line regions of the test cassette. During testing, the extracted specimen reacts with the antibody to N protein of SARS-CoV-2 that are coated onto particles. The mixture migrates up the membrane to react with the antibody to N protein of SARS-CoV-2 on the membrane and generate one colored line in the test regions. The presence of this colored line of the test regions indicates a positive result. To serve as a procedural control, a colored line will always appear in the control region if the test has performed properly.
The FLU A&B Antigen Rapid Test Cassette（Nasopharyngeal Swab） is a qualitative, lateral flow immunoassay for the detection of Influenza A and Influenza B nucleoproteins in Nasopharyngeal Swab. In this test, antibody specific to the Influenza A and Influenza B nucleoproteins is separately coated on the test line regions of the test cassette. During testing, the extracted specimen reacts with the antibody to Influenza A and/or Influenza B that are coated onto particles. The mixture migrates up the membrane to react with the antibody to Influenza A and/or Influenza B on the membrane and generate one or two colored lines in the test regions. The presence of this colored line in either or both of the test regions indicates a positive result. To serve as procedural control, a colored line will always appear in the control region if the test has performed properly.

TEST PROCEDURE

PERFORMANCE CHARACTERISTICS

Sensitivity, Specificity and Accuracy
The SARS-CoV-2+Flu A&B Antigen Combo Rapid Test Cassette（Nasopharyngeal Swab）has been evaluated with specimens obtained from the patients. RT-PCR is used as the reference method for the SARS-CoV-2+Flu A&B Antigen Combo Rapid Test Cassette (Nasopharyngeal Swab). Specimens were considered positive if PCR indicated a positive result.

Available in a package of 25 tests.