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.