Combo Test COVID-19 & INFLUENZA A+B Ag 25T AMP DIAGNOSTICS
EOF product registration number: 2830000644656
It has CE quality certification
Rapid Test to limit the spread of COVID – 19 and INFLUENZA A+B
Extreme sensitivity & specialty …
Rapid immunochromatographic test for qualitative and differential detection of nucleocapsid protein antigen of SARS-CoV-2, Influenza A (including H1N1) and/or Influenza B in human nasopharyngeal swab samples as an aid in rapid diagnosis of Coronavirus (Covid-19), Influenza A and/or B infection
- 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
The test is performed by applying the extracted sample to the sample wells (S) of the cassette and observing the formation of colored lines.
Nucleocapsid protein antigen to SARS-CoV-2 are detected by utilizing highly sensitive monoclonal antibodies. The sample migrates by capillary effect along the membrane. If present in the sample, SARS-CoV-2 antigen react with monoclonal antibody conjugated with colloidal-gold particles and are captured by secondary monoclonal antibodies immobilized in the Test (T) region. A colored line will form in the Test (T) region. The presence of this colored line indicates a positive result, while its absence indicates a negative result.
Influenza type A and type B nucleoprotein antigens are detected by utilizing highly sensitive monoclonal antibodies. The sample migrates by capillary effect along the membrane. If present in the sample, Influenza A and/or B react with monoclonal antibody coated
with colloidal-gold particles and are captured by secondary monoclonal antibodies immobilized in the test (A/B) region. A colored line will form at the Test (A/B) region of the membrane. The presence of this colored line indicates a positive result, while its absence
indicates a negative result.
As a procedure control a coloured line has to appear in the Control (C) region of both tests confirming that sufficient sample has been absorbed.
Detection limit (LOD):
The minimum detectable concentration of SARS-CoV-2 Ag is 1.15 x 102 TCID50/mL.
Sensitivity and specificity:
AMP Rapid Test SARS-CoV-2 Ag has been evaluated with clinical patient samples using a commercial molecular assay (RT PCR) as a reference method. Sensitivity, specificity and overall relative accuracy have been found to be as following:
Test sensitivity: 97.3% (95% CI: 90.0% – 99.8%)
Test specificity: 100.0% (95% CI: 96.6% – 100%)
Relative accuracy: 98.8% (95% CI: 91.8% – 99.9%)
AMP Rapid Test Influenza A+B:
The minimum detection limit is 1.5 x 104 TCID50/test for Influenza A virus antigen and 1.5 x 105 TCID50/test for Influenza B virus antigen.
Sensitivity and specificity:
AMP Rapid Test Influenza A+B has been tested versus cell culture. Sensitivity, specificity and correlation among the two methods has been found to be as following:
Α ————————— – Β
Sensitivity:——————————92.6% ———- ——————— 90.0%
Specificity:—————————– –96.4% ——————————- 95.8%
Relative accuracy:———————95.5% ——————————- 94.4%
The following substances did not show any interference:
Human blood (EDTA), anti-viral drugs, antibiotics/anti-bacterial drugs, nasal sprays or nose drops, nasal corticosteroids.
Available in a package of 25 tests.