5 In 1 Multiple Respiratory Multipathogen Antigen Test Kit

Warning: This product is not suitable for the US market !

Bioteke Corporation 5 In 1 Respiratory Multiple Pathogen Antigen Rapid Antigen Test Kit

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Suitable for personal daily self-test/pharmacies/clinics/laboratories, etc.

[Test Principle]

The  kit is  immunochromatographic and uses double-antibodly sandwich method to detect SARS-CoV-2(COVID 19)/Influenza A virus/ Influenza B virus / Respiratory syncytial virus / Adenovirus antigen.During detection,the treated specimens are loaded into the sample wells of the test card.When the concentration of SARS-CoV-2/Influenza A virus,Influenza  B  virus/Respiratory syneytial virus/Adenovirus antigen in specimen is higher than the minimum detection limit, the viral antigen will  form complexes with labeled antibodies first.Under chromatography, the complexes move forward along the nitrocellulose membrane till captured by pre-coated monoclonal antibody of SARS-CoV-2/Influenza A virus/Influenza B virus/Respiratory syneytial virus/Adenovirus  in detection zone on nitrocellulose film to form a red or  blue reaction line on thedetection zone,at  this  point the result  is  positive;Canversely,if there is no viral antigen or the concentration of antigen in specimen is below the minimum detection limit,no red/blue reaction  line appears in the detection zone,at this point the result is negative.Regardless of whether the sample contains viral antigens or not,a dark blue/purple  reaction line will appearin the quality control zone (C),the dark  blue/purple  reaction line that appears in the quality control zone (C) is the criterlon for determining  if the  chromatography   process  is  normal.

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[Materials Provided]

Test card,Sample extraction tube,Tube cap,Anterior nasal swab,Waste bag,User Manual

Packing specification:

1 test/box,600 tests/carton	20 tests/box,800 tests/carton
box size:16.2×6.6×1.5cm	box size:24×16.6×6.5cm
carton size:66×40×42cm	carton size:68×49×35cm

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[R&D Test Result Analysis]

Statistic	Value
Sensitivity	96.97%
Specificity	100.00%
Total coincidence rate	98.05%

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[Test Procedure]

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[Results Interpretation]

Note: Please read the results within 15-20 minutes after the test. Results read after 30 minutes will be invalid.

[Positive]

SARS-CoV-2 positive:Two  coloured lines appear  in  the  COVID-19/Flu A/Flu B test  window.A  dark blue/purple Iine is in the(C) section and a red line is in the (COVID-19) section. 

Influenza A (Flu A) positive:Two coloured lines appear in the COVID-19/Flu A/Flu B test window.A dark blue/purple Iine is in the(C) section and a blue line is in the (Flu A) section.

Influenza B (Flu B) positive:Two coloured lines appear in the COVID-19/Flu A/Flu B test window.A dark blue/purple Iine is in the(C) section and a blue line is in the (Flu B) section.

Adenovirus (ADV) positve:Two coloured lines appear in the ADV/RSV test window.A dark blue/purple Iine is in the(C) section and a red line is in the (ADV) section.

Syncytial virus (RSV)  positive:Two coloured lines appear in the ADV/RSV test window.A dark blue/purple Iine is in the(C) section and a blue line is in the (RSV) section.

Multiple positive:Two coloured (C) lines appear in two separate window.If the other line appears,the corresponding pathogen is positive.

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[Negative]

In the SARS-CoV-2/Influenza A virus/Influenza B virus/Respiratory syncytialvirus/Adenovirus detection window,two dark blue/purple lines appear in the (C) section and no line appears in the detection area (COVID-19/Flu A/Fu B/ADV/RSV).It indicates that SARS-CoV-2,Influenza A virus,Influenza B virus,Respiratorysyncytial virus or Adenovirus was not detected in the sample.However,a negative result does not exclude the absence of SARS-CoV-2,influenza A virus,influenza B virus,respiratory syncytial virus,Adenovirus infection and should not be used as the sole basis for treatment or patient management decisions.

Negative results should be considered in the context of the individuals recent exposure history,medical history and the presence of clinical signs and symptoms consistent with SARS-CoV-2,influenza A virus,Influenza B virus,Respiratory syncytial virus and adenovirus,and confirmed by nucleic acid testing as necessary for patient management.

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[Invalid]

If any of the control (C) lines do not appear,the test is considered invalid.

An invalid test result means that your test has encountered an error and the results cannot be interpreted.You will need to retest using a new test card.

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[Performance Characteristics]

For analysis of specificity and other experimental data, please refer to the attachment/user manual.

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