INTENDED USE

The Para Influenza Virus Antigen Rapid Test Kit is a lateral flow chromatographic immunoassay for the qualitative detection of Para Influenza Virus in human swab (oropharyngeal swab, nasopharyngeal swabs and Anterior nasal swab). It is suitable for the auxiliary diagnosis of Para Influenza virus infection.

INTRODUCTION

Human parainfluenza viruses (HPIVs) commonly cause upper and lower respiratory illnesses. The symptoms of HPIVs are not severe enough to cause concern in healthy adults. However, they can be life-threatening in an infant, the elderly, or anyone with a compromised or weakened immune system.
There are four types of parainfluenza viruses which cause respiratory infections. The exact type of infection, the symptoms, and the location of the infection depends on the type of virus:
HPIV-1: the leading cause of croup in children
HPIV-2: also causes croup in children, but it is detected with less frequency than HPIV-1
HPIV-3: mainly associated with bronchiolitis and pneumonia
HPIV-4 (includes subtypes 4A and 4B): not as well known, but may cause mild to severe respiratory tract illnesses
HPIVs are spread from person to person by direct contact or exposure to contaminated secretions from the nose or throat. Most children are infected with HPIV-3 by the age of two years and with HPIV-1 and HPIV-2 by the age of five years. HPIV-3 infections are a major cause of pneumonia and bronchiolitis in infected infants under 6 months old.

PRINCIPLE

The Para Influenza Virus Antigen Rapid Test Kit is a lateral flow chromatographic immunoassay. The test cassette consists of: 1) a burgundy colored conjugate pad containing recombinant antigen conjugated with colloid gold (monoclonal mouse anti Para Influenza Virus antibody conjugates) and rabbit IgG-gold conjugates, 2) a nitrocellulose membrane strip containing test band (T bands) and a control band (C band). The T band is pre-coated with monoclonal mouse anti-Para Influenza Virus antibody for the detection of Para Influenza Virus antigen, and the C band is pre-coated with goat anti rabbit IgG. When an adequate volume of test specimen is dispensed into the sample well of the test cassette, the specimen migrates by capillary action across the cassette. Para Influenza Virus if present in the specimen will bind to the monoclonal mouse anti-Para Influenza Virus antibody conjugates. The immunocomplex is then captured on the membrane by the pre-coated mouse anti-Para Influenza Virus antibody, forming a burgundy colored T band, indicating a Para Influenza Virus antigen positive test result. Absence of test band (T) suggests a negative result. The test contains an internal control (C band) which should exhibit a burgundy colored band of the immunocomplex of goat anti rabbit IgG/rabbit IgG-gold conjugate regardless of the color development on any of the test bands. Otherwise, the test result is invalid, and the specimen must be retested with another device.