CDIA™ Streptococcus Pneumoniae Rapid Test Kit - Creative Diagnostics

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Infectious Disease Tests | S. pneumoniae |

CDIATM Streptococcus pneumoniae Rapid Test Kit (DTSJL-1622)

Intended Use

Streptococcus pneumoniae Rapid Test Kit is a qualitative rapid assay which is intended to be used for the detection of Streptococcus pneumoniae antigen in urine without any dilution and as an aid in the diagnosis of pneumonia, meningitis and otitis media. For laboratory use only.
  • Urine
  • Card
  • 79% (26/33)
  • 84% (21/25)

Product Introduction

INTRODUCTION

Streptococcus pneumoniae (S. pneumoniae) is a gram-positive bacterium first isolated from the saliva of a patient with rabies by Pasteur in 1881. The chemical structure and antigenicity of the pneumococcal capsular polysaccharide and its association with virulence and its role in human disease were explained over the period of 1915 to 1945. The bacteria are lancet-shaped anaerobic organisms spreading by direct person-to-person contact via respiratory droplets and causing serious disease in humans: The 10 most common serotypes are estimated to account for about 62% of invasive disease worldwide. S. Pneumoniae colonizes upper respiratory tract tissues causing severe pneumonia and mild/acute earache/otitis. Pneumococci cause 13% to 19% of all cases of bacterial meningitis in the United States. One-fourth of patients with pneumococcal meningitis also have pneumonia. Clinical symptoms are generally similar to those of other forms of purulent bacterial meningitis and include headache, lethargy, vomiting, irritability, fever, nuchal rigidity, cranial signs, seizures and coma. The case-fatality of pneumococcal meningitis is about 30% but can be as high as 80% among the elderly. Bacterial pneumonia accounts for 12-16% of invasive pneumococcal disease among children aged 2 years and younger whereas S. Pneumoniae has become the leading cause of bacterial meningitis among children younger than 5 years of age in the United States. Antibiotic treatment is efficient even if more penicillin-resistant strains have been identified. Several vaccines are available with variable efficiency depending on patient age or whether patients are developing some chronic illness or immunodeficiency. Nevertheless, vaccines have been demonstrated to provide protection against pneumococcal pneumonia.

PRINCIPLE

Streptococcus pneumoniae Rapid Test Kit is a qualitative rapid assay for the detection of Streptococcus pneumoniae antigen in urine without any dilution. The method employs a unique combination of monoclonal antibody-dye conjugate and monoclonal solid phase antibodies directed to different epitopes to selectively identify Streptococcus pneumoniae with a high degree of sensitivity. As the test sample is added, the labelled antibody-dye conjugate binds to the S. pneumoniae antigen forming an antibody-antigen complex. This complex binds to immobilized S. pneumoniae antibody in the test line region (T) producing a rose-pink-coloured line. In absence of S. pneumoniae in the sample, there will be no line present in the test line region (T). The reaction mixture continues flowing along the membrane. Unbound conjugate binds to reagents in the control line region (C) producing a rose-pink-coloured line, indicating correct functioning of the test reagents and correct procedural technique.

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