Streptococcus Pneumoniae Rapid Test

Description

Intended Use

Streptococcus Pneumoniae Rapid Test (Urine) is an in vitro diagnostic rapid immunochromatographic assay for the qualitative detection of Streptococcus pneumoniae antigen in human urine specimens. Streptococcus Pneumoniae Rapid Test (Urine) may be used as an aid in the diagnosis of S. pneumoniae infections. A reactive result should be confirmed by supplemental testing such as culture and molecular methods.

Introduction

S. pneumoniae, is a Gram-positive, alpha-hemolytic or beta-hemolytic, facultative anaerobic member of the genus Streptococcus1. S. pneumoniae resides asymptomatically in healthy carriers typically colonizing the respiratory tract, sinuses, and nasal cavity. However, in susceptible individuals with weaker immune systems, such as the elderly and young children, the bacterium may become pathogenic and spread to other locations to cause disease. It spreads by direct person-to-person contact via respiratory droplets and by autoinoculation in persons carrying the bacteria in their upper respiratory tracts.2

S. pneumoniae is the main cause of community acquired pneumonia and meningitis in children and the elderly3, and of septicemia in those infected with HIV. The organism also causes many types of pneumococcal infections other than pneumonia. These invasive pneumococcal diseases include bronchitis, rhinitis, acute sinusitis, otitis media, conjunctivitis, meningitis, bacteremia, sepsis, osteomyelitis, septic arthritis, endocarditis, peritonitis, pericarditis, cellulitis, and brain abscess4.

The diagnosis of pneuococcal pneumonia is based on the presence of clinical signs of pneumonia, lung infiltrates and microbiological findings (microscopy and culture of sputum or blood, and presence of urinary pneumococcal antigen)5. In the clinical situation it is often difficult to make a definite diagnosis, which can only be fulfilled when the patient has symptoms of pneumonia and a positive culture from blood or pleura. This is only possible in 10-20% of the cases, and a range of patients are regarded as probable cases.

A rapid diagnosis of pneumococcal infection can be performed by urinary antigen test, as pneumococcal polysaccharide antigen is excreted in the urine early in infection5. Urinary antigen detection provides a simple, rapid and noninvasive method for the diagnosis of pneumococcal pneumonia, thus providing earlier and effective antibiotic therapy.

Materials

• Test devices
• Droppers
• Package insert

Warnings and Precautions

• For professional in vitro diagnostic use only.
• Read these instructions carefully before performing the test.
• Do not use the test beyond the expiration date.
• Do not use the test if the packaging is damaged.
• Do not reuse tests.
• Apply standard biosafety precautions when handling and disposing of potentially infectious materials.
• Handle all specimens as potentially infectious.
• Wear protective clothing such as gloves, laboratory coats, and eye protection when specimens are being assayed.
• The test device and accessory should be disposed in a proper biohazard waste container after testing.
• Do not eat, drink or smoke in the area where the specimens and kits are handled.
• Avoid splashes and clean up spills immediately with appropriate disinfectant.
• Avoid cross-contamination of specimens by using a new specimen collection container for each specimen obtained.
• Humidity and temperature can adversely affect results.
• Used testing materials should be discarded in accordance with local regulations.

Test Procedure

Bring the test device, specimen to room temperature (15~30°C) prior to testing.

1. Remove the test device from its sealed pouch and use it as soon as possible. For best results, the assay should be performed within one hour.

2. Place the test device on a clean, level surface. Label with specimen ID.

Hold the dropper vertically and transfer 3 drops of urine (approximately 120 µL) to the sample well (S) of the test device, and start the timer.

Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result area.

3. Read results at 10 minutes.