Why choose our test?

The GenomEra^® S. pneumoniae Assay Kit enables rapid, reliable, and specific molecular detection of Streptococcus pneumoniae from positive blood cultures in less than one hour. Fast diagnosis enables timely initiation of treatment measures and improved patient outcomes.

 S. pneumoniae—pneumococcus—is the leading cause of pneumonia and can also cause otitis media, sinusitis, bacteremia, meningitis, and other tissue infections¹. Pneumococcal infections are most commonly encountered in children, immunocompromised individuals, and the elderly². S. pneumoniae is associated with high morbidity in children, especially when related with an infection of the respiratory tract and ear infections. Infection of the middle ear (otitis media) is a very common illness in infants and usually occurs during epidemics of simple colds or sore throats, during which infectious microbes accumulate in the middle ear fluid.

S. pneumoniae can also cause conjunctivitis, osteomyelitis, and community-acquired pneumonia. The most severe complications of a pneumococcal infection are invasive pneumococcal diseases, including sepsis and meningitis. Although these forms of pneumococcal infections are relatively infrequent, they are associated with high morbidity and mortality in the neonatal period³. An infection caused by S. pneumoniae in neonates younger than three weeks of age is most often obtained from the mother at birth⁴.

Diagnosis of pneumococcal bacteremia typically relies on performing a blood culture, followed by Gram staining, subculturing on sheep blood agar, and biochemical tests such as the bile solubility and the optochin susceptibility tests⁵. By conventional methods, the detection of pneumococcus may take up to three days⁶. S. pneumoniae also has a strong tendency of autolysis, significantly delaying or hampering diagnosis⁷. Additionally, issues remain in the differentiation between S. pneumoniae and the closely related viridans streptococci by MALDI-TOF-based methods^6,8.The GenomEra S. pneumoniae Assay Kit based on DNA amplification ensures detection of S. pneumoniae rapidly and reliably.

Key facts

• Sensitive detection of Streptococcus pneumoniae directly from blood cultures
• Rapid and easy-to-use molecular diagnostics on the automated GenomEra® CDX PCR platform
• Significantly improved turnaround time in comparison to conventional microbiology and biochemical methods—results in just 50 minutes

Assay principle

The GenomEra S. pneumoniae Assay Kit is based on the amplification of S. pneumoniae DNA by end-point polymerase chain reaction (PCR) from cultured primary blood samples suspected positive for S. pneumoniae. Pre-culturing times typically range from 10 hours to several days.

The GenomEra S. pneumoniae Assay Kit has a very simple sample preparation process and yields reliable results in just 50 minutes on the GenomEra® CDX instrument. Pre-loaded and sealed test chips allow for easy testing and safe waste disposal. The automated GenomEra® platform makes molecular diagnostics rapid and effortless.

The GenomEra S. pneumoniae Assay Kit is intended for use in clinical laboratory settings as an aid in the diagnosis of pneumococcal bacteremia. Concomitant testing is necessary only if further typing or antibiotic resistance information is required.

Clinical performance

The clinical performance of the GenomEra S. pneumoniae Assay Kit was assessed in a study consisting of 226 positive blood culture samples (Table 1). Conventional microbiological test methods, such as Gram staining, latex agglutination and optochin test for identification, and E-test, standardized single disk tests and VITEK 2 AST-ST01 for antibiotic susceptibility, were used as reference methods. VITEK 2 GP and/or MALDI Biotyper were used to identify other bacterial species.

Table 1. The GenomEra S. pneumoniae Assay Kit had outstanding sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) on clinical samples.

Sample size (n)	Sensitivity, % (n)	Specificity, % (n)	PPV, %	NPV, %
226	100 (82/82)	100 (144/144)	100	100

The detection sensitivity and specificity of the GenomEra S. pneumoniae Assay Kit for direct analysis of S. pneumoniaein signal-positive blood culture has also been shown to be perfect (100%)⁹.

Ordering information

To place an order, please contact your local distributor.

Product name	Product code
GenomEra S. pneumoniae Assay Kit
20 tests	CDX-70-01-20
40 tests	CDX-70-01-40
GenomEra CDX System	CDX-10-020

The GenomEra S. pneumoniae Assay Kit has received the European CE marking for In Vitro Diagnostic (IVD) medical devices according to the requirements of EU Directive 98/79/EC (IVDD) and is available in European markets. In other markets, please contact your local distributor for availability. The product is manufactured by Uniogen, Finland.

References

1. Mitchell 2003. The pathogenesis of streptococcal infections: from tooth decay to meningitis. Nat Rev Microbiol 2003;1:219–30.
2. Hausdorff WP, Feikin DR, Klugman KP. Epidemiological differences among pneumococcal serotypes. Lancet Infect Dis 2005;5:83–93.
3. Factsheet about pneumococcal disease; , 8/7/2022.
4. Ostapchuk M, Roberts DM, Haddy R. Community-acquired pneumonia in infants and children. American family physician 2004; 70(5); 899-908.
5. Todar 2002. Streptococcus pneumoniae: Pneumococcal pneumonia. Todar’s Online Textbook of Bacteriology. Accessed 4.9.2013.
6. Selva L, Esteva C, Gené A, de Sevilla MF, Hernandez-Bou S, Muñoz-Almagro C. Direct detection of Streptococcus pneumoniae in positive blood cultures by real-time polymerase chain reaction. Diagn Microbiol Infect Dis 2010;66:204–6
7. Werno AM, Murdoch DR. Medical microbiology: laboratory diagnosis of invasive pneumococcal disease. Infect Dis 2008;46:926–32.
8. Vernet G, Saha S, Satzke C, Burgess DH, Alderson M, Maisonneuve JF, Beall BW, Steinhoff MC, Klugman KP. Laboratory-based diagnosis of pneumococcal pneumonia: state of the art and unmet needs. Clin Microbiol Infect 2011;17(Suppl 3):1–13
9. Hirvonen JJ., Seiskari T, Harju I, Rantakokko-Jalava K, Vuento R., Aittoniemi J. Use of an automated PCR assay, the GenomEra S. pneumoniae, for rapid detection of Streptococcus pneumoniae in blood cultures. Infectious Diseases 2015; 47(11); 796-800.