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Molecular test for the detection and identification of 76 serotypes of S. pneumoniae

The S.pneumoStrip kit is a professional molecular test for the detection and identification of 76 serotypes of S. pneumoniae in DNA samples extracted from blood culture, pleural fluid or cerebrospinal fluid, or bacterial cultures.

The S.pneumoStrip kit is the only commercial molecular test that allows rapid, simple and reliable detection of 76 serotypes of Streptococcus pneumoniae (S.pneumoniae), including the 23 serotypes present in current pneumococcal vaccines (7-valent, 10-valent, 13-valent and 23-valent). Thanks to its technology optimised for the use of direct sampling, without the need for prior positive culture, it offers an accurate and accessible diagnosis, facilitating decision making in laboratories, hospitals and research centres.

Infections caused by S. pneumoniae are a major public health problem worldwide, with high morbidity and mortality in both industrialised and resource-poor countries. This pathogen is responsible for diseases ranging from otitis media and acute sinusitis to severe invasive infections such as pneumonia, meningitis and septicaemia, causing 1.6 million deaths annually, 800,000 of them in children under 5 years of age. The World Health Organisation (WHO) recommends epidemiological surveillance to assess the impact of vaccination strategies and to monitor the circulation of different pneumococcal serotypes. Traditionally, this serotyping has been performed using the Quellung technique, which is recognised as the reference method, but requires time, specific reagents and highly trained personnel.

The S.pneumoStrip kit revolutionises this process by providing fast and accurate results, without the need for laborious techniques or highly specialised equipment, making it an essential tool for the diagnosis and investigation of pneumococcal disease.

Only commercial molecular test

Perfect correlation with Gold Standard

76 serotypes in one test

Possibility to automate the hybridization process

No need of previous culture

Our products for the detection and differentiation of 76 serotypes of S.pneumoniae

Product
Technique
Sample
Promotional Sheet
CE Decl.
Reference No.
S.pneumoStrip
Hybridization on Strip
DNA from bacterial cultures, blood culture, pleural fluid, cerebrospinal fluid
3.165.016.53.000
Test for the detection and differentiation of 76 serotypes of S.pneumoniae

The only commercial molecular test with IVD-CE marking for the genetic serotyping of S. pneumoniae. It allows the detection and differentiation of 76 serotypes in a single test, including those present in vaccines, which allows monitoring the efficacy and effect of the vaccines.

It has a 99.9% correlation with Gold Standard (Quellung), with the added advantage of being faster, simpler and cheaper. In addition, it allows the use of samples without a previous culture, so that results can be obtained even from those strains that are not viable in culture.

As it can detects and differentiates all serotypes in a single test, it is very useful when co-infections are present. This is very useful for carrier studies as well as for other epidemiological studies. The detection of 3 internal controls allows the unequivocal identification of S. pneumoniae even in the presence of other pneumococci.

The technique can be automated and the result can be read with the help of a scanner, allowing the results to be recorded and optimizing the execution of the test.

Publications

N1
Title
Link
Language
C1
Utility of a Reverse-Hybridization Strip Assay for Streptococcus pneumoniae serotyping
English
C2
Streptococcus pneumoniae detection based in the cpsA and cpsC genes will miss serotypes 25A, 25F and 38
English
C3
Utility of PneumoStrip, a Reverse-Hybridization Nylon Strip Assay prototype, for Streptococcus pneumoniae serotyping
English
C4
Direct-serotyping-of-streptococcus-pneumoniae-in-blood-culture-samples-by-using-a-PCR-reverse-hybridization-test
English
C5
Direct-identification-of-Streptococcus-pneumoniae-serotypes-in-cultures-negative-samples-by-a-PCR-reverse-hybridization-technique
English
C6
Impacto de la vacunada conjugada 13-valente en la enfermedad neumocócica invasiva en Navarra
Spanish
C7
Direct identification of Streptococcus pneumoniae serotypes in culture negative paediatric clinical samples by a PCR reverse-hybridization strip-based commercial assay
English
A1
A reverse-hybridization test for the identification of 76 pneumococcal serotypes, 42 individually and 34 in pairs
English
A2
Direct identification of pneumococal serotypes in blood cultures by a PCR-reverse-hybridization technique
English
A3
Comparison of Four Methods for Streptococcus pneumoniae capsular typing
English
A4
Carriage and distribution of serotypes Streptococcus pneumoniae in healthy vaccinated children for the year 2021 in Bulgaria
English
A5
High frequency of Streptococcus pneumoniaeserotype 3 in negative pleural fluid culturesfrom paediatric samples obtained in the Madridregion from 2018 to 2022, detected by directidentification using PCR-reverse-hybridizationstrip-based assay
English
A6
Impact of the progressive uptake of pneumococcal conjugate vaccines on the epidemiology and antimicrobial resistance of invasive pneumococcal disease in Gipuzkoa, northern Spain, 1998-2022
English
A7
Predominant Pneumococcal Serotypes in Isolates Causing Invasive Disease in a Spanish Region: An Examination of Their Association with Clinical Factors, Antimicrobial Resistance, and Vaccination Coverage
English
A8
Impact of the National Vaccination Strategy on the Prevalence of Streptococcus pneumoniae and Its Serotypes Among Clinically Healthy Children Under Six Years of Age During and After the COVID-19 Pandemic
English
A9
Comparative Analysis of Pneumococcal Serotypes for 10 Years (2014-2024) in the Comunidad Valenciana Region, Spain, and How They Are Correlated with PCV13, PCV20, and PCV21
English
A10
Respiratory infections in the post-COVID-19 era: impact, prevalence, and clinical characteristics of bacterial and viral co-infections
English
A11
Pneumococcal Meningitis in a Region of Northern Spain, 1993-2023: Incidence Trends, Clinical Features, Recurrences, and Antibiotic Resistance
English
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    Frequently Asked Questions

    The kit was initially designed to be used on culture samples, so the best results are obtained using them. Nevertheless,  it has been shown in different studies to be useful also with non-cultured samples. In those cases, the sensitivity of the test may be affected by having less DNA in the starting sample, which would be reflected in the lack of signal in the internal controls of the test. If so, sensitivity can be increased by performing individual PCRs with each set of primers, instead of performing a single PCR with all primers.

    No. The detection of 3 internal controls allows unequivocal identification of S. pneumoniae, even in the presence of other pneumococci.