Reagents and material supplied:

Test time: 10 min

Performance characteristics:
The NADAL® Streptococcus Pneumoniae Test shows no cross-reactivity with the following microorganisms: Strep A, B, C, D, E, F, G & H, Staphylococcus Aureus, Bacillus subtitilis. Positive result for cross-reactivity with Streptococcus Pneumoniae capsular types (8) was observed.

 

The diagnostic specificity and sensitivity data for NADAL® Streptococcus Pneumoniae Test were confirmed by comparison with another rapid immunoassay – BinaxNOW®

 

Streptococcus pneumonia.

 

Diagnostic sensitivity: 79%

 

Diagnostic specificity: 84%

 

Overall agreement: 81%

 

Analytical sensitivity of NADAL® Streptococcus Pneumoniae Test was determined by testing diluted S. pneumonia cultures and further comparison of the results with the those obtained by means of BinaxNOW® Streptococcus pneumonia. Both tests show the same sensitivity.

Intra-assay reproducibility: 100%

 

Test principles:
The NADAL® Streptococcus Pneumoniae Test is a qualitative lateral flow immunoassay for the detection of S. pneumoniae antigens in urine (without sample dilution).

 

The NADAL® Streptococcus Pneumoniae Test owes its sensitivity to two monoclonal antibodies targeted at different epitopes. First, the anti-S. pneumoniae antibodies eventually present in the sample (in the case of positive result) react with antibodies bound to coloured particles pre-dried on the internal test strip, further the samples moves along the membrane by capillary action and specific antibodies present on test line react with the mixture conjugate and generate a rose-pink-colored line in the test (T) region of the cassette. A rose-pink line should always appear in the control line region (C)and serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.