Anti-B. pertussis Toxin Alegria Monotest

Bordetella pertussis, which causes whooping cough, is a small, Gram-negative bacterium in the coccobacillus family. It is transmitted by airborne droplets and is highly contagious.

Whooping cough is one of the most dangerous infectious diseases for infants; it is potentially fatal. In adolescents and adults the infection usually has milder symptoms and is often not recognized as whooping cough. This may cause individuals to transmit the disease to vulnerable younger children.

Laboratory diagnosis in infants can be accomplished through direct detection after bacterial culture of by PCR. In adolescents and adults -- who usually only consult a doctor if symptoms persist for a long time -- indirect serological methods are more suitable. These include ELISA tests to detect the pertussis toxin produced by these bacteria, which is the most important pathogenic factor.

The Anti-B. pertussis Toxin ELISA tests from ORGENTEC Diagnostika (ORG 916A, ORG 916G) use highly purified, native pertussis toxin as antigen for the detection of IgA or IgG antibodies. These pure pertussis toxin ELISA tests allow for the quantification of the antibodies. Both ORGENTEC assays are calibrated against international WHO standards.

According to recommendations of the European Consensus for Reference Laboratories for Bordetella pertussis, quantitative results like those obtained with the ORGENTEC Anti-B. pertussis Toxin IgA and IgG tests can confirm recent exposure to this pathogen. The guidelines propose a two-step cut-off, which is applicable if the patient has not been vaccinated within the last 12 months.

Anti-PT IgG < 50 IU/ml and Anti-PT IgA < 12 IU/ml

No indication of recent exposure to the pathogen

Anti-PT IgG < 50 IU/ml and Anti-PT IgA ? 12 IU/ml

No indication of recent exposure to the pathogen

Anti-PT IgG 50 - 120 IU/ml and Anti-PT IgA < 12 IU/ml

No indication of recent exposure to the pathogen

Anti-PT IgG 50 - 120 IU/ml and Anti-PT IgA ? 12 IU/ml

Evidence of recent exposure to the pathogen

Anti-PT IgG > 120 IU/ml

Evidence of recent exposure to the pathogen

In ambiguous cases, testing a follow-up sample is recommended to document any increase in antibody titres due to recent infection.

Anti-B. pertussis Toxin IgA (Cat. no. ORG 916A)

Alegria Anti-B. pertussis Toxin IgA is an ELISA-based, automated, in-vitro test system for the quantitative determination of IgA antibodies against pertussis toxin in human serum or plasma.

Anti-B. pertussis Toxin IgG (Cat. no. ORG 916G)

Alegria Anti-B. pertussis Toxin IgG is is an ELISA-based, automated, in-vitro test system for the quantitative determination of IgG antibodies against pertussis toxin in human serum or plasma.

Format: Alegria® Monotest strips for the fully automated Alegria® / Alegria® 2 analyzers.

Specifications

Documents

• Instruction for Use – ORG 916A
• Safety Data Sheet – ORG 916A
• Instruction for Use – ORG 916G
• Safety Data Sheet – ORG 916G

Instruction for Use Revision 4. Earlier versions and additional languages can be found in the document archive.

Ordering Information