December 2024
NewsletterSummary:
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- Conversion of several antibody tests due to EU Regulation 2017/746 on In-vitro Diagnostics (IVDR)
- New ELISA tests replacing previous KBR tests for adenovirus, influenza A/B, Brucella, Campylobacter, Coxiella, and Yersinia
- Discontinuation of several tests due to unavailable reagents (including Neisseria gonorrhoeae, parainfluenza, Leptospira, RSV, rotavirus)
- Recommendation of PCR direct detection methods for respiratory and gastrointestinal infections
- Health insurance billing available for many of the recommended PCR tests
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Due to EU Regulation 2017/746 on In-vitro Diagnostics (IVDR), some reagents for antibody tests (AK) are no longer being manufactured. This also affects several tests from our routine diagnostics, which will be converted in the coming weeks. We provide you with an overview:
| Our conventional test | Planned changeover to: | Indications for the tests: |
| Adenovirus AK (CFT) |
Adenovirus-IgG (ELISA) Adenovirus-IgA (ELISA) |
In the acute phase, PCR is the diagnostic method of choice. Antibody testing is used to clarify manifestations such as hepatitis, meningoencephalitis, and cardiomyopathies. |
| Brucella spp. AK (CFT) |
Brucella abortus IgG (ELISA) Brucella abortus IgM (ELISA) |
For clarification of brucellosis (Bang’s disease). Brucella abortus occurs primarily in cattle and can be transmitted through direct contact, unpasteurized milk, and meat. |
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Campylobacter fetus AK (CFT) Campylobacter jejuni AK (CFT) |
Campylobacter jejuni-IgG (ELISA) Campylobacter jejuni-IgA (ELISA) |
In the acute infection phase, a stool culture at the Department of Hygiene and Medical Microbiology is recommended. Antibody testing is used to clarify secondary diseases such as reactive arthritis and neurological complications such as Guillain-Barré syndrome. |
| Influenza Virus A AK (CFT) |
Influenza A-IgG (ELISA) Influenza A-IgA (ELISA) |
In the acute phase, PCR is the diagnostic method of choice. Antibody diagnostics are used to clarify secondary diseases such as myocarditis or encephalitis. |
| Influenza Virus B AK (KBR) |
Influenza B-IgG (ELISA) Influenza B-IgA (ELISA) |
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| Q-Fieber (Coxiella) CFT |
Coxiella-frühe Phase IgG (ELISA) Coxiella späte Phase IgG (ELISA) Coxiella späte Phase IgM (ELISA) |
Suspicion of acute and chronic infections (e.g., atypical pneumonia, granulomatous hepatitis, endocarditis) with Coxiella burnetii (zoonosis). |
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Yersinia enterocolitica Sv3 (CFT) Yersinia enterocolitica Sv9 (CFT) Yersinia pseudotuberculosis (CFT) |
Yersinia enterocolitica IgG (ELISA) Yersinia enterocolitica IgA (ELISA) |
For clarification of acute enteritis, a stool culture at the Department of Hygiene and Medical Microbiology is recommended. Antibody diagnostics play an important role in clarifying mesenteric lymphadenitis, pseudoappendicitis, extramesenteric manifestations in various organs, as well as Yersinia-induced arthritis. |
Tests Being Removed from Our Service Catalog
Unfortunately, the following tests must be removed from our service catalog in the coming year because the corresponding reagents are no longer available:
- Neisseria gonorrhoeae AK (CFT)
- Parainfluenza Virus 1, Virus 2, Virus 3 AK (CFT)
- Leptospira AK (CFT)
- Respiratory Syncytial Virus AK (CFT)
- Rotavirus AK (CFT)
Our Recommendations
If you wish to clarify acute respiratory or gastrointestinal infections, we strongly recommend pursuing direct detection (PCR detection).
PCR tests for influenza viruses and RSV as well as Bordetella pertussis can best be performed from dry throat swabs and can be billed with all health insurance providers. The respiratory panel PCR can be offered for inpatient care, and Mycoplasma pneumoniae PCR is available at a private rate of €72.
The gastrointestinal panel is performed from stool samples and can also be billed with all health insurance providers.
Dr. Barbara Falkensammer
barbara.falkensammer@i-med.ac.at
+43 512 9003 71710