Missions

The Emergency and Certification Laboratory for Organs, Tissues, and Cells for transplanation is the only APHP virology laboratory open 24/7. It participates in ensuring the safety of transplants for a large population and is responsible for health and regulatory monitoring.
Its mission is:

• To respond to urgent requests:
  
  
  • Regulatory virological assessments for the qualification of deceased organ donors (subjects in a state of encephalic death and/or Maastricht category 2 or 3 circulatory arrest) originating from the Ile-de-France, Center-Val de Loire, and Normandy regions (nights and weekends).
  • Urgent serological examinations for hospitalized patients in health facilities in the Ile-de-France region when these examinations cannot be carried out onsite or during the opening hours of local laboratories (acute fulminant or acute hepatitis, accidental exposure to HIV, unfollowed pregnancy). 

• To carry out non-emergency virological assessment for the qualification of tissues and cells from tissue banks, cell therapy centers, hematology departments, etc. in the Assistance Publique-Hôpitaux de Paris or other hospitals.

Organization

This activity of the laboratory is open 24/7 and ensures the presence of technical and biological staff.

Assessments

The techniques used in this sector evolve according to improvements in tests available on the market, regulatory requirements, and recommendations of the health authorities: National Agency for the Safety of Medicines and Health Products (ANSM), Agence Biomedicine (ABM), and Directorate General of Health (DGS).

The assessments carried out as a part of donor qualification comply with current regulations.
Urgent assessments (excluding organ donation) are:

• Fulminant hepatitis: HBs Ag and anti-HBc IgM, HCV serology, anti-HAV IgM, anti-HEV IgM, and pre-transplant if prescribed; HIV, HTLV, CMV, and EBV serologies.
• Accidental exposure to HIV: for the source patient only, HIV serology.
• Unfollowed pregnancy: HBs antigen, and HIV and HCV serology, if prescribed.

All other requests are only accepted after agreement from the biologist.

Samples procedures

If the request is urgent, the laboratory must be notified.
For urgent requests, call the Henri-Mondor Hospital receptionist at 331 49 81 21 11 and specify that it is a "virological emergency".
The receptionist will then connect the applicant to the emergency technician. This service is available 24 hours a day, 7 days a week.

Samples must be accompanied by an application form, which must always include the following information:

• Identity of the patient (or the donor)
• Date and time of sampling
• Requesting agency
• Name of the prescribing doctor
• Name of the sample
• Telephone and fax numbers
• Reason for the request
• Marker(s) to search for (aside from regulatory assessment of donor organs)

The type of sample and quantity of tubes depends on the indication :

Storage conditions :

• Primary tubes: within 24 hours between 15°C and 25°C
• Centrifuged and decanted samples: within 3 days at +2°C to +8°C
• After 3 days: < -70°C

Transport :

• Urgent assessments :
  The samples must be sent to the laboratory rapidly (by courier or other means of rapid transport) and delivered by hand to the technician.
  If the laboratory is closed, the bell marked "virological emergencies" at the entrance should be used to signal the technician so that he/she comes to take the sample.
  The time of arrival at the laboratory will be specified on the voucher which will be signed by the person who receives the samples.

• Non-urgent assessments :
  Send (or drop off) the samples to the laboratory for virological emergencies and certifications, Department of Virology-Bacteriology-Hygiene, Mycology-Parasitology, Henri-Mondor Hospital.

Results :

• The maximum time limit for reporting the results of emergency samples is two hours for rapid HIV testing, three hours for unfollowed pregnancy tests and fulminant hepatitis, and four hours for organ donation.
• For non-emergency situations, results are reported between 24 h and five days maximum, according to the request.
• The results are given by fax and then by mail. No results are given over the phone.

All information and the exam guide are available in the sampling manual of the Biology-Pathology division of the Henri Mondor University Hospitals.