How should human samples be handled according to the BioStoffV? – Part 1

According to TRBA 100 “Protective measures for activities with biological substances in laboratories” human sample materials (body fluids, tissues, cell cultures, etc.) whose infection status is not further characterized, are generally considered potentially infectious Therefore, the corresponding activities are generally carried out under conditions of Protection level 2 according to No. 5.3 TRBA 100.

However, if after characterization of human sample material from clinically normal donors no pathogens the Risk group 2 and higher, the conditions of the Protection level 1 according to No. 5.2 TRBA 100. This is the case, for example, if the sample materials are HIV-, HBV-, and HCV-negative after testing. While the risk of infection from other pathogens cannot be completely ruled out, it is negligible if general hygiene measures are observed.

Is the Infection status of the human sample material is known and an infection with HIV, HBV or HCV (according to TRBA 462 “Viruses” in Risk group 3 **), it must be checked activity-related according to the criteria mentioned in No. 4.3.2 whether the protective measures of the Protection level 2 according to No. 5.3 TRBA 100. This can be the case if the sample material is inactivated quickly or if a largely automated process (e.g. with a pipetting robot) is used. Otherwise, the protective measures of the Protection level 3 to be applied in accordance with No. 5.4.1 TRBA 100 (risk group 3**).

If the Infection status of the sample material is known, biological substances of Risk group 3 and the activities are not directed towards these (untargeted activity), the risk assessment must be carried out in accordance with the criteria set out in No. 4.3.2 TRBA 100 to check whether the protective measures of the Protection level 2 (No. 5.3 TRBA 100, if necessary with individual, additionally specified protective measures, are sufficient. If this is not the case, the activities must be carried out under the conditions of Protection level 3 in accordance with No. 5.4.2 TRBA 100 (risk group 3).

Lay Suspicions an infection with a biological agent of the Risk group 4 all preliminary investigations of the primary sample with non-inactivated material must be carried out at least under the conditions of Protection level 3 (No. 5.4.2 TRBA 100). For test samples from a facility contaminated with a biological agent of the Risk group 4 (e.g. Ebola virus) infected acutely ill Patients, laboratory diagnostic tests with non-inactivated material are carried out under the conditions of Protection level 4 according to No. 5.5 TRBA 100.

The third part of the series discusses how to handle human samples in the context of tuberculosis and anthrax diagnostics.