HIV and hepatitis B/C infections in patients donating blood for use as autologous serum eye drops

During recent years eye drops from autologous serum have become increasingly popular for treating ocular surface disorders such as persistent corneal epithelial defects and severe forms of dry eye.¹,²,³,⁴ Although very successful, one potential disadvantage of this approach—especially because the drops are used in a domestic setting—is the possibility of transmission of viral infections by the erroneous application of the eye drops to the wrong recipient. In a diagnostic laboratory, one single droplet of serum has been reported to have transmitted HIV to a laboratory technician.⁵ However, serological testing of patients who donate autologous serum is not generally established and there has been no report published so far analysing the rate of unknown viral infections in potential donors of autologous serum eye drops.¹,²,³,⁴

Case report

We report the results of HIV and hepatitis‐B/C serology testing in patients donating blood for the production of autologous serum eye drops at our centre. During the period August 2005 to November 2006, 88 patients with persistent corneal epithelial defects or severe forms of dry eye were referred to the department of transfusion medicine to donate autologous serum (156 visits, between one and 12 visits per individual patient). Table 1 shows the result of 88 patients tested for HIV, HBV, and HCV infection by serology in comparison with new blood donors in Germany in 2004.⁶ In our patients, positive results in screening tests were confirmed according to the procedures which are established for blood donors—that is, HIV immunoblot and HIV RNA NAT, HBsAg neutralisation assay and HBV DNA NAT, HCV immunoblot, and HCV RNA NAT.⁶ In summary, 2.3% of all patients showed previously unknown viral infections with hepatitis B or C virus. The finding of a comparably high rate of infections in our small number of autologous donors of serum eye drops is surprising, but in line with our previous report on patients undergoing preoperative autologous blood donation (PABD), where we found a rate of about 20% of patients with positive markers for HIV, HCV, HBV (including anti‐HBc) or syphilis infection.⁷ In addition to the confirmed infections shown in table 1, we found that one of our patients was positive for anti‐HIV (HIV RNA NAT negative, HIV immunoblot inconclusive), one patient had antibodies against Treponema pallidum, and three patients were positive for anti‐HBc, resulting in an overall rate of 8% of patients with positive infection markers in the study.

Table 1 Number of HIV, HCV, or HBV infections in patients intending to donate blood for use as autologous serum eye drops, compared with new blood donors in Germany in 2004⁶.

	No of individuals tested	No of patients/donors with infection			Overall proportion of individuals with infection
		HIV	HCV	HBV
Present study	88	0	1 (1.1%)	1 (1.1%)	2.3%
New blood donors6	per 100 000	6.3 (0.006%)	102.7 (0.1%)	136.2 (0.1%)	0.2%

HBV, hepatitis B virus; HCV, hepatitis C virus; HIV, human immunodeficiency virus.

Comment

In blood transfusion, the risk of receiving a blood component which was intended for a different patient is about 1:10 000.⁸ This refers to a standardised procedure carried out by trained staff in a controlled hospital setting and led to the recommendation that all PABD patients in Germany should be tested for HIV, HCV, and HBV. In outpatient practice, discrepancies over the dosage of drugs, taking drugs that were not recorded, or not taking a recorded drug were reported in 76% of patients.⁹ Serum eye drops are normally used in an “uncontrolled” outpatient setting. This suggests that the risk that autologous serum eye drops are not given to the intended patient or are unintentionally used by someone else at home (for example, children), and therefore give rise to the transmission of viral infection, might be considerably greater than 1:10 000. This strongly suggests that virology screening should be carried out in all patients undergoing donation for autologous serum eye drops.

In conclusion, significant proportions of patients intending to donate blood for use as autologous serum eye drops show infections with hepatitis B and C virus and should therefore generally be tested for HIV, HCV, and HBV infection. Patients with viral infections should not be allowed to donate autologous serum eye drops, to prevent the risk of viral transmission by unintended use of autologous serum eye drops by a third party. This principle should generally be applied in all cases where autologous blood is drawn and stored for therapeutic purposes.