Human immunodeficiency virus 1 dual-target nucleic acid technology improves blood safety: 5 years of experience of the German Red Cross blood donor service Baden-Württemberg-Hessen.

BACKGROUND: RNA viruses are associated with a high frequency of mutations because of the missing proofreading function of polymerases, such as reverse transcriptase. Between 2007 and 2010, six blood donations with false-negative nucleic acid technology (NAT) results were reported in Germany. Therefore, NAT screening in two viral genome regions was introduced by our blood donation service in 2010 on a voluntary basis and became mandatory in Germany since the beginning of 2015. STUDY DESIGN AND METHODS: Blood donor screening was done using, in parallel, the German Red Cross (GRC) HIV-1 CE long terminate repeats (LTR) PCR kit and the GRC HIV-1 gag CE PCR kit. In total, 7 million blood donations were screened during the study period from 2010 to 2014 with the GRC dual-target human immunodeficiency virus 1 (HIV-1) NAT system. Additionally, three suspicious specimens were analyzed by four monotargeted NAT assays and by five dual-target NAT assays. RESULTS: Three of 7 million donations tested negative using the 5'LTR-polymerase chain reaction, but they were positive if amplification was performed in the gag region. HIV antibodies were detected in all three donations. Nucleic acid sequence analysis identified a deletion of 22 bases within the 5'LTR probe binding region. Three different ltr-based monotargeted assays missed two donations, except for a low-reactive result obtained by one of the assays. In total, the detection rates for HIV-1-positive donations were 37.5% (3/8) for monotargeted assays and 100% (10/10) for dual-target assays. CONCLUSION: The current data demonstrate that dual-target NAT systems reduce the risk of false-negative HIV-1 NAT screening results.

Time-dependent changes of hs-CRP serum concentration in patients with non-ST elevation acute coronary syndrome.

BACKGROUND: Atherosclerosis is typically associated with a low-grade vascular inflammation that can be measured with the highly sensitive C-reactive protein (hs-CRP) assay. Actually, acute coronary syndromes are thought to result from plaque rupture which is induced by the inflammatory process in the atherosclerotic tissue. Therefore, it is interesting to discuss the value of follow-up measurements of hs-CRP in patients with coronary artery disease (CAD). PATIENTS AND METHODS: The hs-CRP concentration of 133 patients consecutively admitted with an acute coronary syndrome (ACS) was measured on admission and after 6 months. The final assessment after 3 years was structured by questionnaire. RESULTS: 17 cardiac events occurred within 6 months, 30 during the following 3 years. The hs-CRP levels (median +/- SEM) decreased significantly (p < 0.001) from baseline (3.9 +/- 1.3 mg/l) to follow-up (2.9 +/- 0.9 mg/l). Subdivision according to cardiac events during the first observation period confirmed this decrease in patients without events (baseline: 3.9 +/- 1.5 mg/l, follow-up: 2.9 +/- 0.9 mg/l; p < 0.001), whereas patients with events showed a persistent elevation (baseline: 3.8 +/- 0.9 mg/l, follow-up: 4.1 +/- 1.0 mg/l; p = 0.426). Patients who developed a further event during the 6-month period showed hs-CRP levels at follow-up that were > 60% of the initial level. Interestingly, 80% of the events within the following 3 years occurred in patients with an hs-CRP level above this discriminator. With a follow-up hs-CRP value above this discriminator the relative risk of suffering an event was 3.4 (95% confidence interval 1.27-8.9; p < 0.05). CONCLUSION: Patients with a non-ST elevation ACS who showed no event within 6 months are characterized by a decrease in hs-CRP levels from baseline to follow-up. Most events in the observation period of 3 years occurred in patients with follow-up hs-CRP levels > 60% of the initial level. Therefore, it was hypothesized that a repeated measurement of hs-CRP levels in CAD patients could help to discriminate those at high risk of further events.