Background-There is increasing interest in the use of non-invasive nocturnal intermittent positive pressure ventilation (NIPPV) in the management of patients with chronic hypercapnoeic (type II) respiratory failure. Although this treatment enables patients requiring mechanical ventilatory support to be treated more readily at home, few studies have been done to demonstrate its long term benefits in chronic obstructive pulmonary disease (COPD) and the application of NIPPV in these circumstances remains controversial. Methods-Eleven patients in severe stable chronic type II respiratory failure due to COPD who were unresponsive to conventional treatments experienced symptomatic hypercapnia when receiving suYcient supplementary oxygen to result in an arterial oxygen saturation (SaO 2 ) of >90%. They were assessed for treatment with NIPPV, and its eVects were observed for over two years using arterial blood gas tensions, spirometric parameters and body mass index (BMI), survival, hospital admissions, use of general practitioner resources, and patient satisfaction. Results-Hospital admissions and GP consultations were halved after one year compared with the year before NIPPV and there was a sustained improvement in arterial blood gas tensions at 12 and 24 months when breathing air, despite progressive deterioration in ventilatory function. BMI did not change during the period of observation. The median survival was 920 days, with no patient dying within the first 500 days. Conclusions-Domiciliary NIPPV results in improvements in arterial blood gas tensions which are sustained after two years of treatment and reduces both hospital admissions and general practitioner visits by patients with severe COPD in hypercapnoeic respiratory failure. It is well tolerated and, although there was no control group, survival appears to be prolonged when these results are compared with those of the NOTT and MRC (LTOT) trials. (Thorax 1998;53:495-498) Keywords: home ventilation; chronic obstructive pulmonary disease; outcome measures Non-invasive positive pressure ventilation (NIPPV) is a well established form of treatment for chronic hypercapnoeic (type II) respiratory failure in patients with neuromuscular disease or skeletal deformity. Although there has been increasing interest in its use for patients in chronic type II respiratory failure due to chronic obstructive pulmonary disease (COPD), its use remains controversial in this group of patients with conflicting reports of its eYcacy and acceptability. MethodsEleven patients, all ex-smokers in severe type II respiratory failure, were electively admitted between 1991 and 1995. All were diagnosed as having COPD and were receiving maximal drug therapy. Long term oxygen therapy (LTOT) suYcient to correct hypoxaemia (SaO 2 >90%) resulted in symptomatic hypercapnia, especially morning headaches and excessive diurnal somnolence. Sleep apnoea syndrome was excluded (apnoea/hypnoea index <10) but patients 1, 3, 7, 8, 9, and 10 (table 1) experienced severe sleep hypoventilation....

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Human epididymis protein 4 (HE4), a member of Whey acidic four-disulfide core protein (WFDC) family, was demonstrated as one of the most useful biomarkers for ovarian cancer (HellstrÖm I, et al. 2003; Drapkin R, et al. 2005; Moore RG, et al. 2007).This study was to evaluate the use of Lumipulse G HE4 assay with patient serum for monitoring recurrence and progression of epithelial ovarian cancer. Recently, Lumipulse G HE4 assay was cleared by US FDA as an aid in monitoring recurrence or progressive disease in patients with epithelial ovarian cancer. Methods: Lumipulse G HE4 is a Chemiluminescent Enzyme Immunoassay (CLEIA) for the quantitative determination of HE4 in human serum and plasma on the Lumipulse G System by a two-step sandwich immunoassay method. In the assay, serum was added to and incubated with an anti-HE4 monoclonal antibody (MAb)-linked magnetic particles. The particles were then washed and rinsed to remove unbound materials. Alkaline phosphatase-labeled 2nd anti-HE4 MAb was added to and incubated with the HE4-bound particles. The particles were then washed and rinsed again to remove unbound materials. Substrate 3-(2’-spiroadamantane)-4-methoxy-4-(3”-phosphoryloxy) phenyl-1, 2-dioxetane disodium salt (AMPPD) solution was then added to and mixed with the particles. Luminescence signals were thus generated by the cleavage of dephosphorylated AMPPD and converted into the amount of HE4 in the serum. Results: In the monitoring study, changes in HE4 levels in serial serum samples collected in SST tubes from 72 subjects with epithelial ovarian cancer were compared to changes in disease status, that is, progression or no progression. A total of 330 observations were undertaken with an average number of 5.6 observations per subject. A positive change in the HE4 value was defined as an increase in the observation value that was at least 18% greater than the previous observation value. Of the 61 samples with a positive change, 49% of them correlated with the progression of epithelial ovarian cancer while 80% of the 269 subject serial samples with no significant change in the HE4 value correlated with no progression. The total concordance was 74%, positive predictive values (PPV) 35%, and negative predictive value (NPV) 87%. In addition, a comparison of Lumipulse G HE4 with the predicate device, HE4 EIA, was carried out using specimens consistent with CLSI Protocol EP09-A3 and weighted Deming regression analysis. The slope and correlation coefficient (r) obtained were 1.03 and 0.9891, respectively, for the tested specimens (n = 143) which ranged from 33.4 - 969.5 pmol/L, and slope and r of 1.03 and 0.9917, respectively, for the tested specimens (n = 168) ranged from 33.4 - 4602.0 pmol/L. Conclusion: The Lumipulse G HE4 assay has demonstrated to be useful in monitoring the course of disease in women with epithelial ovarian cancer and well correlated with the predicate device HE4 EIA. Citation Format: Rachel Radwan, Anders Öhrvik, Katherine Falcone, Sara Gannon, Candice Felman, Natalya Benina, Natascha Svensson, Savitha Raju, Sharee Jones, Catherine Peacock, Julianna Young, Zhong-Qian Li, Christian Fermer, Diana Dickson. Lumipulse G HE4 assay for monitoring of ovarian cancer recurrence and progression. [abstract]. In: Proceedings of the 107th Annual Meeting of the American Association for Cancer Research; 2016 Apr 16-20; New Orleans, LA. Philadelphia (PA): AACR; Cancer Res 2016;76(14 Suppl):Abstract nr 437.

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