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different initiatives have been developed to improve diagnosis over the past years&#46; Based on lateral-flow paper-based technologies&#44;<a class="elsevierStyleCrossRef" href="#bib0070"><span class="elsevierStyleSup">5</span></a> the Alphakit Quickscreen &#40;Grifols&#44; Barcelona&#44; Spain&#41; has been marketed in Europe for the identification of the Z protein &#40;PiZ&#41; in serum&#46; Therefore&#44; the test allows the identification of the Z allele homozygous&#44; heterozygous and carries</p><p id="par0010" class="elsevierStylePara elsevierViewall">The opportunities for the diagnosis of AATD of such a test are clear&#44; since the on-site rapid and accurate identification of PiZ carriers may help identify AATD cases at an early stage with implications for management and family screening&#46; However&#44; the diagnostic accuracy of this test has been scarcely studied&#46; In the one real world evaluation of its performance available&#44;<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">6</span></a> the evaluation of the test&#39;s ability to detect the PiZ protein showed a specificity of 97&#46;8&#37;&#44; sensitivity of 73&#46;8&#37;&#44; negative predictive value of 98&#46;9&#37;&#44; and positive predictive value of 58&#46;5&#37;&#46; Of note&#44; after exploring the test-performance with different prevalence pre-test probability&#44; the authors found lower negative predictive values in a population with a very high pre-test probability&#46; Therefore&#44; the authors concluded that the device could be used as an appropriate tool to exclude AATD in primary care and in the overall COPD population&#44; except in patients with a high a priori-probability of AATD&#46; Additionally&#44; an added finding was that all false negatives &#40;<span class="elsevierStyleItalic">n</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>11&#41; were heterozygote Pi&#42;MZ samples&#44; with a correct identification of ZZ and SZ genotypes&#46; In this context&#44; an unexplored population of special interest is that with a low a priori pre-test probability of severe AATD defined as those with AAT serum concentration<span class="elsevierStyleHsp" style=""></span>&#62;<span class="elsevierStyleHsp" style=""></span>50 mg&#47;dl which are associated with increased risk for COPD<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">7</span></a>&#46; The identification of the Z allele in this population may help identifying Z carriers and advance in the early identification of treatable cases&#46;</p><p id="par0015" class="elsevierStylePara elsevierViewall">We performed a prospective&#44; single-center&#44; observational&#44; cross-sectional&#44; real-world analysis on the performance of Alphakit Quickscreen&#46; Following the Spanish recommendations&#44;<a class="elsevierStyleCrossRef" href="#bib0085"><span class="elsevierStyleSup">8</span></a> all patients referred to our COPD-dedicated outpatient clinic from January 2016 to July 2018 for a diagnosis of COPD had a serum AAT determination by nephelometry and those between 50 and 120<span class="elsevierStyleHsp" style=""></span>mg&#47;dL&#44; had an Alphakit Quickscreen determination done&#46; The test was performed complying with all the requirements of the manufacturer in the conservation and performance of the test&#46; The study was completed by allele-specific genotyping&#46; The diagnostic profile including the sensitivity&#44; specificity&#44; and the positive and negative predicted values for the identification of the Z allele was calculated together with the 95&#37; confidence interval &#40;95&#37;CI&#41;&#46; Data are expressed as absolute &#40;relative&#41; frequencies and mean &#40;standard deviation&#41; according to the variables&#8217; nature&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">The sample was composed of 16 subjects&#58; 11 &#40;68&#46;8&#37;&#41; males&#44; 58&#46;4 &#40;15&#46;3&#41; years of age&#44; 6 &#40;37&#46;5&#37;&#41; current smokers&#44; tobacco history 52&#46;7 &#40;31&#46;7&#41; pack-year&#44; body mass index 27&#46;7 &#40;6&#46;8&#41; kg&#47;m<span class="elsevierStyleSup">2</span>&#44; of which 12 &#40;75&#46;0&#37;&#41; fulfilled COPD diagnostic criteria with a post-bronchodilator FEV<span class="elsevierStyleInf">1</span> of 64&#46;3 &#40;18&#46;0&#41; &#37;&#46; Serum AAT concentrations varied from 56&#46;5 to 120&#46;0<span class="elsevierStyleHsp" style=""></span>mg&#47;dL&#44; with a mean value of 91&#46;7 &#40;20&#46;7&#41; mg&#47;dL&#46; The distribution of the Z alleles according to the Alphakit Quickscreen result is presented in <a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>&#46; The prevalence of the Z allele in this highly selected low-risk population of cases was 56&#46;2&#37; &#40;95&#37;CI 31&#46;9&#8211;80&#46;5&#41;&#46; The diagnostic profile of the test resulted in a specificity of 85&#46;71 &#40;95&#37;IC 68&#46;5&#8211;100&#41;&#44; sensitivity 88&#46;9 &#40;95&#37;IC 73&#46;5&#8211;100&#41;&#44; negative predictive value 85&#46;7 &#40;95&#37;CI 68&#46;5&#8211;100&#41;&#44; and positive predictive value 88&#46;9 &#40;95&#37;CI 73&#46;5&#8211;100&#41;&#46; We detected one false negative &#40;a SZ case with AAT serum concentration of 56&#46;5<span class="elsevierStyleHsp" style=""></span>mg&#47;dL&#41; and one false positive &#40;a MM case with AAT serum concentration of 120<span class="elsevierStyleHsp" style=""></span>mg&#47;dL&#41;&#46;</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0025" class="elsevierStylePara elsevierViewall">The Alphkit Quickscreen represents an attractive diagnostic method since it explores the presence of the Z protein using a non-invasive method and is freely distributed in the country by Grifols &#40;Grifols&#44; Barcelona&#44; Spain&#41;&#46; Our data show the diagnostic profile of Alphakit Quickscreen device in an a priori low probability of AATD cohort and additionally describing one case of a false negative in a SZ patient and a false positive in a MM case&#46; The main strength of our approach is the exploration of a specific subgroup of patients in which the test may be useful&#46; The limitation is the small sample size which is intrinsically associated with the population selection in a rare disease like AATD&#46; Therefore&#44; these findings should be confirmed in an independent cohort that includes these types of patients&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">The evaluation of the diagnostic profile of new diagnostic techniques is a necessary step before wide clinical implementation&#46; The one previous real-world available study evaluated 1019 samples in test-na&#239;ve COPD patients from 9 centers in Spain and 10 centers in Germany&#46; Patients included were &#8805;30 years of age and with a confirmed diagnosis of COPD&#44; with no exclusion criteria regarding the AAT serum levels&#46; Our study continues the evaluation of the Alphakit Quickscreen in a specific population which may be of interest for the identification of Z-allele carriers&#46; Our area has a lower prevalence of PI&#42;Z as compared to the rest of the country&#46;<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">9</span></a> As a quick&#44; easy&#44; point-of-care test&#44; this may have implications in the use of this test in future diagnostic algorithms&#46; Although this device allows for rapid analysis at the patient&#39;s point of care&#44; its actual position within a diagnostic algorithm as a screening tool needs to be assessed&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">Another interesting finding is the identification of one case of SZ which was a false negative&#44; as compared to the previous analysis in which all false negatives were MZ&#46;<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">6</span></a> False negatives in a lateral-flow analysis may be related to preservation&#44; technical performance or correct interpretation&#44; rather than the specific genotype&#46; Therefore&#44; it is expected that false negatives may affect different Z-allele carriers irrespective of the final genotype&#44; as the study of the test expands&#46; Moreover&#44; it would be interesting to confirm the genotype in all false negative and false positive cases by complete sequencing of coding exons of AAT gene&#46;</p><p id="par0040" class="elsevierStylePara elsevierViewall">In summary&#44; the evaluation of the performance of Alphakit Quickscreen in an a priori low risk of AATD population shows a diagnostic profile that allows it to be considered as a potential step in the diagnostic algorithm of AATD diagnosis&#46; Additionally&#44; this device represents a great opportunity to increase the awareness of AATD&#46;</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Conflicts of interest</span><p id="par0045" class="elsevierStylePara elsevierViewall">JLLC has received during the last 3 years personal fees or non-financial support from Grifols and CSL Behring&#46; The rest of the authors declare no conflicts of interest&#46;</p></span></span>"
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                  \t\t\t\t" scope="col">Genotype&nbsp;\t\t\t\t\t\t\n
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