{"id":140426,"date":"2024-03-26T09:20:42","date_gmt":"2024-03-26T12:20:42","guid":{"rendered":"https:\/\/controllab.com\/?p=140426"},"modified":"2024-06-14T11:23:24","modified_gmt":"2024-06-14T14:23:24","slug":"batch-certification-of-pocts-meets-the-needs-of-those-conducting-clinical-analysis-exams","status":"publish","type":"post","link":"https:\/\/controllab.com\/en\/batch-certification-of-pocts-meets-the-needs-of-those-conducting-clinical-analysis-exams\/","title":{"rendered":"Batch certification of POCTs meets the needs of those conducting clinical analysis exams"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"140426\" class=\"elementor elementor-140426 elementor-140421\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"has_ae_slider elementor-section elementor-top-section elementor-element elementor-element-a293d82 elementor-section-boxed elementor-section-height-default elementor-section-height-default ae-bg-gallery-type-default\" data-id=\"a293d82\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"has_ae_slider elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-9d72c0b ae-bg-gallery-type-default\" data-id=\"9d72c0b\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-7553a01 elementor-widget elementor-widget-text-editor\" data-id=\"7553a01\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><em>Initiative promotes increased reliability for analytical routines and greater safety for patients.<\/em><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"has_ae_slider elementor-section elementor-top-section elementor-element elementor-element-1cfc6bd elementor-section-boxed elementor-section-height-default elementor-section-height-default ae-bg-gallery-type-default\" data-id=\"1cfc6bd\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"has_ae_slider elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-8a0a47f ae-bg-gallery-type-default\" data-id=\"8a0a47f\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-52311f5 elementor-widget elementor-widget-text-editor\" data-id=\"52311f5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Clinical analysis establishments need to implement a <strong>quality assurance program for their results<\/strong> to manage risks and ensure patient safety.<\/p><p>These guidelines are essential to prevent deviations in reports and to promote the credibility of the establishment with the public. They are defined by government regulations, such as <a href=\"https:\/\/www.in.gov.br\/en\/web\/dou\/-\/resolucao-rdc-n-786-de-5-de-maio-de-2023-482394228?_ga=2.19013887.678390399.1704716165-205866377.1690466171\" target=\"_blank\" rel=\"noopener\">RDC 786\/2023<\/a>, or by laboratory accreditation standards such as ISO 15189, PALC-SBPC\/ML, DICQ-SBAC, among others.<\/p><p>The pursuit of excellence underscores the importance of quality control practices in maintaining rigorous standards. Within these practices, it is essential to ensure that the replacement of <strong>reagent batches does not affect analytical routines<\/strong>, as recommended by national and international reference sources such as <a href=\"https:\/\/clsi.org\/standards\/products\/method-evaluation\/documents\/ep26\/\" target=\"_blank\" rel=\"noopener\">CLSI EP26<\/a>.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"has_ae_slider elementor-section elementor-top-section elementor-element elementor-element-fa50985 elementor-section-boxed elementor-section-height-default elementor-section-height-default ae-bg-gallery-type-default\" data-id=\"fa50985\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"has_ae_slider elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-fd54e40 ae-bg-gallery-type-default\" data-id=\"fd54e40\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-7417bcf elementor-widget elementor-widget-heading\" data-id=\"7417bcf\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h5 class=\"elementor-heading-title elementor-size-default\">Innovative program<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"has_ae_slider elementor-section elementor-top-section elementor-element elementor-element-bdb6269 elementor-section-boxed elementor-section-height-default elementor-section-height-default ae-bg-gallery-type-default\" data-id=\"bdb6269\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"has_ae_slider elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-0c916f0 ae-bg-gallery-type-default\" data-id=\"0c916f0\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-7d84f68 elementor-widget elementor-widget-text-editor\" data-id=\"7d84f68\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><a href=\"http:\/\/controllab.com\/en\">Controllab<\/a>, a reference in solutions for quality control of analyses, offers the <strong>Lot-to-Lot Certification Program<\/strong> for POCT device manufacturers with visual and automated reading.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"has_ae_slider elementor-section elementor-top-section elementor-element elementor-element-c2322bf elementor-section-boxed elementor-section-height-default elementor-section-height-default ae-bg-gallery-type-default\" data-id=\"c2322bf\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"has_ae_slider elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-902efa3 ae-bg-gallery-type-default\" data-id=\"902efa3\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-01bf5bf elementor-widget elementor-widget-text-editor\" data-id=\"01bf5bf\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>In this program, batches of these products are evaluated according to the main guidelines and related literature, using representative materials from routine. The goal is to verify if the results obtained between batches are consistent and maintain analytical performance.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"has_ae_slider elementor-section elementor-top-section elementor-element elementor-element-c43e2a8 elementor-section-boxed elementor-section-height-default elementor-section-height-default ae-bg-gallery-type-default\" data-id=\"c43e2a8\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"has_ae_slider elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-d7a8bc9 ae-bg-gallery-type-default\" data-id=\"d7a8bc9\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-10bdba5 elementor-widget elementor-widget-text-editor\" data-id=\"10bdba5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Manufacturers that submit their devices to the program meet the needs of laboratories, pharmacies, clinics, and offices, helping them reduce costs and efforts in monitoring the replacement of new reagents in the analytical routine, promoting:<\/p><ul><li><strong>risk reduction;<\/strong><\/li><li><strong>greater patient safety;<\/strong><\/li><li><strong>confidence in the product.<\/strong><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"has_ae_slider elementor-section elementor-top-section elementor-element elementor-element-3fe0122 elementor-section-boxed elementor-section-height-default elementor-section-height-default ae-bg-gallery-type-default\" data-id=\"3fe0122\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"has_ae_slider elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-20f869d ae-bg-gallery-type-default\" data-id=\"20f869d\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-aa7924c elementor-widget elementor-widget-text-editor\" data-id=\"aa7924c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Furthermore, manufacturers demonstrate quality to the market and assist clinical analysis establishments in evidencing compliance with regulatory and legal guidelines.<\/p><p>In this scenario, <a href=\"https:\/\/grupokovalent.com.br\/quem-somos\/\" target=\"_blank\" rel=\"noopener\">Grupo Kovalent<\/a>, committed to quality requirements and its audience, is at the forefront in ensuring certification for a selection of its products. The following batches are already certified:<\/p><ul><li><strong><a href=\"https:\/\/controllab.com\/wp-content\/uploads\/Lote-PSTXA06X.pdf\">PSTXA06X<\/a><\/strong> e <strong><a href=\"https:\/\/controllab.com\/wp-content\/uploads\/Lote-PSTEA04X.pdf\">PSTEA04X<\/a><\/strong> (AFIAS PSA Neo);<\/li><li><strong><a href=\"https:\/\/controllab.com\/wp-content\/uploads\/Lote-TSTHA12X.pdf\">TSTHA12X<\/a><\/strong> e <strong><a href=\"https:\/\/controllab.com\/wp-content\/uploads\/Lote-TSTEA05X.pdf\">TSTEA05X<\/a><\/strong> (AFIAS TSH);<\/li><li><strong><a href=\"https:\/\/controllab.com\/wp-content\/uploads\/Lote-AATHA61X.pdf\">AATHA61X<\/a><\/strong> (AFIAS HbA1c Neo);<\/li><li><strong><a href=\"https:\/\/controllab.com\/wp-content\/uploads\/Lote-VETYA68X.pdf\">VETYA68X<\/a><\/strong> (AFIAS Vitamin D Neo) e<\/li><li><strong><a href=\"https:\/\/controllab.com\/wp-content\/uploads\/Lote-HBPTH17.pdf\">HBPTH17<\/a><\/strong> (Microcuvettes).<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"has_ae_slider elementor-section elementor-top-section elementor-element elementor-element-cd6ca97 elementor-section-boxed elementor-section-height-default elementor-section-height-default ae-bg-gallery-type-default\" data-id=\"cd6ca97\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"has_ae_slider elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-838429d ae-bg-gallery-type-default\" data-id=\"838429d\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-83bf22c elementor-widget elementor-widget-text-editor\" data-id=\"83bf22c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>The <strong>Lot-to-Lot Certification Program<\/strong> is an innovative initiative for the segment in Brazil. This pioneering spirit is a hallmark of Controllab, known for competence, experience, trust, and innovation. The company is recognized by the main standards related to its operations: <strong>ISO 9001<\/strong>, <strong>17025<\/strong>, <strong>17034<\/strong>, and <strong>17043<\/strong>.<\/p><p>For more information about the Lot-to-Lot Certification Program and other solutions for quality control of analyses, <a href=\"https:\/\/api.whatsapp.com\/send?phone=5521982580074\" target=\"_blank\" rel=\"noopener\">contact Controllab<\/a>.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Initiative promotes increased reliability for analytical routines and greater safety for patients. Clinical analysis establishments need to implement a quality assurance program for their results to<span class=\"excerpt-hellip\"> [\u2026]<\/span><\/p>\n","protected":false},"author":1,"featured_media":140423,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[2586,2592],"tags":[1793,1791,1783,1792,1784,703,1785,1794,1786],"class_list":["post-140426","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-batch-by-batch","category-poct-en-2","tag-analytical-routines","tag-batch-certification-of-pocts","tag-certificacao-de-lotes-pocts-en","tag-clinical-analysis-exams","tag-exames-de-analises-clinicas-en","tag-reliability","tag-rotinas-analiticas-en","tag-safety","tag-seguranca-en"],"acf":[],"_links":{"self":[{"href":"https:\/\/controllab.com\/en\/wp-json\/wp\/v2\/posts\/140426","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/controllab.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/controllab.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/controllab.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/controllab.com\/en\/wp-json\/wp\/v2\/comments?post=140426"}],"version-history":[{"count":0,"href":"https:\/\/controllab.com\/en\/wp-json\/wp\/v2\/posts\/140426\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/controllab.com\/en\/wp-json\/wp\/v2\/media\/140423"}],"wp:attachment":[{"href":"https:\/\/controllab.com\/en\/wp-json\/wp\/v2\/media?parent=140426"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/controllab.com\/en\/wp-json\/wp\/v2\/categories?post=140426"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/controllab.com\/en\/wp-json\/wp\/v2\/tags?post=140426"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}