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Designated Lab Network!</H2></h2> </div> </div> <div class="elementor-element elementor-element-5a1c89b elementor-widget elementor-widget-text-editor" data-id="5a1c89b" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p><span style="font-weight: 400;">SalivaDirect™ is a PCR test that uses saliva to detect SARS-CoV-2 in patients two (2) years and older. Our flexible, extraction-free method is designed to be a cost-effective, simple test for laboratories, enabling them to achieve higher throughput and faster results. </span></p><p><span style="font-weight: 400;">The U.S. FDA granted the SalivaDirect</span><span style="font-weight: 400;">™</span><span style="font-weight: 400;"> EUA (<a href="https://www.fda.gov/media/141194/download">EUA 202097</a>) in August 2020 and authorized SalivaDirect, Inc.* to extend the EUA to designated CLIA laboratories across the country. SalivaDirect, Inc. has designated more than 200 labs in 42 states. High-complexity laboratories in the U.S. can be designated to perform the SalivaDirect</span><span style="font-weight: 400;">™</span><span style="font-weight: 400;"> test. </span></p><p>Qualified labs are invited to join our network. With documents in hand, most labs complete the designation process within one week. </p> </div> </div> <div class="elementor-element elementor-element-85460d9 elementor-align-center elementor-widget elementor-widget-button" data-id="85460d9" data-element_type="widget" data-widget_type="button.default"> <div class="elementor-widget-container"> <div class="elementor-button-wrapper"> <a class="elementor-button elementor-button-link elementor-size-sm" href="https://docs.google.com/forms/d/e/1FAIpQLScBFTyNBLYAjjv96QgIkw3L9NcG78p5cbYrmkIzR1gJFYa-Cg/viewform"> <span class="elementor-button-content-wrapper"> <span class="elementor-button-text">Apply Now</span> </span> </a> </div> </div> </div> <div class="elementor-element elementor-element-4442f9b elementor-widget elementor-widget-text-editor" data-id="4442f9b" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p><i><span style="font-weight: 400;">*The EUA was initially authorized to designate labs under Yale School of Public Health.</span></i></p> </div> </div> </div> </div> </div> </div> </div> <div class="elementor-element elementor-element-66c1fd9 elementor-hidden-mobile e-flex e-con-boxed e-con e-parent" data-id="66c1fd9" data-element_type="container"> <div class="e-con-inner"> <div class="elementor-element elementor-element-cc6da8e e-con-full e-flex e-con e-child" data-id="cc6da8e" data-element_type="container"> <div class="elementor-element elementor-element-f011f4b e-con-full e-flex e-con e-child" data-id="f011f4b" data-element_type="container"> <div class="elementor-element elementor-element-e7c5bbb e-con-full card-first-circle e-flex e-con e-child" data-id="e7c5bbb" data-element_type="container" data-settings="{"background_background":"classic","position":"absolute"}"> </div> <div class="elementor-element elementor-element-5b084a9 e-con-full card-first-circle e-flex e-con e-child" data-id="5b084a9" data-element_type="container" data-settings="{"background_background":"classic","position":"absolute"}"> </div> <div class="elementor-element elementor-element-b30b461 e-con-full header-title e-transform e-flex e-con e-child" data-id="b30b461" data-element_type="container" data-settings="{"_transform_translateX_effect":{"unit":"px","size":"","sizes":[]},"_transform_translateX_effect_tablet":{"unit":"px","size":"","sizes":[]},"_transform_translateX_effect_mobile":{"unit":"px","size":"","sizes":[]},"_transform_translateY_effect":{"unit":"px","size":"","sizes":[]},"_transform_translateY_effect_tablet":{"unit":"px","size":"","sizes":[]},"_transform_translateY_effect_mobile":{"unit":"px","size":"","sizes":[]}}"> <div class="elementor-element elementor-element-d387e65 elementor-widget elementor-widget-heading" data-id="d387e65" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h2 class="elementor-heading-title elementor-size-default">Have Questions About Offering SalivaDirect™? </h2> </div> </div> <div class="elementor-element elementor-element-17de66d card-button elementor-widget elementor-widget-button" data-id="17de66d" data-element_type="widget" data-widget_type="button.default"> <div class="elementor-widget-container"> <div class="elementor-button-wrapper"> <a class="elementor-button elementor-button-link elementor-size-sm" href="/cdn-cgi/l/email-protection#523b3c343d1221333e3b2433363b203731267c3d2035"> <span class="elementor-button-content-wrapper"> <span class="elementor-button-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-fas-arrow-right" viewBox="0 0 448 512" xmlns="http://www.w3.org/2000/svg"><path d="M190.5 66.9l22.2-22.2c9.4-9.4 24.6-9.4 33.9 0L441 239c9.4 9.4 9.4 24.6 0 33.9L246.6 467.3c-9.4 9.4-24.6 9.4-33.9 0l-22.2-22.2c-9.5-9.5-9.3-25 .4-34.3L311.4 296H24c-13.3 0-24-10.7-24-24v-32c0-13.3 10.7-24 24-24h287.4L190.9 101.2c-9.8-9.3-10-24.8-.4-34.3z"></path></svg> </span> <span class="elementor-button-text">Email Us</span> </span> </a> </div> </div> </div> </div> <div class="elementor-element elementor-element-f8d1ea8 elementor-absolute card-image elementor-widget elementor-widget-image" data-id="f8d1ea8" data-element_type="widget" data-settings="{"_position":"absolute"}" data-widget_type="image.default"> <div class="elementor-widget-container"> <img decoding="async" width="1320" height="880" src="https://salivadirectinc.org/wp-content/uploads/2024/11/608053330ab54ca9f4b8fa7e09016956-2.webp" class="elementor-animation-grow attachment-full size-full wp-image-1060" alt="" srcset="https://salivadirectinc.org/wp-content/uploads/2024/11/608053330ab54ca9f4b8fa7e09016956-2.webp 1320w, https://salivadirectinc.org/wp-content/uploads/2024/11/608053330ab54ca9f4b8fa7e09016956-2-300x200.webp 300w, https://salivadirectinc.org/wp-content/uploads/2024/11/608053330ab54ca9f4b8fa7e09016956-2-1024x683.webp 1024w, https://salivadirectinc.org/wp-content/uploads/2024/11/608053330ab54ca9f4b8fa7e09016956-2-768x512.webp 768w" sizes="(max-width: 1320px) 100vw, 1320px" /> </div> </div> </div> </div> </div> </div> <div class="elementor-element elementor-element-cf23e3f e-flex e-con-boxed e-con e-parent" data-id="cf23e3f" data-element_type="container" id="laboratory-designation-process"> <div class="e-con-inner"> <div class="elementor-element elementor-element-923c3f6 e-con-full e-flex e-con e-child" data-id="923c3f6" data-element_type="container"> <div class="elementor-element elementor-element-df425b0 e-con-full e-flex e-con e-child" data-id="df425b0" data-element_type="container"> <div class="elementor-element elementor-element-f150897 elementor-widget elementor-widget-heading" data-id="f150897" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h3 class="elementor-heading-title elementor-size-default"><H2>Laboratory Designation Process</h2></h3> </div> </div> <div class="elementor-element elementor-element-77b164b elementor-widget elementor-widget-text-editor" data-id="77b164b" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p>Clinical laboratories interested in being designated to offer SalivaDirect™ as part of their laboratory services must <a href="https://docs.google.com/forms/d/e/1FAIpQLScBFTyNBLYAjjv96QgIkw3L9NcG78p5cbYrmkIzR1gJFYa-Cg/viewform">apply</a> to join the network. SalivaDirect, Inc. will review each application to determine eligibility. If your lab is eligible to join the network, you will complete the following steps:</p><ol><li dir="ltr"><p dir="ltr" role="presentation">Perform the SalivaDirect™ protocol using the Instructions for Use </p></li><li dir="ltr"><p dir="ltr" role="presentation">Provide testing verification data demonstrating mastery of the SalivaDirect™ protocol </p></li><li dir="ltr"><p dir="ltr" role="presentation">Complete the Designated Laboratory Agreement</p></li><li dir="ltr"><p dir="ltr" role="presentation">Receive access to training and documents for the SalivaDirect™ protocol in our Lab Portal</p></li></ol> </div> </div> </div> </div> </div> </div> <div class="elementor-element elementor-element-f7f3ad1 e-flex e-con-boxed e-con e-parent" data-id="f7f3ad1" data-element_type="container" id="sd-protocol"> <div class="e-con-inner"> <div class="elementor-element elementor-element-ec1f225 e-con-full e-flex e-con e-child" data-id="ec1f225" data-element_type="container"> <div class="elementor-element elementor-element-4b66360 elementor-widget elementor-widget-heading" data-id="4b66360" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h2 class="elementor-heading-title elementor-size-default"><H2> The SalivaDirect™ Protocol</H2></h2> </div> </div> <div class="elementor-element elementor-element-31d4392 elementor-widget elementor-widget-text-editor" data-id="31d4392" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p>The SalivaDirect<span style="font-weight: 400;">™</span> protocol is authorized for emergency use by the U.S. Food and Drug Administration to diagnose COVID-19 in both symptomatic and asymptomatic individuals.</p><p>The SalivaDirect<span style="font-weight: 400;">™</span> protocol is one of the first diagnostic approaches to offer reagent and instrument-flexible capabilities, allowing labs to use several commercially available reagents and instruments from different suppliers. Validated across a wide range of reagents and instruments, the protocol can be seamlessly integrated into many existing lab setups reducing the barrier to entry for labs to begin providing COVID-19 diagnostic testing.</p><p>Testing is limited to laboratories designated by SalivaDirect, Inc. that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, and meet the requirements to perform high-complexity tests.</p> </div> </div> <div class="elementor-element elementor-element-8997c98 elementor-widget elementor-widget-heading" data-id="8997c98" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h4 class="elementor-heading-title elementor-size-default"><H3> How Does the SalivaDirect™ Protocol Work?</H3></h4> </div> </div> <div class="elementor-element elementor-element-282c93d elementor-widget elementor-widget-text-editor" data-id="282c93d" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p><span style="font-weight: 400;">The SalivaDirect™ protocol utilizes a nucleic acid extraction-free workflow paired with real-time reverse transcription polymerase chain reaction (RT-PCR) technology to detect SARS-CoV-2 RNA in saliva. The process involves <strong>the following steps</strong>:</span></p> </div> </div> <div class="elementor-element elementor-element-42d61f0 e-n-tabs-none elementor-widget elementor-widget-n-tabs" data-id="42d61f0" data-element_type="widget" data-settings="{"tabs_justify_horizontal":"start","horizontal_scroll":"enable"}" data-widget_type="nested-tabs.default"> <div class="elementor-widget-container"> <div class="e-n-tabs" data-widget-number="70083056" aria-label="Tabs. Open items with Enter or Space, close with Escape and navigate using the Arrow keys."> <div class="e-n-tabs-heading" role="tablist"> <button id="e-n-tab-title-700830561" class="e-n-tab-title" aria-selected="true" data-tab-index="1" role="tab" tabindex="0" aria-controls="e-n-tab-content-700830561" style="--n-tabs-title-order: 1;"> <span class="e-n-tab-title-text"> 1. Saliva Collection </span> </button> <button id="e-n-tab-title-700830562" class="e-n-tab-title" aria-selected="false" data-tab-index="2" role="tab" tabindex="-1" aria-controls="e-n-tab-content-700830562" style="--n-tabs-title-order: 2;"> <span class="e-n-tab-title-text"> 2. Sample Preparation </span> </button> <button id="e-n-tab-title-700830563" class="e-n-tab-title" aria-selected="false" data-tab-index="3" role="tab" tabindex="-1" aria-controls="e-n-tab-content-700830563" style="--n-tabs-title-order: 3;"> <span class="e-n-tab-title-text"> 3. RT-qPCR </span> </button> </div> <div class="e-n-tabs-content"> <div id="e-n-tab-content-700830561" role="tabpanel" aria-labelledby="e-n-tab-title-700830561" data-tab-index="1" style="--n-tabs-title-order: 1;" class="e-active elementor-element elementor-element-810d142 e-con-full e-flex e-con e-child" data-id="810d142" data-element_type="container"> <div class="elementor-element elementor-element-9abfdc1 elementor-widget elementor-widget-text-editor" data-id="9abfdc1" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p><span style="font-weight: 400;">Patients provide a saliva sample by passively drooling into a sterile container or collection tube. Patients are advised not to eat or drink for 30 minutes before sample collection. </span><span style="font-weight: 400;">Saliva self-collection instructions can be accessed <a href="https://drive.google.com/file/d/1uAEs06cWTjw66cn9eBY3Q0ay0Ech-cdA/view">here</a></span>.</p> </div> </div> </div> <div id="e-n-tab-content-700830562" role="tabpanel" aria-labelledby="e-n-tab-title-700830562" data-tab-index="2" style="--n-tabs-title-order: 2;" class=" elementor-element elementor-element-f90ed27 e-con-full e-flex e-con e-child" data-id="f90ed27" data-element_type="container"> <div class="elementor-element elementor-element-a3337af elementor-widget elementor-widget-text-editor" data-id="a3337af" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p><span style="font-weight: 400;">The SalivaDirect™ protocol has been validated for use in three different nucleic acid extraction-free sample preparation workflows; these workflows utilize a combination of Proteinase K and/or heat pre-treatments. These treatments break down proteins in the saliva and help release viral RNA, thereby removing the need for lengthy and costly RNA extraction steps. Labs are able to use the workflow that best integrates with their operations.</span></p> </div> </div> </div> <div id="e-n-tab-content-700830563" role="tabpanel" aria-labelledby="e-n-tab-title-700830563" data-tab-index="3" style="--n-tabs-title-order: 3;" class=" elementor-element elementor-element-d4fb5b5 e-con-full e-flex e-con e-child" data-id="d4fb5b5" data-element_type="container"> <div class="elementor-element elementor-element-a63bfd2 elementor-widget elementor-widget-text-editor" data-id="a63bfd2" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p><span style="font-weight: 400;">After sample preparation, the sample is analyzed using one-step RT-PCR amplification to detect any SARS-CoV-2 RNA present. Fluorescently labeled primers and probes from various vendors have been evaluated and selected to ensure optimal sensitivity and specificity in detecting viral RNA. Several PCR instruments have also been validated. See the vendors below. </span></p> </div> </div> </div> </div> </div> </div> </div> <div class="elementor-element elementor-element-0863277 elementor-widget elementor-widget-heading" data-id="0863277" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h4 class="elementor-heading-title elementor-size-default"><H3>Technical Requirements</H3></h4> </div> </div> <div class="elementor-element elementor-element-bcfa76a elementor-widget elementor-widget-heading" data-id="bcfa76a" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h4 class="elementor-heading-title elementor-size-default"><H4>Sample Collection</h4></h4> </div> </div> <div class="elementor-element elementor-element-a195f7e elementor-widget elementor-widget-text-editor" data-id="a195f7e" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p><span style="font-weight: 400;">The SalivaDirect™ protocol has received EUA approval for three saliva sample collection methods:</span></p><ol><li>In the presence of a trained observer at a Designated Laboratory</li><li>At home using the SalivaDirect<span style="font-weight: 400;">™</span> At-home Collection Kit</li><li>At home using the SalivaDirect<span style="font-weight: 400;">™</span> Unsupervised Collection Kit</li></ol> </div> </div> <div class="elementor-element elementor-element-3d8cbe3 elementor-widget elementor-widget-heading" data-id="3d8cbe3" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h4 class="elementor-heading-title elementor-size-default"><h4>Reagents and Instruments</h4></h4> </div> </div> <div class="elementor-element elementor-element-5bb9905 elementor-widget elementor-widget-text-editor" data-id="5bb9905" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p><span style="color: var( --e-global-color-text ); font-family: var( --e-global-typography-text-font-family ), Sans-serif; font-size: var( --e-global-typography-text-font-size ); text-align: var(--text-align);">The SalivaDirect™ protocol has been validated for a wide range of reagents and instruments:</span></p> </div> </div> <div class="elementor-element elementor-element-a8a24b1 elementor-widget elementor-widget-text-editor" data-id="a8a24b1" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p><b>Reagents</b></p> </div> </div> <div class="elementor-element elementor-element-2ca4e85 elementor-widget elementor-widget-html" data-id="2ca4e85" data-element_type="widget" data-widget_type="html.default"> <div class="elementor-widget-container"> <style> td { background-color: white !important; font-size: 18px; font-family: montserrat; } td:hover { background-color: #F1F1F1 !important; } td, th { vertical-align: middle!important; padding-top: 25px!important; } </style> <table class="c15"> <tr class="c19"> <td class="c7" colspan="1" rowspan="1"> <p class="c5"><span class="c13 c3"><b>Reagent</b></span></p> </td> <td class="c10" colspan="1" rowspan="1"> <p class="c5"><span class="c13 c3"><b>Vendor</b></span></p> </td> <td class="c8" colspan="1" rowspan="1"> <p class="c5"><span class="c13 c3"><b>Item</b></span></p> </td> <td class="c6" colspan="1" rowspan="1"> <p class="c5"><span class="c13 c3"><b>Catalog Number(s)</b></span></p> </td> </tr> <tr class="c31"> <td class="c7" colspan="1" rowspan="3"> <p class="c5"><span class="c0">Proteinase K</span></p> </td> <td class="c10" colspan="1" rowspan="1"> <p class="c5"><span class="c0">ThermoFisher Scientific</span></p> </td> <td class="c8" colspan="1" rowspan="1"> <p class="c5"><span class="c0">MagMAX Viral/Pathogen Proteinase K</span></p> </td> <td class="c6" colspan="1" rowspan="1"> <p class="c5"><span class="c26">A42363</span></p> </td> </tr> <tr class="c18"> <td class="c10" colspan="1" rowspan="1"> <p class="c5"><span class="c0">New England Biolabs</span></p> </td> <td class="c8" colspan="1" rowspan="1"> <p class="c5"><span class="c0">Proteinase K</span></p> </td> <td class="c6" colspan="1" rowspan="1"> <p class="c5"><span class="c26">P8107S</span></p> </td> </tr> <tr class="c18"> <td class="c10" colspan="1" rowspan="1"> <p class="c5"><span class="c0">AmericanBio</span></p> </td> <td class="c8" colspan="1" rowspan="1"> <p class="c5"><span class="c0">Proteinase K</span></p> </td> <td class="c6" colspan="1" rowspan="1"> <p class="c5"><span class="c26">AB00925</span></p> </td> </tr> <tr class="c11"> <td class="c7" colspan="1" rowspan="16"> <p class="c5"><span class="c0">RT-qPCR Kit</span></p> </td> <td class="c10" colspan="1" rowspan="8"> <p class="c2"><span class="c0">New England Biolabs</span></p> </td> <td class="c8" colspan="1" rowspan="4"> <p class="c2 c29"><span class="c0">Luna Universal Probe One-Step RT qPCR (2x) Kit</span></p> </td> <td class="c6" colspan="1" rowspan="4"> <p class="c5"><span class="c26">E3006S, E3006L, E3006X, E3006E</span></p> </td> </tr> <tr class="c11"></tr> <tr class="c11"></tr> <tr class="c19"></tr> <tr class="c11"> <td class="c8" colspan="1" rowspan="4"> <p class="c2 c9"><span class="c0">Luna Probe One-Step RT-qPCR 4x Mix with UDG</span></p> </td> <td class="c6" colspan="1" rowspan="4"> <p class="c2"><span>M3019S, M3019L, M3019X, M3019E</span></p> </td> </tr> <tr class="c11"></tr> <tr class="c11"></tr> <tr class="c19"></tr> <tr class="c11"> <td class="c10" colspan="1" rowspan="3"> <p class="c25"><span class="c0">Bio-Rad</span></p> </td> <td class="c8" colspan="1" rowspan="3"> <p class="c2 c23"><span class="c0">Reliance One-Step Multiplex RT-qPCR Supermix</span></p> </td> <td class="c6" colspan="1" rowspan="3"> <p class="c2"><span>12010176, 12010220, 12010221</span></p> </td> </tr> <tr class="c11"></tr> <tr class="c11"></tr> <tr class="c11"> <td class="c10" colspan="1" rowspan="3"> <p class="c2"><span class="c0">Quantabio</span></p> </td> <td class="c8" colspan="1" rowspan="3"> <p class="c2"><span class="c0">UltraPlex 1-Step ToughMix</span></p> </td> <td class="c6" colspan="1" rowspan="3"> <p class="c5"><span class="c0">95166-100, 95166-500, 95166-01K</span></p> </td> </tr> <tr class="c11"></tr> <tr class="c11"></tr> <tr class="c11"> <td class="c10" colspan="1" rowspan="2"> <p class="c2"><span class="c0">ThermoFisher Scientific</span></p> </td> <td class="c8" colspan="1" rowspan="2"> <p class="c2 c20"><span class="c0">TaqPath 1-Step RT-qPCR Master Mix, GC</span></p> </td> <td class="c6" colspan="1" rowspan="2"> <p class="c5"><span class="c0">A15299, A15300</span></p> </td> </tr> <tr class="c11"></tr> <tr class="c11"> <td class="c7" colspan="1" rowspan="16"> <p class="c2"><span class="c0">Primer/Probes</span></p> </td> <td class="c10" colspan="1" rowspan="1"> <p class="c2"><span class="c0">Eurofins Genomics</span></p> </td> <td class="c8" colspan="1" rowspan="1"> <p class="c2 c30"><span class="c0">SalivaDirect™ primer and probe set</span></p> </td> <td class="c6" colspan="1" rowspan="1"> <p class="c2"><span>12YS-010YST (Cy5), 12YS-010YS3 (HEX), 12YS-010YS2 (FAM)</span></p> </td> </tr> <tr class="c11"> <td class="c10" colspan="1" rowspan="1"> <p class="c2"><span class="c0">Lighthouse Lab Services</span></p> </td> <td class="c8" colspan="1" rowspan="1"> <p class="c2"><span class="c0">SalivaNow SARS-CoV-2 Assay (primers/probes pre-mixed)</span></p> </td> <td class="c6" colspan="1" rowspan="1"> <p class="c2"><span class="c0">9731816-S</span></p> </td> </tr> <tr class="c18"> <td class="c10" colspan="1" rowspan="14"> <p class="c2 c35"><span class="c0">Integrated DNA Technologies</span></p> </td> <td class="c8" colspan="1" rowspan="2"> <p class="c2"><span class="c0">nCOV_N1 Forward Primer </span></p> </td> <td class="c6" colspan="1" rowspan="2"> <p class="c2"><span class="c0">10006821, 10006830</span></p> </td> </tr> <tr class="c19"></tr> <tr class="c18"> <td class="c8" colspan="1" rowspan="2"> <p class="c2"><span class="c0">nCOV_N1 Reverse Primer </span></p> </td> <td class="c6" colspan="1" rowspan="2"> <p class="c2"><span class="c0">10006822, 10006831</span></p> </td> </tr> <tr class="c19"></tr> <tr class="c18"> <td class="c8" colspan="1" rowspan="2"> <p class="c2"><span class="c0">nCOV_N1 Probe </span></p> </td> <td class="c6" colspan="1" rowspan="2"> <p class="c2"><span class="c0">10006823, 10006832</span></p> </td> </tr> <tr class="c19"></tr> <tr class="c32"> <td class="c8" colspan="1" rowspan="2"> <p class="c2"><span class="c0">RNase P Forward Primer </span></p> </td> <td class="c6" colspan="1" rowspan="2"> <p class="c2"><span class="c0">10006827, 10006836</span></p> </td> </tr> <tr class="c19"></tr> <tr class="c18"> <td class="c8" colspan="1" rowspan="2"> <p class="c2"><span class="c0">RNase P Reverse Primer </span></p> </td> <td class="c6" colspan="1" rowspan="2"> <p class="c2"><span class="c0">10006828, 10006837</span></p> </td> </tr> <tr class="c19"></tr> <tr class="c18"> <td class="c8" colspan="1" rowspan="4"> <p class="c2"><span class="c0">RNase P Probe</span></p> </td> <td class="c6" colspan="1" rowspan="4"> <p class="c2"><span class="c0">Custom order (Cy5)</span></p> <p class="c2"><span class="c0">10007061, 10007062 (ATTO647)</span></p> </td> </tr> <tr class="c18"></tr> <tr class="c18"></tr> <tr class="c19"></tr> <tr class="c19"> <td class="c7" colspan="1" rowspan="2"> <p class="c2"><span>Nuclease-free water</span></p> </td> <td class="c10" colspan="1" rowspan="1"> <p class="c2 c35"><span class="c0">Integrated DNA Technologies</span></p> </td> <td class="c8" colspan="1" rowspan="1"> <p class="c2"><span class="c0">Nuclease-free water</span></p> </td> <td class="c6" colspan="1" rowspan="1"> <p class="c2"><span class="c0">11-04-02-01, 11-05-01-14, 11-05-01-04</span></p> </td> </tr> <tr class="c18"> <td class="c10" colspan="1" rowspan="1"> <p class="c2"><span class="c0">New England Biolabs</span></p> </td> <td class="c8" colspan="1" rowspan="1"> <p class="c2"><span class="c0">Nuclease-free water</span></p> </td> <td class="c6" colspan="1" rowspan="1"> <p class="c2"><span class="c0">B1500S, B1500L</span></p> </td> </tr> <tr class="c18"> <td class="c7" colspan="1" rowspan="3"> <p class="c5"><span class="c0">Controls</span></p> </td> <td class="c10" colspan="1" rowspan="1"> <p class="c2"><span class="c0">Twist Bioscience</span></p> </td> <td class="c8" colspan="1" rowspan="1"> <p class="c2"><span class="c0">Synthetic SARS-CoV-2 RNA Control 2</span></p> </td> <td class="c6" colspan="1" rowspan="1"> <p class="c2"><span class="c0">102024</span></p> </td> </tr> <tr class="c18"> <td class="c10" colspan="1" rowspan="2"> <p class="c2"><span class="c0">Lighthouse Lab</span></p> <p class="c2"><span class="c0">Services</span></p> </td> <td class="c8" colspan="1" rowspan="1"> <p class="c2"><span class="c0">Positive CoV-2 Control</span></p> </td> <td class="c6" colspan="1" rowspan="1"> <p class="c2"><span class="c0">9731816PC</span></p> </td> </tr> <tr class="c18"> <td class="c8" colspan="1" rowspan="1"> <p class="c2"><span class="c0">Negative Control</span></p> </td> <td class="c6" colspan="1" rowspan="1"> <p class="c2"><span class="c0">9731816EC</span></p> </td> </tr> </table> </div> </div> <div class="elementor-element elementor-element-bed977d elementor-widget elementor-widget-text-editor" data-id="bed977d" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p><span style="font-weight: 400;">For a more comprehensive list of all reagents and instruments, review the </span><a href="http://fda.gov"><span style="font-weight: 400;">full EUA, available at FDA.gov</span></a><span style="font-weight: 400;">.</span></p><p><b>Instruments</b></p> </div> </div> <div class="elementor-element elementor-element-1293a55 elementor-widget elementor-widget-html" data-id="1293a55" data-element_type="widget" data-widget_type="html.default"> <div class="elementor-widget-container"> <table class="c27"> <tr class="c19"> <td class="c1" colspan="1" rowspan="1"> <p class="c5"><span class="c13 c3"><b>Vendor</b></span></p> </td> <td class="c16" colspan="1" rowspan="1"> <p class="c5"><span class="c13 c3"><b>Model(s)</b></span></p> </td> </tr> <tr class="c18"> <td class="c1" colspan="1" rowspan="1"> <p class="c5"><span class="c0">Bio-Rad </span></p> </td> <td class="c16" colspan="1" rowspan="1"> <p class="c5"><span class="c0">CFX96 Touch, CFX384 Touch, CFX Opus Real-Time PCR Detection System</span> </p> </td> </tr> <tr class="c18"> <td class="c1" colspan="1" rowspan="1"> <p class="c5"><span class="c0">ThermoFisher</span></p> </td> <td class="c16" colspan="1" rowspan="1"> <p class="c5"><span class="c26">ABI StepOne/StepOne Plus<br>ABI 7500 Fast/Fast Dx, ABI PRISM 7000, ABI ViiA 7, ABI QuantStudio 3, QuantStudio 5, QuantStudio 6, QuantStudio 7 Pro/Flex, QuantStudio 12K Flex, QuantStudio Dx  Real-Time PCR System</span></p> </td> </tr> <tr class="c18"> <td class="c1" colspan="1" rowspan="1"> <p class="c5"><span class="c0">Agilent</span></p> </td> <td class="c16" colspan="1" rowspan="1"> <p class="c5"><span class="c0">AriaMX Real-Time PCR System</span></p> </td> </tr> <tr class="c18"> <td class="c1" colspan="1" rowspan="1"> <p class="c5"><span class="c0">Ubiquitome</span></p> </td> <td class="c16" colspan="1" rowspan="1"> <p class="c5"><span class="c0">Liberty 16, Liberty 16 Pro</span></p> </td> </tr> <tr class="c18"> <td class="c1" colspan="1" rowspan="1"> <p class="c5"><span class="c0">Analytik Jena</span></p> </td> <td class="c16" colspan="1" rowspan="1"> <p class="c5"><span class="c0">qTower</span></p> </td> </tr> <tr class="c18"> <td class="c1" colspan="1" rowspan="1"> <p class="c5"><span class="c0">Roche</span></p> </td> <td class="c16" colspan="1" rowspan="1"> <p class="c5"><span class="c0">Cobas Z480, LightCycler 480</span></p> </td> </tr> <tr class="c18"> <td class="c1" colspan="1" rowspan="1"> <p class="c5"><span class="c0">CHAI</span></p> </td> <td class="c16" colspan="1" rowspan="1"> <p class="c5"><span class="c0">Open qPCR</span></p> </td> </tr> <tr class="c18"> <td class="c1" colspan="1" rowspan="1"> <p class="c5"><span class="c0">Bio Molecular Systems</span></p> </td> <td class="c16" colspan="1" rowspan="1"> <p class="c5"><span class="c0">Mic, Mic qPCR/Q</span></p> </td> </tr> <tr class="c18"> <td class="c1" colspan="1" rowspan="1"> <p class="c5"><span class="c0">OnsiteGene</span></p> </td> <td class="c16" colspan="1" rowspan="1"> <p class="c5"><span class="c0">XDiveTM Superfast Real-Time PCR System</span></p> </td> </tr> </table> </div> </div> <div class="elementor-element elementor-element-420b543 elementor-widget elementor-widget-text-editor" data-id="420b543" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p><span style="font-weight: 400;">For a more comprehensive list of all instruments and validated software versions, review the </span><a href="http://fda.gov"><span style="font-weight: 400;">full EUA, available at FDA.gov</span></a><span style="font-weight: 400;">.</span></p><p><b>Workflows</b></p><p><span style="font-weight: 400;">The SalivaDirect™ protocol has been validated for use in three different nucleic acid extraction-free sample preparation workflows. See the image below:</span></p> </div> </div> <div class="elementor-element elementor-element-cf42223 elementor-widget elementor-widget-image" data-id="cf42223" data-element_type="widget" data-widget_type="image.default"> <div class="elementor-widget-container"> <img loading="lazy" decoding="async" width="800" height="467" src="https://salivadirectinc.org/wp-content/uploads/2024/11/image1-1-1024x598.png" class="attachment-large size-large wp-image-725" alt="The three different nucleic acid extraction-free sample preparation workflows. 1. Raw saliva, heat pretreatment, Targets: N1 + RP (Dualplex RT-qPCR) 2. Raw saliva, proteinase K, combine and mix, heat inactivate, Targets: N1 + RP (Dualplex RT-qPCR) 3. Raw saliva, heat pretreatment (65 degrees celsius for 15 mins, 95 degrees celsius for 30 mins), proteinase K, combine and mix, heat inactivate, Targets: N1 + RP (Dualplex RT-qPCR)." srcset="https://salivadirectinc.org/wp-content/uploads/2024/11/image1-1-1024x598.png 1024w, https://salivadirectinc.org/wp-content/uploads/2024/11/image1-1-300x175.png 300w, https://salivadirectinc.org/wp-content/uploads/2024/11/image1-1-768x448.png 768w, https://salivadirectinc.org/wp-content/uploads/2024/11/image1-1-1536x897.png 1536w, https://salivadirectinc.org/wp-content/uploads/2024/11/image1-1.png 1999w" sizes="(max-width: 800px) 100vw, 800px" /> </div> </div> <div class="elementor-element elementor-element-3104985 elementor-widget elementor-widget-text-editor" data-id="3104985" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p><span style="font-weight: 400;">SalivaDirect, Inc. is actively working toward obtaining FDA </span><i><span style="font-weight: 400;">De Novo</span></i><span style="font-weight: 400;"> approval for the SalivaDirect™ SARS-CoV-2 assay. The protocol will initially include a single workflow using Proteinase K and focus on the following reagents and instruments:</span></p> </div> </div> <div class="elementor-element elementor-element-b51ba59 elementor-widget elementor-widget-html" data-id="b51ba59" data-element_type="widget" data-widget_type="html.default"> <div class="elementor-widget-container"> <table class="c27"> <tr class="c19"> <td class="c12" colspan="1" rowspan="1"> <p class="c5"><span class="c13 c3"><b>Reagent</b></span></p> </td> <td class="c10" colspan="1" rowspan="1"> <p class="c5"><span class="c13 c3"><b>Vendor</b></span></p> </td> <td class="c8" colspan="1" rowspan="1"> <p class="c5"><span class="c13 c3"><b>Item</b></span></p> </td> <td class="c6" colspan="1" rowspan="1"> <p class="c5"><span class="c13 c3"><b>Catalog Number(s)</b></span></p> </td> </tr> <tr class="c31"> <td class="c12" colspan="1" rowspan="1"> <p class="c5"><span class="c0">Proteinase K</span></p> </td> <td class="c10" colspan="1" rowspan="1"> <p class="c5"><span class="c0">ThermoFisher Scientific</span></p> </td> <td class="c8" colspan="1" rowspan="1"> <p class="c5"><span class="c0">MagMAX Viral/Pathogen Proteinase K</span></p> </td> <td class="c6" colspan="1" rowspan="1"> <p class="c5"><span class="c26">A42363</span></p> </td> </tr> <tr class="c11"> <td class="c12" colspan="1" rowspan="1"> <p class="c5"><span class="c0">RT-qPCR Kit</span></p> </td> <td class="c10" colspan="1" rowspan="1"> <p class="c2"><span class="c0">New England Biolabs</span></p> </td> <td class="c8" colspan="1" rowspan="1"> <p class="c2 c9"><span class="c0">Luna Probe One-Step RT-qPCR 4x Mix with UDG</span></p> </td> <td class="c6" colspan="1" rowspan="1"> <p class="c2"><span>M3019S, M3019L, M3019X, M3019E</span></p> </td> </tr> <tr class="c18"> <td class="c12" colspan="1" rowspan="14"> <p class="c2"><span>Primer/Probes</span></p> </td> <td class="c10" colspan="1" rowspan="14"> <p class="c2 c35"><span>Integrated DNA Technologies</span></p> </td> <td class="c8" colspan="1" rowspan="2"> <p class="c2"><span class="c0">nCOV_N1 Forward Primer </span></p> </td> <td class="c6" colspan="1" rowspan="2"> <p class="c2"><span class="c0">10006821, 10006830</span></p> </td> </tr> <tr class="c11"></tr> <tr class="c18"> <td class="c8" colspan="1" rowspan="2"> <p class="c2"><span class="c0">nCOV_N1 Reverse Primer </span></p> </td> <td class="c6" colspan="1" rowspan="2"> <p class="c2"><span class="c0">10006822, 10006831</span></p> </td> </tr> <tr class="c11"></tr> <tr class="c18"> <td class="c8" colspan="1" rowspan="2"> <p class="c2"><span class="c0">nCOV_N1 Probe </span></p> </td> <td class="c6" colspan="1" rowspan="2"> <p class="c2"><span class="c0">10006823, 10006832</span></p> </td> </tr> <tr class="c11"></tr> <tr class="c32"> <td class="c8" colspan="1" rowspan="2"> <p class="c2"><span class="c0">RNase P Forward Primer </span></p> </td> <td class="c6" colspan="1" rowspan="2"> <p class="c2"><span class="c0">10006827, 10006836</span></p> </td> </tr> <tr class="c11"></tr> <tr class="c18"> <td class="c8" colspan="1" rowspan="2"> <p class="c2"><span class="c0">RNase P Reverse Primer </span></p> </td> <td class="c6" colspan="1" rowspan="2"> <p class="c2"><span class="c0">10006828, 10006837</span></p> </td> </tr> <tr class="c11"></tr> <tr class="c18"> <td class="c8" colspan="1" rowspan="4"> <p class="c2"><span class="c0">RNase P Probe</span></p> </td> <td class="c6" colspan="1" rowspan="4"> <p class="c2"><span class="c0">Custom order (Cy5)</span></p> <p class="c2"><span class="c0">10007061, 10007062 (ATTO647)</span></p> </td> </tr> <tr class="c18"></tr> <tr class="c18"></tr> <tr class="c11"></tr> <tr class="c19"> <td class="c12" colspan="1" rowspan="1"> <p class="c2"><span>Nuclease-free water</span></p> </td> <td class="c10" colspan="1" rowspan="1"> <p class="c2"><span>New England Biolabs</span></p> </td> <td class="c8" colspan="1" rowspan="1"> <p class="c2"><span>Nuclease-free water</span></p> </td> <td class="c6" colspan="1" rowspan="1"> <p class="c2"><span class="c0">B1500S, B1500L</span></p> </td> </tr> <tr class="c18"> <td class="c12" colspan="1" rowspan="1"> <p class="c5"><span class="c0">Controls</span></p> </td> <td class="c10" colspan="1" rowspan="1"> <p class="c2"><span class="c0">Twist Bioscience</span></p> </td> <td class="c8" colspan="1" rowspan="1"> <p class="c2"><span class="c0">Synthetic SARS-CoV-2 RNA Control 2</span></p> </td> <td class="c6" colspan="1" rowspan="1"> <p class="c2"><span class="c0">102024</span></p> </td> </tr> </table> </div> </div> <div class="elementor-element elementor-element-05f9ea4 elementor-widget elementor-widget-html" data-id="05f9ea4" data-element_type="widget" data-widget_type="html.default"> <div class="elementor-widget-container"> <table class="c27"> <tr class="c19"> <td class="c1" colspan="1" rowspan="1"> <p class="c5"><span class="c13 c3"><b>Vendor</b></span></p> </td> <td class="c16" colspan="1" rowspan="1"> <p class="c5"><span class="c3 c13"><b>Model(s)</b></span></p> </td> </tr> <tr class="c18"> <td class="c1" colspan="1" rowspan="1"> <p class="c5"><span class="c0">Bio-Rad </span></p> </td> <td class="c16" colspan="1" rowspan="1"> <p class="c5"><span>CFX96 Touch Real-Time PCR Detection System</span></p> </td> </tr> <tr class="c18"> <td class="c1" colspan="1" rowspan="1"> <p class="c5"><span class="c0">ThermoFisher</span></p> </td> <td class="c16" colspan="1" rowspan="1"> <p class="c5"><span class="c26">ABI </span><span class="c26">QuantStudio 6</span><span class="c26"> Pro Real-Time PCR System<br>ABI </span><span class="c26">QuantStudio 7</span><span class="c26"> Pro Real-Time PCR System</span></p> </td> </tr> </table> </div> </div> <div class="elementor-element elementor-element-30af106 elementor-widget elementor-widget-heading" data-id="30af106" data-element_type="widget" id="in-development" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h2 class="elementor-heading-title elementor-size-default"><h2>In Development: SalivaDirect+™</h2></h2> </div> </div> <div class="elementor-element elementor-element-765b0f3 elementor-widget elementor-widget-text-editor" data-id="765b0f3" data-element_type="widget" id="salivaDirectplus" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p><span style="font-weight: 400;">While the SalivaDirect™ protocol focuses exclusively on detecting SARS-CoV-2, SalivaDirect+<span style="color: #001d35; font-family: 'Google Sans', Roboto, Arial, sans-serif; font-size: var( --e-global-typography-text-font-size ); font-weight: var( --e-global-typography-text-font-weight ); text-align: var(--text-align);">™</span> is in development. Utilizing the SalivaDirect<span style="color: #001d35; font-family: 'Google Sans', Roboto, Arial, sans-serif; font-size: var( --e-global-typography-text-font-size ); font-weight: var( --e-global-typography-text-font-weight ); text-align: var(--text-align);">™</span> extraction-free protocol, SalivaDirect+<span style="color: #001d35; font-family: 'Google Sans', Roboto, Arial, sans-serif; font-size: var( --e-global-typography-text-font-size ); font-weight: var( --e-global-typography-text-font-weight ); text-align: var(--text-align);">™</span> will be able to detect SARS-CoV-2, Influenza A, Influenza B, and Respiratory Syncytial Virus (RSV) in a single saliva sample. By combining the detection of multiple viruses, SalivaDirect+<span style="color: #001d35; font-family: 'Google Sans', Roboto, Arial, sans-serif; font-size: var( --e-global-typography-text-font-size ); font-weight: var( --e-global-typography-text-font-weight ); text-align: var(--text-align);">™</span> will provide a more comprehensive tool for diagnosing and differentiating between various respiratory infections – ensuring providers and patients are empowered with comprehensive health information, reducing the use of inappropriate antibiotic treatment, and improving infectious disease surveillance data for public health agencies.</span></p><p><span style="color: var( --e-global-color-text ); font-family: var( --e-global-typography-text-font-family ), Sans-serif; font-size: var( --e-global-typography-text-font-size ); text-align: var(--text-align);"><span style="font-weight: 400;"><strong>SalivaDirect, Inc. is currently conducting a prospective clinical validation study for the SalivaDirect+™ protocol</strong>. If you or your laboratory are interested in joining the study and supporting our assay development work, contact us at </span></span><a style="font-family: var( --e-global-typography-text-font-family ), Sans-serif; font-size: var( --e-global-typography-text-font-size ); font-weight: var( --e-global-typography-text-font-weight ); text-align: var(--text-align); background-color: #ffffff;" href="/cdn-cgi/l/email-protection#ccafa0a5a2a5afada08cbfada0a5baada8a5bea9afb8a5a2afe2a3beab"><span class="__cf_email__" data-cfemail="0e6d626760676d6f624e7d6f6267786f6a677c6b6d7a67606d20617c69">[email protected]</span></a><span style="color: var( --e-global-color-text ); font-family: var( --e-global-typography-text-font-family ), Sans-serif; font-size: var( --e-global-typography-text-font-size ); text-align: var(--text-align);"><span style="font-weight: 400;">. </span></span></p> </div> </div> </div> </div> </div> <div class="elementor-element elementor-element-40fc5ef e-flex e-con-boxed e-con e-parent" data-id="40fc5ef" data-element_type="container" id="publications"> <div class="e-con-inner"> <div class="elementor-element elementor-element-4e02c28 elementor-widget__width-initial elementor-widget elementor-widget-heading" data-id="4e02c28" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h2 class="elementor-heading-title elementor-size-default"><H2>SalivaDirect, Inc. Publications</h2></h2> </div> </div> </div> </div> <div class="elementor-element elementor-element-dde1679 e-flex e-con-boxed e-con e-parent" data-id="dde1679" data-element_type="container"> <div class="e-con-inner"> <div class="elementor-element elementor-element-a5a8431 e-con-full e-flex e-con e-child" data-id="a5a8431" data-element_type="container"> <div class="elementor-element elementor-element-6fdb3c4 elementor-widget elementor-widget-text-editor" data-id="6fdb3c4" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <h3>2024</h3><ul><li style="font-weight: 400;" aria-level="1"><a href="https://www.medrxiv.org/content/10.1101/2024.01.03.24300789v1"><span style="font-weight: 400;">Contact with young children is a major risk factor for pneumococcal colonization in older adults (Wyllie et al., 2024)</span></a></li><li style="font-weight: 400;" aria-level="1"><a href="https://www.medrxiv.org/content/10.1101/2024.07.19.24309369v1"><span style="font-weight: 400;">Detection of pneumococcal carriage in asymptomatic healthcare workers (Waghela, et al., 2024)</span></a></li><li><a href="https://pubmed.ncbi.nlm.nih.gov/39078819/"><span style="font-weight: 400;">Diagnostic testing preferences can help inform future public health response efforts: Global insights from an international survey (Salzano et al., 2024)</span></a></li><li style="font-weight: 400;" aria-level="1"><a href="https://www.medrxiv.org/content/10.1101/2024.11.21.24317748v1"><span style="font-weight: 400;">Mobilizing community-driven public health response: increasing access to diagnostic testing for underserved and uninsured individuals in Connecticut through lab-in-a-van partnerships </span></a><a href="https://www.medrxiv.org/content/10.1101/2024.11.21.24317748v1"><span style="font-weight: 400;">(Choate et al., 2024)</span></a></li><li style="font-weight: 400;" aria-level="1"><a href="https://www.frontiersin.org/journals/cellular-and-infection-microbiology/articles/10.3389/fcimb.2024.1446514/full"><span style="font-weight: 400;">Scalable solutions for global health: the SalivaDirect model (Wyllie et al., 2024)</span></a></li></ul><h3> </h3><h3>2023</h3><ul><li style="font-weight: 400;" aria-level="1"><a href="https://www.medrxiv.org/content/10.1101/2023.12.07.23299679v2"><span style="font-weight: 400;">A low-cost culture- and DNA extraction-free method for the molecular detection of pneumococcal carriage in saliva (Peno et al., 2023)</span></a></li><li style="font-weight: 400;" aria-level="1"><a href="https://www.medrxiv.org/content/10.1101/2023.06.12.23291295v2"><span style="font-weight: 400;">Expansion of a low-cost, saliva-based PCR test for the detection of mpox virus (Thomas et al., 2023)</span></a></li><li style="font-weight: 400;" aria-level="1"><a href="https://www.medrxiv.org/content/10.1101/2023.10.04.23296240v1"><span style="font-weight: 400;">Exploring the potential of a saliva-based, RNA-extraction-free PCR test for the multiplexed detection of key respiratory pathogens (Allicock et al., 2023)</span></a></li><li style="font-weight: 400;" aria-level="1"><a href="https://pubmed.ncbi.nlm.nih.gov/37369293/"><span style="font-weight: 400;">Method versatility in RNA extraction-free PCR detection of SARS-CoV-2 in saliva samples (Allicock et al., 2023)</span></a></li><li style="font-weight: 400;" aria-level="1"><a href="https://www.nature.com/articles/s41598-023-34662-2"><span style="font-weight: 400;">Pooled RNA-extraction-free testing of saliva for the detection of SARS-CoV-2 (Allicock et al., 2023)</span></a></li><li style="font-weight: 400;" aria-level="1"><a href="https://www.thelancet.com/journals/lanmic/article/PIIS2666-5247(23)00135-0/fulltext"><span style="font-weight: 400;">The potential of saliva as an accessible and sensitive sample type for the detection of respiratory pathogens and host immunity (Laxton et. al, 2023)</span></a></li></ul><h3> </h3><h3>2022</h3><ul><li style="font-weight: 400;" aria-level="1"><a href="https://www.medrxiv.org/content/10.1101/2022.02.09.22270653v1"><span style="font-weight: 400;">COVID Testing in the Workplace: Return to Work Testing in an Occupational Cohort </span></a><a href="https://www.medrxiv.org/content/10.1101/2022.01.04.22268770v1"><span style="font-weight: 400;">(Sikka et al., 2022)</span></a></li><li style="font-weight: 400;" aria-level="1"><a href="https://www.medrxiv.org/content/10.1101/2022.01.04.22268770v1"><span style="font-weight: 400;">Discordant SARS-CoV-2 PCR and Rapid Antigen Test Results When Infectious: A December 2021 Occupational Case Series (Sikka et al., 2022)</span></a></li><li style="font-weight: 400;" aria-level="1"><a href="https://www.medrxiv.org/content/10.1101/2022.01.04.22268770v1"><span style="font-weight: 400;">Evaluation of saliva self-collection devices for SARS-CoV-2 diagnostics (Allicock et al., 2022)</span></a></li><li style="font-weight: 400;" aria-level="1"><a href="https://www.medrxiv.org/content/10.1101/2022.06.28.22276654v1"><span style="font-weight: 400;">Persistence of pneumococcal carriage among older adults in the community despite COVID-19 mitigation measures (Wyllie et al., 2022)</span></a></li><li style="font-weight: 400;" aria-level="1"><a href="https://www.medrxiv.org/content/10.1101/2022.05.05.22274434v1"><span style="font-weight: 400;">Routine Saliva Testing for SARS-CoV-2 in Children: Partnering with Childcare Centers in the Greater New Haven Community (Rayack et al., 2022)</span></a></li><li style="font-weight: 400;" aria-level="1"><a href="https://pubmed.ncbi.nlm.nih.gov/35763281/"><span style="font-weight: 400;">Saliva as a sample type for SARS-CoV-2 detection: implementation successes and opportunities around the globe (Tobik et al., 2022)</span></a></li><li style="font-weight: 400;" aria-level="1"><a href="https://www.medrxiv.org/content/10.1101/2022.01.04.22268770v1"><span style="font-weight: 400;">Saliva-based methods for SARS-CoV-2 testing in low- and middle-income countries (Tan et al., 2022)</span></a></li></ul><h3> </h3><h3>2021</h3><ul><li style="font-weight: 400;" aria-level="1"><a href="https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(21)00178-8/fulltext"><span style="font-weight: 400;">Saliva as a gold-standard sample for SARS-CoV-2 detection (Tan et al., 2021</span></a><a href="https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(21)00178-8/fulltext"><span style="font-weight: 400;">)</span></a></li><li style="font-weight: 400;" aria-level="1"><a href="https://www.medrxiv.org/content/10.1101/2021.06.21.21259289v1"><span style="font-weight: 400;">Sequencing SARS-CoV-2 Genomes from Saliva</span></a><a href="https://www.medrxiv.org/content/10.1101/2021.06.21.21259289v1"><span style="font-weight: 400;"> (</span><span style="font-weight: 400;">Alpert</span><span style="font-weight: 400;"> et al., 2021)</span></a></li><li><a href="https://wwwnc.cdc.gov/eid/article/27/4/20-4199_article"><span style="font-weight: 400;">Stability of SARS-CoV-2 RNA in Non Supplemented Saliva</span></a><a href="https://wwwnc.cdc.gov/eid/article/27/4/20-4199_article"><span style="font-weight: 400;"> (Ott et al., 2021)</span></a></li></ul><h3> </h3><h3>2020</h3><ul><li style="font-weight: 400;" aria-level="1"><a href="https://www.medrxiv.org/content/10.1101/2020.08.03.20167791v2"><span style="font-weight: 400;">SalivaDirect: A simplified and flexible platform to enhance SARS-CoV-2 testing capacity</span></a><a href="https://www.medrxiv.org/content/10.1101/2020.08.03.20167791v2"><span style="font-weight: 400;"> (Vogels et al, 2020)</span></a></li><li><a href="https://pubmed.ncbi.nlm.nih.gov/32857487/"><span style="font-weight: 400;">Saliva or Nasopharyngeal Swab Specimens for Detection of SARS-CoV-2 </span></a><a href="https://pubmed.ncbi.nlm.nih.gov/32857487/"><span style="font-weight: 400;">(Wyllie et al., 2020)</span></a></li></ul> </div> </div> </div> </div> </div> <div class="elementor-element elementor-element-ae6e85c e-flex e-con-boxed e-con e-parent" data-id="ae6e85c" data-element_type="container" id="international-validation"> <div class="e-con-inner"> <div class="elementor-element elementor-element-e3cc0b1 elementor-widget elementor-widget-heading" data-id="e3cc0b1" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h2 class="elementor-heading-title elementor-size-default"><H2>International Validation</h2></h2> </div> </div> <div class="elementor-element elementor-element-9d1991a e-con-full e-flex e-con e-child" data-id="9d1991a" data-element_type="container"> <div class="elementor-element elementor-element-8877a16 elementor-widget elementor-widget-html" data-id="8877a16" data-element_type="widget" data-widget_type="html.default"> <div class="elementor-widget-container"> <table> <tr> <td>Australia</td> <td> <ul> <li> <a href="https://www.sciencedirect.com/science/article/pii/S0031302521004311"> Use of emerging testing technologies and approaches for SARS-CoV-2: review of literature and global experience in an Australian context (Graham et al., 2021) </a> </li> <li> <a href="https://www.mja.com.au/journal/2021/addition-saliva-oropharyngeal-and-deep-nasal-swabs-increases-pcr-detection-sars-cov-2"> Addition of saliva to oropharyngeal and deep nasal swabs increases PCR detection of SARS-CoV-2 in pediatric and primary care settings, Victoria, Australia July–October 2020 (Oliver et al., 2021) </a> </li> </ul> </td> </tr> <tr> <td>Bahamas</td> <td> <ul> <li> <a href="https://www.medrxiv.org/content/10.1101/2024.10.10.24314969v1"> Performance of and preference for saliva sampling for detection of SARS-COV-2 in the Bahamas (Martin et al., 2024) </a> </li> </ul> </td> </tr> <tr> <td>Bangladesh</td> <td> <ul> <li> <a href="https://acrobat.adobe.com/link/review?uri=urn%3Aaaid%3Ascds%3AUS%3A2bae4953-37e2-3ebc-acf6-c4e69d1890d9"> SalivaDirect: an alternative to a conventional RNA extraction protocol for molecular detection of SARS-CoV-2 in a clinical setting (Mafij Uddin et al., 2023) </a> </li> </ul> </td> </tr> <tr> <td>Brazil</td> <td> <ul> <li> <a href="https://www.sciencedirect.com/science/article/pii/S0166093421001804?via%3Dihub"> SARS-CoV-2 saliva testing is a useful tool for Covid-19 diagnosis (Mendes de Oliveira et al., 2021) </a> </li> <li> <a href="https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0287814"> Antigen concentration, viral load, and test performance for SARS-CoV-2 in multiple specimen types (Golden et al., 2023) </a> </li> </ul> </td> </tr> <tr> <td>Canada</td> <td> <ul> <li> <a href="https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2775397"> Comparison of Saliva and Nasopharyngeal Swab Nucleic Acid Amplification Testing for Detection of SARS-CoV-2: A Systematic Review and Meta-analysis (Butler-Laporte et al., 2021) </a> </li> </ul> </td> </tr> <tr> <td>Colombia</td> <td> <ul> <li> <a href="https://www.researchgate.net/publication/366599117_Saliva-direct_approach_in_the_detection_of_SARS-CoV-2_in_the_lower-risk_population_in_Colombia"> Saliva‐direct approach in the detection of SARS‐CoV‐2 in the lower‐risk population in Colombia (Corredor et al., 2022) </a> </li> </ul> </td> </tr> <tr> <td>India</td> <td> <ul> <li> <a href="https://www.medrxiv.org/content/10.1101/2022.02.07.22269889v1"> Validating saliva as a biological sample for cost-effective, rapid and routine screening for SARS-CoV-2 (Ansil et al., 2022) </a> </li> </ul> </td> </tr> <tr> <td>Ireland</td> <td> <ul> <li> <a href="https://doi.org/10.5061/dryad.ksn02v74n"> Concordance between PCR-based extraction-free saliva and nasopharyngeal swabs for SARS-CoV-2 testing (De Santi et al., 2021) </a> </li> </ul> </td> </tr> <tr> <td>Italy</td> <td> <ul> <li> <a href="https://pmc.ncbi.nlm.nih.gov/articles/PMC8304905/"> Saliva Molecular Testing for SARS-CoV-2 Surveillance in Two Italian Primary Schools (Carmagnola et al., 2021) </a> </li> </ul> </td> </tr> <tr> <td>Malawi</td> <td> <ul> <li> <a href="https://drive.google.com/file/d/1pOVe7grA4tENiGT_Ewasm7d7d5c7QP6i/view?usp=drive_link"> Implementation of a low-cost saliva-based diagnostic assay for the detection of SARS-CoV-2 (SalivaDirect) and other key respiratory viruses in Malawi; a low-income setting (Mlongoti et al., 2024) </a> </li> </ul> </td> </tr> <tr> <td>Mexico</td> <td> <ul> <li> <a href="https://www.bmhim.com/frame_esp.php?id=173"> Saliva as a promising biofluid for SARS-CoV-2 detection during the early stages of infection (López-Martínez et al., 2020) </a> </li> <li> <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8040950/"> Comparison Between a Standard and SalivaDirect RNA Extraction Protocol for Molecular Diagnosis of SARS-CoV-2 Using Nasopharyngeal Swab and Saliva Clinical Samples (Rodríguez Flores et al., 2021) </a> </li> </ul> </td> </tr> <tr> <td>New Zealand</td> <td> <ul> <li> <a href="https://www.frontiersin.org/articles/10.3389/fcimb.2021.808773/full"> Evaluation of the Liberty16 Mobile Real Time PCR Device for Use With the SalivaDirect Assay for SARS-CoV-2 Testing (Yolda-Carr et al., 2022) </a> </li> </ul> </td> </tr> <tr> <td>Philippines</td> <td> <ul> <li> <a href="https://redcross.org.ph/covid19/saliva-test/"> Saliva RT-PCR Test </a> </li> </ul> </td> </tr> <tr> <td>United Arab Emirates</td> <td> <ul> <li> <a href="https://cdn.mdedge.com/files/s3fs-public/JCOM02805216.PDF"> Feasibility of a Saliva-Based COVID-19 Screening Program in Abu Dhabi Primary Schools (Virji et al., 2021) </a> </li> </ul> </td> </tr> <tr> <td>United States</td> <td> <ul> <li> <a href="https://www.medrxiv.org/content/10.1101/2020.08.03.20167791v2"> SalivaDirect: A simplified and flexible platform to enhance SARS-CoV-2 testing capacity (Vogels et al, 2020) </a> </li> <li> <a href="https://www.fda.gov/media/141192/download"> Yale School of Public Health, Department of Epidemiology of Microbial Diseases SalivaDirect assay EUA Summary </a> </li> </ul> </td> </tr> <tr> <td>US Virgin Islands</td> <td> <ul> <li> <a href="https://www.stcroixlab.com/"> Clinical Laboratory, Inc. </a> </li> </ul> </td> </tr> </table> </div> </div> </div> <div class="elementor-element elementor-element-bdfdc6f elementor-widget elementor-widget-html" data-id="bdfdc6f" data-element_type="widget" data-widget_type="html.default"> <div class="elementor-widget-container"> <style> #international-validation, #publications, #sd-protocol, #laboratory-designation-process, #lab-network, #in-development { scroll-margin-top: 100px; } </style> </div> </div> </div> </div> </div> </div> </main> <div data-elementor-type="footer" data-elementor-id="400" class="elementor elementor-400 elementor-location-footer" data-elementor-post-type="elementor_library"> <div class="elementor-element 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