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วันนี้ (3 ก.ย.) ที่ศูนย์แถลงข่าวสถานการณ์โรคติดเชื้อไวรัสโคโรนา 2019 กระทรวงสาธารณสุข จ.นนทบุรี นพ.สุรโชค ต่างวิวัฒน์ รองเลขาธิการคณะกรรมการอาหารและยา (อย.) พร้อมด้วย ศ.ดร.ฉัตรเฉลิม อิศรางกูร ณ อยุธยา คณบดีคณะเทคนิคการแพทย์ มหาวิทยาลัยมหิดล และ ผศ.นพ.กำธร มาลาธรรม นายกสมาคมโรคติดเชื้อแห่งประเทศไทย แถลงข่าวประสิทธิผลการใช้ชุดตรวจ ATK ด้วยตนเอง (https://www.grabaforum.com/Guestpost/)
นพ.สุรโชค กล่าวว่า ประเทศไทยมีการใช้ชุดตรวจโควิด ATK ด้วยตนเองมากขึ้น นพ.เกียรติภูมิ วงศ์รจิต ปลัดกระทรวงสาธารณสุข จึงตั้งคณะทำงานผู้เชี่ยวชาญผลิตภัณฑ์ชุดตรวจและน้ำยาที่เกี่ยวข้องกับการวินิจฉัยการติดเชื้อก่อโรคโควิด 19 ATK เพื่อให้คำแนะนำในการกำหนดและนโยบายของกระทรวงสาธารณสุข ที่เป็นประโยชน์กับประชาชน สำหรับการขึ้นทะเบียนชุดตรวจ บริษัทผู้ผลิต/นำเข้า ต้องส่งตัวอย่างไปประเมินทดสอบทางคลินิก ก่อนนำข้อมูลมายื่นให้ อย.และสภาเทคนิคการแพทย์ร่วมกันประเมินตามเกณฑ์ที่กำหนดเพื่อออกใบอนุญาต ปัจจุบันมีชุดตรวจโควิดด้วยตนเองขึ้นทะเบียน 45 ราย สังเกตได้จากข้อความระบุว่า คัดกรองเบื้องต้น เมื่อผลิตภัณฑ์ออกสู่ตลาด จะติดตามตรวจสอบคุณภาพ สถานที่เก็บผลิตภัณฑ์ที่เหมาะสม รวมถึงการโฆษณาที่ผิดกฎหมาย หากพบการโฆษณาเกินจริง หรือปัญหาคุณภาพชุดตรวจ ATK สามารถสอบถามหรือแจ้งข้อมูลที่สายด่วน 1556 เพื่อให้อย.ดำเนินการตามกฎหมายต่อไป
ศ.ดร.ฉัตรเฉลิม กล่าวว่า องค์การอนามัยโลกศึกษา พบว่า ปัจจัยที่ส่งผลต่อประสิทธิภาพการตรวจคัดกรองด้วย ATK คือ 1.ระยะเวลาการรับเชื้อ หากตรวจในช่วง 7 วันหลังรับเชื้อและเริ่มมีอาการ จะมีประสิทธิภาพสูงมาก 2.กระบวนการเก็บสิ่งส่งตรวจด้วยตนเองทั้งจากโพรงจมูกหรือน้ำลาย ต้องถูกต้อง โดยศึกษาได้จากคู่มือการใช้งานหรือวิดีโอสาธิต หรือได้รับการฝึกฝนการเก็บตัวอย่าง 3.ปริมาณเชื้อไวรัสในสิ่งส่งตรวจ ยิ่งมีเชื้อมากจะตรวจพบได้ง่าย ถ้าปริมาณน้อยอาจตรวจไม่พบ ทำให้เกิดผลลบปลอมได้ และ 4.คุณภาพน้ำยาในการตรวจ การเก็บรักษาและความคงทนของชุดตรวจ ทั้งนี้ อย.ได้ร่วมกับหน่วยงานต่างๆ กำกับดูแลชุดตรวจก่อนออกสู่ตลาด โดยจัดทำมาตรฐานการตรวจ (Standardized Protocol) เพื่อเปรียบเทียบอ้างอิงยืนยันผลทดสอบ และหลังออกตลาด จะมีการติดตามเฝ้าระวังเหตุการณ์ไม่พึงประสงค์ และข้อร้องเรียนต่างๆ โดยรวบรวมข้อมูลที่มีนัยสำคัญ เพื่อวางแผนสุ่มเก็บตัวอย่าง การตรวจประเมินประสิทธิภาพ และการเรียกคืนผลิตภัณฑ์ เพื่อสร้างความมั่นใจให้กับประชาชนว่า ชุดตรวจมีการกำกับดูแลตรวจสอบคุณภาพอย่างต่อเนื่อง
ด้าน ผศ.นพ.กำธร กล่าวว่า ชุดตรวจ ATK เป็นการตรวจหาโปรตีนของไวรัส แตกต่างจากการตรวจแบบ RT-PCR ที่มีการขยายสารพันธุกรรมไวรัส ทำให้การตรวจด้วย ATK มีความไวน้อยกว่า RT-PCR แต่ปัจจุบันชุดตรวจ ATK อยู่ในระดับดี นำมาใช้ได้ทั่วไปได้ โดยต้องตรวจในจังหวะที่มีโอกาสเจอเชื้อได้มากที่สุด คือ ช่วงก่อนที่จะเริ่มมีอาการ 2 วัน จนถึงมีอาการแล้ว 4-7 วัน แต่ตรวจก่อนหรือหลังจากนี้โอกาสตรวจเจอเชื้อจะน้อยลง ส่วนคนที่ไม่มีอาการและไม่มีการสัมผัสโรค ผลตรวจที่ได้จะมีความน่าเชื่อถือต่ำ อาจเกิดผลบวกปลอม หรือผลลบปลอมกรณีไม่มีอาการแต่มีความเสี่ยง เนื่องจากเชื้อมีปริมาณน้อยจนยังตรวจไม่เจอ จึงต้องระมัดระวัง เนื่องจากหากชะล่าใจอาจแพร่เชื้อสู่ผู้อื่นได้
"การใช้ชุดตรวจ ATK จะมีประโยชน์สูงสุด เมื่อตรวจผู้ที่มีประวัติเสี่ยงสัมผัสโรคและมีอาการ ส่วนการตรวจคัดกรองอาจใช้ในกรณีอยู่ในสถานที่เสี่ยงติดเชื้อสูง เช่น พื้นที่ปิด ร้านอาหาร ร้านตัดผม ชุมชนที่มีคนอาศัยอยู่หนาแน่น ตลาดนัด โรงงาน หรือลูกจ้างในสถานที่นั้นมีการติดเชื้อและมีโอกาสแพร่เชื้อสูง เช่น ห้างสรรพสินค้า ธนาคาร คนทำงานภาคบริการ และคนทำงานที่สัมผัสผู้คนจำนวนมาก โรงเรียน สถานศึกษา โดยการตรวจต่อเนื่องสัปดาห์ละครั้ง ถ้าเสี่ยงมากตรวจ 2-3 ครั้งต่อสัปดาห์ จะลดปัญหาผลลบปลอมในคนเสี่ยงสูง หรือหากยังเป็นผลลบติดต่อกันหลายครั้งและไม่มีอาการ ก็จะมั่นใจได้มากขึ้นว่าเป็นผลลบจริง" ผศ.นพ.กำธรกล่าว
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