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Test Code (รหัสการทดสอบ):
090-70-0070-01

Order Name (ชื่อการทดสอบ):
MERS-CoV, RT-PCR (2 genes, BI Lab)

 
Specimen / Container (สิ่งส่งตรวจ/ภาชนะ):
  1. Combined Nasopharyngeal swab and Throat swab/ Universal Transport Media (UTM) 3 mL, 1 tube
  2. Sputum / Sterile Container
 
Turnaround Time (ระยะเวลารอผล):
Specimen received to reported within 1 day
 
Useful For (ประโยชน์การทดสอบ):
Use for the qualitative detection  of Middle East respiratory syndrome coronavirus (MERS-CoV) in patients with clinical suspicion of MERS-CoV infection and epidemiologic risk.
 
Methodology (วิธีการทดสอบ):
Real Time Polymerase chain reaction (Real-Time PCR) 
 
Test List In Profile (การทดสอบใน Profile):
MERS-CoV (upE gene), RT-PCR 
MERS-CoV (orf1a region), RT-PCR 
 
AliasesName (ชื่อเรียกอื่นๆ) :
Middle East respiratory syndrome coronavirus (MERS-CoV), PCR  
MERS-CoV, PCR
MERS-CoV,Real-time PCR
 
 
 
Test Code (รหัสการทดสอบ):
090-70-0070-01

Order Name (ชื่อการทดสอบ):
MERS-CoV, RT-PCR (2 genes, BI Lab)

 
Collection Specimen Or Container (สิ่งส่งตรวจ/ภาชนะ):
  1. Combined Nasopharyngeal swab and Throat swab/ Universal Transport Media (UTM) 3 mL, 1 tube
  2. Sputum / Sterile Container
 
Specimen Testing Type (สิ่งส่งตรวจที่ใช้ในการทดสอบ):
  1. Combined Nasopharyngeal swab and Throat swab/ Universal Transport Media (UTM) 3 mL, 1 tube
  2. Sputum, minimum volume 0.5 mL
           -  Specimen containers should be sealed with Parafilm® and placed in ziplock bag
           -  Place speicmen in ziplock bag into the plastic bottle as secondary container. 
           -  Send specimens in box with separate compartments for each specimen.
 
Sub Mission Container (ภาชนะส่งตรวจ):
Universal Transport Media (UTM) tube or
Sterile Container 
 
Rejection Criteria (เกณฑ์ปฏิเสธสิ่งส่งตรวจ):
Specimen leaked from container
 
Specimen Stabillity (ความคงตัวของสิ่งส่งตรวจ):
Specimen Type Temperature Time
Combined Nasopharyngeal swab and Throat swab Refrigerated, 2oC to 8oC 7 days
Sputum 
 
 
 
Test Code (รหัสการทดสอบ):
090-70-0070-01

Order Name (ชื่อการทดสอบ):
MERS-CoV, RT-PCR (2 genes, BI Lab)

 
Schedule (ตารางการทดสอบ):
Tested Daily, at 10:00 a.m.and 05:00 p.m.
 
Turnaround Time (ระยะเวลารอผล):
Specimen received to reported within 1 day
 
Performing Location (หน่วยงานที่ทำการทดสอบ):
Molecular biology & Genetics, Laboratory Department Tel.14168
 
Specimen Retention Time (ระยะเวลาเก็บสิ่งส่งตรวจ):
7 days
 
 
 
Test Code (รหัสการทดสอบ):
090-70-0070-01

Order Name (ชื่อการทดสอบ):
MERS-CoV, RT-PCR (2 genes, BI Lab)

 
 
Clinical Information (ข้อมูลทางคลินิก):
In 2012, Middle East Respiratory Syndrome coronavirus, MERS-CoV (formerly named: human coronavirus Erasmus Medical Center, HCoV-EMC), was identified for the first time to cause severe illness in humans. Detection of the virus is preferably done in samples from the lower respiratory tract. Upper respiratory tract
samples (swabs) showed lower virus detection rates. World Health Organization (WHO) recommends the use of two independent PCR assays for confirmation of MERS-CoV cases. Various real-time RT-PCR assays have been published. Two assays, one targeting a region upstream of the E gene (upE) and the other targeting open reading
frame 1a (orf1a), showed the highest sensitivity
 
Reference Value (ค่าอ้างอิง):
Test Reference Value
MERS-CoV (upE gene), RT-PCR Negative
MERS-CoV (orf1a region), RT-PCR  Negative
 
Interpretation (การแปลผล):
  1. Appropriate specimen collection, transport, storage and processing procedures are required for the optimal performance of this test.
  2. The presence of RT-PCR inhibitors (e.g. heparin) may cause false negative or invalid results.
  3. Potential mutations within the target regions of the MERS-CoV genome covered by the primers and/or probes used in the kit may result in failure to detect the presence of the pathogen.
  4. As with any diagnostic test, the test results need to be interpreted in consideration of all clinical and laboratory findings
 
Clinical Reference (เอกสารอ้างอิง):
Manufacturer’s package insert, RealStar® MERS-CoV RT-PCR Kit 1.0, January 2017, altona Diagnostics GmbH, D-22767 Hamburg, Germany.