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Test Code (รหัสการทดสอบ):
090-30-2762

Order Name (ชื่อการทดสอบ):
SARS-CoV-2 (Covid-19) Spike IgG Antibody-Quantitative

 
Specimen / Container (สิ่งส่งตรวจ/ภาชนะ):
Plain Blood 6 mL (Red Top) 1 tube
 
Turnaround Time (ระยะเวลารอผล):
Specimen collected to reported within 2:00 Hours (120 mins)
 
Useful For (ประโยชน์การทดสอบ):
  1. Determination of IgG antibodies to SARS-CoV-2 in human serum. 
  2. Used as an aid in evaluating immune status of infected individuals and to monitor antibody response in individuals that have received the COVID-19 vaccine, by quantitatively measuring IgG antibodies against the spike receptor-binding domain (RBD) of SARS-CoV-2. 
  3. Results from the SARS-CoV-2 IgG II Quant assay should not be used as the sole basis for diagnosis of SARS-CoV-2 infection.
 
Methodology (วิธีการทดสอบ):
Chemiluminescent microparticle immunoassay (CMIA)
 
AliasesName (ชื่อเรียกอื่นๆ) :
Covid
Covid antibody
Covid IgG
Covid Ig
Spike IgG
Spike
 
 
 
Test Code (รหัสการทดสอบ):
090-30-2762

Order Name (ชื่อการทดสอบ):
SARS-CoV-2 (Covid-19) Spike IgG Antibody-Quantitative

 
Collection Specimen Or Container (สิ่งส่งตรวจ/ภาชนะ):
Plain Blood 6 mL (Red Top) 1 tube
 
Specimen Testing Type (สิ่งส่งตรวจที่ใช้ในการทดสอบ):
Serum, minimum volume 1 mL
 
Sub Mission Container (ภาชนะส่งตรวจ):
Plastic vial
 
Rejection Criteria (เกณฑ์ปฏิเสธสิ่งส่งตรวจ):
Hemolysis: 4+

 
 
Specimen Stabillity (ความคงตัวของสิ่งส่งตรวจ):
Specimen Type Temperature Time
Serum  Refrigerated, 2oC to 8oC 7 days
  Freeze, -20oC 1 month
 
 
 
Test Code (รหัสการทดสอบ):
090-30-2762

Order Name (ชื่อการทดสอบ):
SARS-CoV-2 (Covid-19) Spike IgG Antibody-Quantitative

 
Method detail (วิธีการทดสอบ):
Chemiluminescent Microparticle Immuno Assay (CMIA)
 
Schedule (ตารางการทดสอบ):
Tested Daily (24 Hours)
 
Turnaround Time (ระยะเวลารอผล):
Specimen collected to reported within 2:00 Hours (120 mins)
 
Performing Location (หน่วยงานที่ทำการทดสอบ):
Immunology, Laboratory Department Tel. 13227
 
Specimen Retention Time (ระยะเวลาเก็บสิ่งส่งตรวจ):
5 days
 
 
 
Test Code (รหัสการทดสอบ):
090-30-2762

Order Name (ชื่อการทดสอบ):
SARS-CoV-2 (Covid-19) Spike IgG Antibody-Quantitative

 
 
Clinical Information (ข้อมูลทางคลินิก):
The SARS-CoV-2 IgG II Quant assay is designed to detect immunoglobulin class G (IgG) antibodies, including neutralizing antibodies, to the receptor binding domain (RBD) of the S1 subunit of the spike protein of SARS CoV-2 in serum and plasma from individuals who are suspected to have had coronavirus disease (COVID-19) or in serum and plasma of individuals that may have been infected by SARS-CoV-2.

The SARS-CoV-2 IgG II Quant assay has demonstrated the ability to detect the spike RBD-based vaccine response in longitudinal samples from individuals both with and without prior COVID-19 infection.
 
Interpretation (การแปลผล):
Result < 50 AU/mL (Negative):
May occur in serum collected too soon following infection or vaccination, in immunosuppressed patients or in patients with asymptomatic infection. This test does not rule out active and/or recent COVID-19 infection or vaccination.

Result > or = 50 AU/mL (Positive):
Indicate presence of IgG antibody against the spike receptorbinding domain (RBD) of SAR-CoV-2. These results suggest recent or prior SARS-CoV-2 infection and/or vaccination. Correlation with epidemiologic risk factors and other clinical laboratory findings is recommended.
 
Clinical Reference (เอกสารอ้างอิง):
Manufacturer’s Reagent package insert, Architect SARS-CoV-2 IgG II Quant, April 2021, Abbott Ireland Diagnostics Division, Finisklin Business Park, Sligo, Ireland.