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Test Code (รหัสการทดสอบ):
090-70-8903

Order Name (ชื่อการทดสอบ):
SARS-CoV-2 (COVID-19) Neutralizing Antibody

 
Specimen / Container (สิ่งส่งตรวจ/ภาชนะ):
Blood/ Plain blood (Red top) 6 mL, 1 tube
 
Turnaround Time (ระยะเวลารอผล):
Received specimen to reported within 4 days
 
Useful For (ประโยชน์การทดสอบ):
  1. Measurement of the neutralising activity of anti-S1/RBD antibodies enables confirmation of their functionality in inhibiting binding of S1/RBD to ACE2 and preventing infection of the host cells. 
  2. Supports the evaluation of the individual immune response following SARS-CoV-2 infection or vaccination with S1/ RBD-based vaccines
 
Methodology (วิธีการทดสอบ):
A surrogate virus neutralization test (sVNT) test in ELISA format for detection of total neutralizing antibodies (IgAGM) targeting S1/RBD
 
AliasesName (ชื่อเรียกอื่นๆ) :
SARS CoV-2 antibody
COVID-19 antibody
COVID-19 Neutralizing Antibody (NT)  
Viral neutralization test (VNT) 
A surrogate virus neutralization test (sVNT) test
Neutralizing 
Neutralizing Antibody
COVID-19
SARS CoV-2
 
 
 
Test Code (รหัสการทดสอบ):
090-70-8903

Order Name (ชื่อการทดสอบ):
SARS-CoV-2 (COVID-19) Neutralizing Antibody

 
Collection Specimen Or Container (สิ่งส่งตรวจ/ภาชนะ):
Blood/ Plain blood (Red top) 6 mL, 1 tube
 
Specimen Testing Type (สิ่งส่งตรวจที่ใช้ในการทดสอบ):
Serum, minimum volume 0.5 mL
 
Sub Mission Container (ภาชนะส่งตรวจ):
Plastic tube
 
Rejection Criteria (เกณฑ์ปฏิเสธสิ่งส่งตรวจ):
Hemolysis: Mild OK, Gross reject
Lipemia: Mild OK, Gross reject
Icteric: Mild OK, Gross reject
 
Specimen Stabillity (ความคงตัวของสิ่งส่งตรวจ):
Specimen Type Temperature Time
Serum Refrigerated, 2oC to 8oC  14 days
 
 
 
Test Code (รหัสการทดสอบ):
090-70-8903

Order Name (ชื่อการทดสอบ):
SARS-CoV-2 (COVID-19) Neutralizing Antibody

 
Method detail (วิธีการทดสอบ):
A surrogate virus neutralization test (sVNT) test in ELISA format for detection of total neutralizing antibodies (IgAGM) targeting S1/RBD
Enzyme-linked Immunosorbent Assay (ELISA)
 
Schedule (ตารางการทดสอบ):
Tuesday and Saturday, at 03:00 p.m. 
 
Turnaround Time (ระยะเวลารอผล):
Received specimen to reported within 4 days
 
Performing Location (หน่วยงานที่ทำการทดสอบ):
Molecular biology & Genetics, Laboratory Department Tel.14168
 
Specimen Retention Time (ระยะเวลาเก็บสิ่งส่งตรวจ):
7 days
 
 
 
Test Code (รหัสการทดสอบ):
090-70-8903

Order Name (ชื่อการทดสอบ):
SARS-CoV-2 (COVID-19) Neutralizing Antibody

 
 
Clinical Information (ข้อมูลทางคลินิก):
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) belongs to the family of coronaviruses and, like SARS-CoV, is classified in the genus Betacoronavirus. At the end of 2019, SARS-CoV-2 was identified as the causative pathogen of clustered cases of pneumonia of unclear origin. The virus caused an infection wave that has spread rapidly worldwide and was declared a pandemic by the WHO at the beginning of 2020.  
The determination of antibodies enables confirmation of SARS-CoV-2 infection in patients with typical symptoms and in suspected cases. It also contributes to monitoring and outbreak control. The spike (S) and nucleocapsid (N) proteins of SARS-CoV-2 are highly immunogenic. To enter and thus infect new cells, the virus binds to the ACE2 receptor of the host cells using the receptor binding domain (RBD) of the spike protein. The RBD is the target antigen of over 90 % of the neutralising antibodies in COVID-19 patients. Neutralising antibodies are associated with protective immunity against a second infection with SARS-CoV-2. The spike protein is therefore the target protein of almost all COVID-19 vaccines. Around 90 % of SARS-CoV-2 patients develop specific antibodies up to day 10 after symptom onset. IgG, IgA and IgM against the spike protein often appear at the same time.
For significant serological results, two patient samples should be investigated, one from the acute phase (week 1 of the illness) and one from the convalescent phase (3 to 4 weeks later). 
 
Interpretation (การแปลผล):
% Inhibition >= 35   = Positive, the results suggest prior infection with SARS-CoV-2 or vaccination against SARS-CoV-2. Measurement of the neutralising activity of anti-S1/RBD antibodies enables confirmation of their functionality in inhibiting binding of S1/RBD to ACE2.

% Inhibition <20   = Negative, the results may occur in samples collected too soon following infection or immunization, or in immunocompromised patients. In cases of recent SARS-CoV-2 infection or vaccination, re-testing is recommended after 14 days. 

% Inhibition >= 20 to < 35   = Borderline, the presence or absence of neutralizing antibodies cannot be concluded. Borderline samples have either very low antibody titers or are negative for antibodies that neutralize SARS-CoV-2. Re-testing recommended after 14 days.
Negative results do not rule out SARS-CoV-2 infection, the results should always be interpreted together with those of further laboratory diagnostic procedures and based on the clinical picture. 
The test results should not be used to diagnose acute SARS-CoV-2 infection. Antibody tests can identify persons with resolving or past SARS-CoV-2 infection.
 
Clinical Reference (เอกสารอ้างอิง):
Manufacturer’s reagent package insert, SARS-CoV-2 NeutraLISA instruction, August 2021, EUROIMMUN, Lübeck, D-23560 Germany.