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OEM Neutralizing Ab Test Uncut Sheet Sandwich Method

Hangzhou Aichek Medical Technology Co.,Ltd
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Address: 3rd Floor, Building 9, Hexiang Technology Center, Xiasha Street, Qiantang District, 310018 Hangzhou, Zhejiang, P.R. China

Contact name:Edward YU

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Hangzhou Aichek Medical Technology Co.,Ltd

OEM Neutralizing Ab Test Uncut Sheet Sandwich Method

Country/Region china
City & Province hangzhou zhejiang
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Product Details

uncut sheet for 2019-nCov neutralizing Antibody test Sandwich Method

 

 

Product Name

uncut sheet for 2019-nCov neutralizing Antibody test Sandwich Method

Formats

Strip(3mm)Device(4mm) uncut sheet

Place of Origen

China

Specimen

Blood

Read Time

15 minutes

Shelf life

2 years

Package

uncut sheet

Storage

2℃-30℃

For professional and in vitro diagnostic use only.

 

[INTENDED USE]

 

The product is suitable for qualitative detection of neutralizing antibodies (NAbs) against SARS-CoV-2 that block the interaction between the receptor binding domain (RBD) of the spike glycoprotein and the Angiotensin converting enzyme Ⅱ (ACE2) receptor. The device can be instrumental in vaccine and therapeutic development as it is suitable for all antibody isotypes. It may also help in current COVID-19 investigations of sero-prevalence, assessment of human immunity, longevity of protective immunity, efficacy of different vaccine candidates as well as tracking infection.

 

[PRINCIPLE]

 

The Device uses the principle of the Surrogate Virus Neutralization Test method for detecting the neutralizing antibody against SARS-CoV-2 in human/animal specimens. The marker is composed of the recombinant spike glycoprotein (SP) labeled with Dye. When testing, the specimen was added into the sample well and migrated to the absorbent pad by the capillary effect. If there are enough NAbs contained in the specimen, it will react with the marker and block the marker captured by the ACE2 coated in the NC membrane. Then there is no colored line produced at the test area (T), indicating a positive result. If the NAbs not enough, the test region will show weak T line. If there are no NAbs, the T line will show and it means a negative result. Regardless of whether the Nab exists, as a procedural control, a colored line will always appear at the control area (C), indicating that proper volume of specimen has been added and the correct test procedure is conducted.

 
Uncut Sheet for SARS-CoV-2 Diagnosis
 
ProductLOT NOSizeSample TypeLOD
Uncut Sheet for SARS-CoV-2 Antigen (Colloidal Gold)SC2N8026cm*30cmSaliva

50-100

TCID50/mL

SC2N8046cm*30cmSwab

50-100

TCID50/mL

Uncut Sheet for SARS-CoV-2 Antigen (Latex)SC2N8146cm*30cmSaliva

40

TCID50/mL

SC2N8136cm*30cmSwab

20

TCID50/mL

Uncut Sheet for SARS-CoV-2 nAb (Competition Method)SC2NAb8016cm*30cmS/P/WB200ng/mL
Uncut Sheet for SARS-CoV-2 nAb (Sandwich Method)SC2NAb8016cm*30cmS/P/WB150 ng/mL
Uncut Sheet for SARS-CoV-2 IgG/IgMSC2GMAb8016cm*30cmS/P/WB/

 

uncut sheet

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