HSV I IgG Elisa test

INTENDED USE

HSV I IgG Elisa test is intended for qualitatively detecting the presence or absence of human IgG class antibodies to HSV-1 in human sera. In conjunction with the test is indicated for testing sexually active adults or expectant mothers for aiding in the presumptive diagnosis of HSV infection. The predictive value of a positive or negative result depends on the population’s prevalence and the pretest likelihood of HSV-1 infection. The assay can be used manually or in conjunction with an automated system as outlined in the package insert. The user is responsible for assay performance characteristics when an automated system is used.

Major Components

1. Microplate 96 wells 7. Substrate Solution A 6 mL ×1

2. Negative Control 1.0 mL ×1 8. Substrate Solution B 6 mL ×1

3. Positive Control 1.0 mL ×1 9. Stop Solution 6 mL ×1

4. Sample Diluent 12 mL ×1 10. Plate Cover 3 pieces

5. Conjugate 12 mL ×1 11. Insert 1 copy

6. Washing Buffer 50 mL ×1

ASSAY PROCEDURE

• Prepare Reagents: Dilute 1 volume of Washing Buffer (20×)with 19 volumes of distilled water, mix well.
• Add Samples: Open the foil pouch and remove the Microplate. Set up 1 well as Blank, 2 wells as negative control, 2 wells as positive control. After dispensing 100μL of Sample Diluent , dispense 10μL of sample, 100μL negative control or positive control to the respective wells(without Sample Diluent). Gently vibrating the plate.
• Incubate: Cover the Microplate with plate cover and incubate the Microplate in a thermostat-controlled water-bath or microplate incubator at 37℃ for 30 minutes.
• Wash the Plate: Remove the plate cover. Aspirate the contents of all wells. Fill the wells with the diluted washing buffer ( 10~20 seconds to soak) then aspirate again. Repeat the procedure for 5 times. Make sure that the rest volume is minimal, by tapping plate onto absorbent paper.
• Add Conjugate: Add 100μL of conjugate to each well (except the blank well).
• Incubate: Cover the Microplate and incubate the plate at 37℃ for 30 minutes.
• Wash the Plate: Repeat the wash procedure as in step 4.
• Add Substrate: Add 50μL of Substrate Solution A and 50μL of Substrate Solution B to each well, mix well. Cover and incubate at 37℃ for 15 minutes.
• Stop reaction: Add 50μL Stop Solution to each well, mix well.
• Read the absorbance at 450 nm. If a dual wavelength measurement is used, the reference wavelength should be selected from 620nm to 690nm.

Biovantion Inc is independent from international department of Bioneovan Co., Ltd., which established in 2 0 0 5, is an in vitro diagnostic reagents manufacturer engaged in the research, development, production, and focus on clinical testing for infectious diseases, such as Hepatitis virus, Noro virus, Parvo virus test kits, our products include rapid test cassette and Elisa kits.

All our products have been registered in National Medical Products Administration of China, in year 2020 we get Certificate of ISO 13485:2016 – QUALITY MANAGEMENT SYSTEMS FOR MEDICAL DEVICES from SGS. More importantly, we have awarded the registration certificate from National Medical Products Administration for Diagnostic Kit for IgM Antibody to COVID-19 and IgG antibody to COVID-19 during the outbreak in China, and also we developed COVID-19 Antigen test ; Neutralizing Antibody Test, these products selling well all overthe world