Rapid test for IgM antibody to Respiratory Syncytial Virus (Colloidal Gold)

Intended Use

This kit is used to qualitatively detect the existence of Respiratory Syncytial Virus(RSV)IgM antibodies in whole blood, serum or plasma sample, as an auxiliary clinical diagnostic reagent of RSV infection in early stage. RSV(Respiratory Syncytial Virus) is an RNA virus, belongs to paramyxoviridae pneumoniaean RSV can cause lower respiratory tract infection in infants and young children, and is the main pathogen of viral pneumonia and bronchiolitis in infants and young children, especially children under 2 years old. RSV infection in human body passes through the incubation period,then IgM antibodies appear during 2 to 7 days, and IgM begins to decline 8 to 40 days, which provides a basis for the clinical diagnosis and early diagnosis of RSV infection [8]

Main Constituent

Test Card (Coating the recombinant RSV rNP antigen on T-line, the goat anti-mouse IgG antibody on C-line): 20 test cards/ box
1.The sample diluent: 1 bottle (5 ml)
2.Product instruction: 1

Storage conditions and the period of validity

Store at 4～30℃, dry places for 24 months. Use test card within 1 hour once open to atmosphere when the humidity is below 60%, or use it immediately if the humidity is higher.

Test Procedure

1.Test preparation: 10μL, 100μL micropipettes and matched tips
2.Test process: The temperature of the kit and the test sample should be the same with room temperature before test. Place the test card on a dry horizontal work surface.
3.Add 10μL serum/plasma or 20μL whole blood sample into the sample well, then add 80 μL of sample dilution immediately.
4.Observe the result in 15-20 minutes after the serum or plasma samples added. The observation is invalid after 20 minutes.

Test results explain

To develop color on C line only: negative; To develop color on both C line and T line: positive; To develop color on T line only: invalid; Not to develop color on both C line and T line: invalid.
Note: Re-detection if the detection result is invalid. The invalid test cards should be dealt as infectious pollutants. The temperature of the kit and the test sample should be the same with room temperature before pre-detection.

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