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Time-resolved fluorescence immunochromatographic test strip for detecting influenza A virus, influenza B virus and novel coronavirus antigen and preparation method thereof

A technology of influenza B virus and immunochromatographic test paper, applied in the field of medical examination, can solve the problems of long cycle and complicated operation, and achieve the effect of simple operation and convenient clinical diagnosis.

Pending Publication Date: 2020-11-17
深圳市信一生物技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] d. Enzyme-linked immunoassay --- this method is accurate and sensitive, but the operation is complicated and the cycle is long

Method used

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  • Time-resolved fluorescence immunochromatographic test strip for detecting influenza A virus, influenza B virus and novel coronavirus antigen and preparation method thereof
  • Time-resolved fluorescence immunochromatographic test strip for detecting influenza A virus, influenza B virus and novel coronavirus antigen and preparation method thereof
  • Time-resolved fluorescence immunochromatographic test strip for detecting influenza A virus, influenza B virus and novel coronavirus antigen and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Example 1 Time-resolved immunochromatographic test strip for simultaneous detection of influenza A, B and novel coronavirus.

[0038] A time-resolved immunochromatographic test strip for simultaneous detection of influenza A and B viruses and novel coronavirus antigens in this embodiment includes a base plate and a sample pad, a binding pad, a reaction membrane and a water-absorbing pad sequentially arranged on the base plate pad. The binding pad is coated with an equivalent number of fluorescent microspheres labeled influenza A, B and novel coronavirus monoclonal detection antibodies; the reaction membrane includes parallel arrangements and 2mm and 4mm intervals between T1, T2, T3 detection area and control area; the T1 detection area is close to the binding pad, the control area is close to the water-absorbing pad, the T2 and T3 detection areas are located in the middle of the T1 detection area and the control area, and the T2 detection area is close to the T1 detecti...

Embodiment 2

[0048] Example 2 Time-resolved immunochromatographic kit for simultaneous detection of influenza A, B and novel coronavirus antigens.

[0049] The time-resolved fluorescent immunochromatography kit for simultaneous detection of influenza A and B viruses and novel coronavirus antigens in this embodiment, the kit includes: the test strip described in Embodiment 1, a plastic cartridge, and a sample buffer.

[0050] In this embodiment, the sample buffer is PBS buffer containing 0.5% BSA and 0.05% Tween-20, pH 7.4, 0.02mol / L.

[0051] When using the time-resolved fluorescence immunochromatography kit for simultaneous detection of influenza A, B and novel coronavirus antigens of the present invention, the throat swab sample to be tested is added to the sample buffer, and 60 µL of sample is added dropwise on the sample pad to dilute liquid, which transports the sample to the conjugate pad by capillary action. When the throat swab sample contains influenza A and (or) influenza B viru...

Embodiment 3

[0052] Performance measurement of the kit of Example 3.

[0053] The performance of the kit was determined, including the minimum detection limit, precision, sensitivity, specificity, etc.

[0054] 1. The lowest detection limit.

[0055] Its test results are shown in Table 1, and it can be seen from the table that the minimum detection limit of type A H1N1, type A H5N1, type A H3N2, and type A H7N9 is 0.5ng / mL; the minimum detection limit of B / Victoria and B / Yamagata is 1.0ng / mL; the minimum detection limit of the new coronavirus is 0.5ng / mL.

[0056] 2. Intra-batch precision: 10 time-resolved immunochromatography kits of the same batch number were randomly selected to detect the same concentration of influenza A, B and new coronavirus antigen reference products, and the coefficient of variation CV (%) Value ≤ 10%.

[0057] 3. Inter-batch precision: Randomly select three batches of time-resolved immunochromatography kits in a row, and take 3 copies from each batch to test t...

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Abstract

The invention relates to a time-resolved fluorescence immunochromatography test strip for simultaneously detecting influenza A virus, influenza B virus and novel coronavirus antigens in a throat swaband a preparation method thereof. A sample pad, an influenza A virus, influenza B virus and novel coronavirus antibody labeled time-resolved fluorescent microsphere combination pad, a reaction film and a water absorption pad are sequentially adhered to a PVC (polyvinyl chloride) bottom plate in a staggered manner by about 2mm, and then test strips are fixed by an upper plastic clamping shell and alower plastic clamping shell which are matched with each other to form the test card. The reaction film is pre-coated with an influenza A virus capture antibody (T1 detection line), an influenza B virus capture antibody (T2 detection line), a novel coronavirus capture antibody (T3 detection line) and a goat anti-mouse polyclonal antibody (C control line). A time-resolved fluorescence immunochromatography technology is introduced into detection of pharyngeal swab influenza A virus, pharyngeal swab influenza B virus and novel coronavirus, so that the detection time is greatly saved, the detection stability and sensitivity are improved, the operation is simple and convenient, and the kit can be used for field detection; and meanwhile, the time-resolved fluorescence immunochromatography teststrip has the advantages of low cost and high cost performance.

Description

technical field [0001] The invention belongs to the technical field of medical testing, in particular, the invention relates to a time-resolved fluorescent immunochromatographic test strip, a test kit and a preparation method thereof for simultaneously detecting influenza A, B and novel coronavirus antigens. Background technique [0002] Influenza (abbreviated as influenza) is an acute respiratory infection caused by influenza virus, and is a highly contagious and fast-spreading disease. It is mainly spread through droplets in the air, person-to-person contact or contact with contaminated items. Typical clinical symptoms are: high fever, body aches, general fatigue and mild respiratory symptoms. Generally, autumn and winter are the high-incidence period, and the complications and death caused by it are very serious. The disease is caused by influenza virus and can be divided into three types: A, B, and C. Among them, the influenza epidemic caused by Type A is the most wide...

Claims

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Application Information

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IPC IPC(8): G01N33/569G01N33/558G01N33/543G01N33/577G01N21/64
CPCG01N21/6408G01N33/54313G01N33/558G01N33/56983G01N33/577G01N2333/11G01N2333/165
Inventor 胡珊珊胡涛
Owner 深圳市信一生物技术有限公司
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