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290 results about "Reference product" patented technology

A reference product is the single biological product, already approved by FDA, against which a proposed biosimilar product is compared. A reference product is approved based on, among other things, a full complement of safety and effectiveness data.

Quantitative detection kit of hepatitis B virus (HBV) nucleic acid

The invention discloses a quantitative detection kit of a hepatitis B virus (HBV) nucleic acid applied to the field of biomedical clinic diagnosis. The kit comprises a paramagnetic particle method extraction kit and an HBV nucleic acid amplification kit, wherein the paramagnetic particle method extraction kit comprises a pyrolysis binding solution, a rinsing solution, an eluant and magnetic bead liquid; the HBV nucleic acid amplification kit comprises an HBV-PCR (Polymerase Chain Reaction) reaction solution, an enzyme mixed solution, an HBV-interior label, HBV quantitative reference products 1-4, a negative quality product, a clinical positive quality product and a strong positive quality product. The quantitative detection kit is simple, convenient and fast in operation, low in cost, high in detection sensitivity, good in repeatability, high in conservative property of primer and probe, and strong in specificity, and covers different subtypes or variants of the hepatitis B virus, improvement of the accuracy and the specificity of the hepatitis B detection is facilitated, an efficient interior label system is led in, the problems such as reciprocal inhibition, interference and the like caused by simultaneous amplification of a target gene and the interior label are solved, the overall PCR amplification process can be effectively monitored, and a false negative result is avoided.
Owner:东北制药集团辽宁生物医药有限公司

Herpes virus type I PCR (polymerase chain reaction) fluorescence quantitative rapid test kit and method

The invention aims at providing a herpes virus type I PCR (polymerase chain reaction) fluorescence quantitative rapid test kit which can detect the specific nucleic acid sequence of pure herpes virus type I in a clinical sample and further achieve the purpose of rapidly judging the existence of the pure herpes virus type I. In order to realize the purpose, the technical scheme of the invention isas follows: the herpes virus type I PCR fluorescence quantitative rapid test kit provided by the invention comprises a DNA (deoxyribonucleic acid) extraction solution, a PCR reaction solution, a DNA polymerase, a positive quality control product, a weak positive quality control product, a negative quality control product and a quantitative reference product, wherein the PCR reaction solution comprises primers and a fluorescent probe, and the primers are divided into an upstream primer and a downstream primer. The herpes virus type I PCR fluorescence quantitative rapid test kit has the beneficial effect of filling in the blank of a fluorescence PCR kit for clinically detecting the pure herpes virus type I (HSV I) in China. Furthermore, a Taqman core technology platform and an arabidopsis thaliana internal control system are utilized for detecting the pure herpes virus type I (HSV I), so that the herpes virus type I PCR fluorescence quantitative rapid test kit has the advantages of highsensitivity, high specificity, stability, timeliness, convenience in operation and the like.
Owner:泰普生物科学(中国)有限公司

Fluorescent standard card and test method for calibration and quality control of fluorescent immunoassay analyzer

InactiveCN109633189ALinear dependencies can be assessedImprove consistencyFluorescence/phosphorescenceReference productEngineering
The invention discloses a fluorescent standard card for calibration and quality control of a fluorescent immunoassay analyzer. The fluorescent standard card comprises a fluorescent standard card bodyand a fluorescent detecting unit. The fluorescent detecting unit is made of a fluorescent solution, a photocurable fluorescent material, fluorescent printing ink or fluorescent ink. Compared with theuse of a quality control product, reference product or standard product, the fluorescent standard card has the characteristics of stable luminescent properties, being not easy to decay with time, highline width precision, uniform spatial distribution of fluorescent substances, linearity of fluorescent substance amount and fluorescent intensity and great preparation consistency. The invention further discloses a test method. The method and parameters of a fluorescent standard card evaluation device are established. The method has the advantages of complete evaluation content and easy operation, is a systematic measurement and evaluation scheme, is beneficial for calibration and quality control of the fluorescent immunoassay analyzer, and improves the detection accuracy of the fluorescent immunoassay analyzer. The traceability scheme of each method can reliably ensure that the properties of the fluorescent standard card are strictly controlled during production and use.
Owner:SHENZHEN KINGFOCUS BIOMDICAL ENG CO LTD

LAMP visual rapid detection kit of silkworm pathogenic micro spore worms and detection method thereof

The invention relates to the technical field of biology, and discloses a LAMP visual rapid detection kit of silkworm pathogenic micro spore worms and a detection method of the LAMP visual rapid detection kit of the silkworm pathogenic micro spore worms. The kit comprises four LAMP primers, deoxyribonucleic acid (DNA) lysate liquid, LAMP reaction liquid, positive reference products, negative reference products and color development liquid to form a detection reaction system. Under the constant temperature of 60 DEG C to 65 DEG C, formwork DNA is rapidly amplified, developed dye is added to the formwork DNA, and identification results are observed through naked eyes under natural light. If the color of reaction products changes into green, the fact that samples to be tested contain the silkworm pathogenic micro spore worms is confirmed, and if the color of reaction products changes into orange, the fact that the samples to be tested do not contain the silkworm pathogenic micro spore worms is confirmed. The kit can detect current various silkworm pathogenic micro spore worms fast and flexibly, is easy to operate, and low in cost, and needs no special or complex instruments, and reaction results are easy to judge, and specificity is strong. The kit can meet the urgent needs of disease surveillance, on-site emergency situation and the detection of production samples, and can be widely popularized and applied easily.
Owner:SOUTH CHINA AGRI UNIV

Tumor mutation burden standard substance, and preparation method and kit thereof

The invention provides a tumor mutation burden standard substance, and a preparation method and application thereof. The tumor mutation burden standard substance is obtained by mixing extracted genomeDNA of 6 pairs of paired cell lines according to a certain proportion. Through whole exon sequencing, a gradient reference substance is sequenced; and a tumor mutation burden value of the corresponding gradient reference substance is calculated through a specific biological information algorithm. For a detection limit reference product, a tumor cell sample is diluted by a normal cell sample in paired samples; and a droplet digital PCR method is used for verifying the dilution proportion for ensuring the mixing to conform to the expectation, so that the complexity of clinic samples and the specificity and sensitivity of an inspection and testing system are simulated to a maximum degree. The product can be used for evaluating the performance of tumor mutation burden detection products, andcan also be used for algorithm optimization or detection flow process optimization of the tumor mutation burden. The tumor mutation burden standard substance is applicable to high-flux sequencing strategies of whole exon and targeted genome or exome subsets.
Owner:菁良科技(深圳)有限公司
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