Quality control product, preparation method thereof, kit and method for detecting trisomy 21 and 18 syndromes of fetuses
A quality control product and three-body technology, applied in biochemical equipment and methods, microbiological determination/inspection, etc., can solve the problems of high detection cost, long detection cycle, high technical threshold, etc., and achieve positive detection rate and detection accuracy The effect of improving the performance and ensuring the detection sensitivity
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[0047] The preparation of described positive class reference product:
[0048] 1) Preparation of P21
[0049] Extract the cellular genomic DNA of the T21 trisomy-positive cell line, break it up by ultrasound, and obtain a fragmented T21 trisomy-positive cell line DNA solution that is close in size to the DNA extracted from maternal plasma and the fetal free DNA in the maternal plasma. The P21 solution is obtained by mixing the degraded T21 trisomy-positive cell line DNA solution with the isolated plasma DNA solution of normal non-pregnant women, wherein the content of the fragmented T21 trisomy-positive cell line DNA solution is 10- 20%wt;
[0050] 2) Preparation of P18
[0051] Extract the cellular genomic DNA of the T18 trisomy-positive cell line, break it with ultrasound, and obtain a fragmented T18 trisomy-positive cell line DNA solution that is close in size to the DNA extracted from the maternal plasma and the fetal free DNA in the maternal plasma. The P18 solution is...
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