Quality Inspection for Hcv Genotype Assay - Macro & Micro-Test Sample Release Reagent – Macro & Micro-Test

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Quality Inspection for Hcv Genotype Assay - Macro & Micro-Test Sample Release Reagent – Macro & Micro-Test Detail:

Product name

Macro & Micro-Test Sample Release Reagent

Certificate

CE, FDA, NMPA

Features

Rapid: only 5 mins.

Easy: only 3 steps (1.add the sample 2.Mix upside and down 10 times 3. Leave it for 5 mins).

Main components

Name	Main components	Component specifications	Quantity
Sample Release reagent	Dithiothreitol, sodium dodecyl sulfate (SDS), RNase inhibitor, surfactant, purified water	0.5mL/Vial	50 Vial

Note: Components in different batches of kits are not interchangeable.

Storage conditions and shelf life

Store and transport at room temperature. The shelf life is 24 months.

Applicable instruments

Instruments and equipment during sample processing, such as pipettes, vortex mixers, water baths, etc.

Sample requirements

Freshly collected oropharyngeal swabs, nasopharyngeal swabs.

Precision

When this kit is used for extraction from the in-house precision reference CV for 10 replicates, the coefficient of variation (CV, %) of Ct value is not more than 10%.

Inter-batch difference

When the in-house precision reference is tested on three batches of kits under trial production upon repeated extraction and, the coefficient of variation (CV, %) of Ct value is not more than 10%.

Performance comparison

● Extraction efficiency comparsion

Efficiency comparsion of magnetic beads method and sample releaser
concentration copies/mL	magnetic beads method		sample releaser
concentration copies/mL	orfab	N	orfab	N
20000	28.01	28.76	28.6	29.15
2000	31.53	31.9	32.35	32.37
500	33.8	34	35.25	35.9
200	35.25	35.9	35.83	35.96
100	36.99	37.7	38.13	undet

The extraction efficiency of sample releaser was similar to that of magnetic beads method, and the concentration of pathogen could be 200Copies/mL.

● CV value comparison

Repeatability of sample releaser extraction
concentration:5000Copies/mL	ORF1ab	N
	30.17	30.38
	30.09	30.36
	30.36	30.26
	30.03	30.48
	30.14	30.45
	30.31	30.16
	30.38	30.7
	30.72	30.79
CV	0.73%	0.69%

When tested at 5,000 copies /mL, the CV of orFab and N was 0.73% and 0.69%, respectively.

Macro & Micro-Test Sample Release Reagent10

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