Packaging Specifications

24 people per box, 1 second; 24 servings per box, 2 seconds; 24 servings per box, 3 seconds; 24 servings per box, 4S; 24 servings per box, 5S. The corresponding item numbers are respectively: 24-1S; 24-2S; 24 to 3 seconds; 24-4S; 24-5 seconds.

Intended Use

It is used for high-throughput sequencing and obtaining sample sequence information, but is not suitable for whole genome sequencing. If it is necessary to detect the data of specific genes, it should be used in conjunction with specific reagents. 
Principle of Inspection

This kit provides a basic buffer system for high-throughput sequencing, combined with specific reagents for a particular gene. It adopts a method of synthesizing and sequencing simultaneously. A multi-channel fluorescence quantitative analyzer can collect and detect the specific fluorescence signals released during the DNA polymerization process, that is, by detecting the changes in fluorescence signals in the reaction system, base information can be obtained.

Main components

Reagents and consumables to be prepared by yourself

1. No consumables such as pipette tips and pipettes with nuclease filter cores;

2. Specific reagents that go with it;

Storage Conditions and Validity Period

Storage conditions: Store at -20 ±5℃. Valid for 12 months. The number of freeze-thaw cycles shall not exceed 8 times.

Applicable Instruments

Sequencing applicable instrument: Multi-channel fluorescence quantitative analyzer

Sample Requirements

EDTA anticoagulates fresh blood and oral exfoliated cells

Inspection Method

Take out the universal sequencing reaction kit, balance it to room temperature, fully thaw it, then invert and mix it 10 times, and centrifuge rapidly for 10 seconds for later use.

The corresponding specific reagents were balanced to room temperature, fully thawed, then inverted and mixed 10 times, and rapidly centrifuged for 10 seconds for later use.

Add 450μL of the general reaction solution to the specific reagent that comes with each tube to form the sequencing reaction solution. Thoroughly invert and mix 10 times, then rapidly centrifuge for 10 seconds and set aside for later use.

Add the sequencing reaction solution to the sequencing consumables at a rate of 23μL per tube, and then add 2μL of the template of the column to be sequenced. The final volume of the liquid is 25μL.

Place the sequencing consumables into the multi-channel fluorescence quantitative analyzer, select the corresponding sequencing program in the software, and start running.

Run sequencing experiments

Interpretation of the Test Results

The sequencing results of the samples to be tested are determined based on the built-in software of the multi-channel fluorescence quantitative analyzer.

Limitations of the Testing Method

The sequencing results of this time are only responsible for this sample.

The test results are for clinical reference only and cannot be the sole basis for diagnosis and treatment.

Product performance indicators

The appearance of the reagent kit is clean and tidy, the printed and label information is clear and accurate, and there is no leakage.

The reagent is clear after melting, without turbidity or sediment.

The amount of reagent in the reagent tube shall not be less than the nominal weight indicated on the label of the reagent tube.

Accuracy: Test the accuracy reference sample, and the result conforms to the characteristics of the reference sample.

Sensitivity, detection sensitivity reference sample, the result conforms to the characteristics of the reference sample;

Blank control, negative test control, result negative.

Notes

1.This product is only for in vitro diagnosis. Please read this instruction manual carefully before use.

2.During the experiment, one should wear work clothes and protective measures such as rubber gloves.

3.During the experiment, strictly pay attention to the operation. It is recommended to use pipette tips with filter elements to prevent contamination and false positive results.

4.All chemical reagents are potentially dangerous. The operator must strictly follow this instruction manual when using this reagent kit. Used reagent kits do not need to be disposed of as infectious substances, but they should be treated as medical waste.

5.The test results of this kit can be affected by factors such as the sample collection process, sample quality, sample transportation conditions, and sample pretreatment. At the same time, they are also restricted by the operating environment and the limitations of current molecular biology techniques, which may lead to false positive or false negative test results. Users must be aware of the potential errors that may exist during the detection process and the limitations of accuracy.

6.All reagents in this kit have been specially formulated. Components from different batch numbers of kits must not be mixed with each other.

Explanation of the logo

Product Number	Temperature range	Product batch number	Repackaging quantity	Valid until

Basic information

Name of the manufacturing enterprise: Wuhan Gaoyanzhi Biotechnology Co., LTD

Address: Room 301, No. 4 Factory, 3rd Floor, Building B10, Gaoke Medical Device Park, No. 818, Gaoxin Avenue, bao 澥 street, East lake new technology development Zone, wuhan City, Hubei Province

Production Address: Room 301, No. 4 Factory, 3rd Floor, Building B10, Gaoke Medical Device Park, No. 818, Gaoxin Avenue, bao 澥 street, East lake new technology development Zone, wuhan City

Contact Information: 027-63499179

Name of the entrusted enterprise: Wuhan Anzhiyin Medical Technology Co., LTD

The trustee's address is: No. 2 Factory, 5th Floor, Building B10, Phase I, Plot B, Wuhan Gaoke Medical Device Park, No. 818, Gaoxin Avenue, East Lake New Technology Development Zone, Wuhan

The production address of the entrusted party is: Factory No. 2, 5th Floor, Building B10, Phase I, Plot B, Wuhan Gaoke Medical Device Park, No. 818, Gaoxin Avenue, East Lake New Technology Development Zone, Wuhan

Contact Information: 027-63499179

Medical device production filing certificate number: Ehan Pharmaceutical Supervision Medical Device Production Filing No. 20240164
The date of approval and modification of the instruction manual: Approval date: April 28, 2023
Medical device filing certificate filing number: Ehan Medical Device Filing No. 20230162