Jual Reagen PCR(Polymerase Chain Reaction) Harga Distributor

1. Applicable specimen type: nasopharyngeal swab, oropharyngeal swab, alveolar lavage fluid, sputum, serum, whole blood and feces.

2. Collectionof specimen

Nasopharyngeal swab/oropharyngeal swab: Collect sample in accordance with the relevant provisions of “Specimen Collection Method” in the “Pneumonia Laboratory TechnicalGuide for Novel Coronavirus Infection” from “Pneumonia Prevention and Control Plan for Novel Coronavirus Infection”. It is proved that the swab made of nylon sampling head and ABS sampling rod can be selected for sample collection.

Nasopharyngeal swab: The specimen collection tube should be pasted with the barcode first, the nasopharyngeal swab should be collected within 3 days after the onset of the disease as far as possible.Use swab to measure the length between apex nasi and earlobe, then mark with finger. Insert the swab into the nasal cavity in direction of perpendicular to the nose (face). The swab should be inserted at least half of the length from the earlobe to the apex nasi. Make the swab stops in the nasal for 15 ~ 30 s, gently rotate 3 ~ 5 times, quickly put swab into specimen collection tube cotaining 2 mL Lysis Buffer (same as Lysis Buffer in the Sample Release Reagent) or Sample Storage Reagent containing RNA enzyme inhibitor. Insert the swab, then break the sterile swab rod near the top, tighten tube cap and seal withsealing film.

Oropharyngeal swab: The specimen collection tube should be pasted with the barcode first, the oropharyngeal swab should be collected within 3 days after the onset of the disease as far as possible. A sterile flocking swab should be used for sampling, moderately wipe the posterior pharyngeal wall, avoid touching the tongue. Quickly place a sterile swab into the collection tube used for collectionof oropharyngeal swab. Break the sterile swab rod near the top, tighten tube cap and seal with sealing film.

Alveolar lavage fluid: Severe patients or patients with pneumonia who progress rapidly. Clinician extract ≥5 ml BALF into a 50 mL aseptic container labeled with sample bar code and screw cap by aseptic operation. Collect specimen, then tighten tube cap and seal with sealing film.

Sputum: The specimen collectiontube shouldbe pasted with the barcode first.Do not open the airway to collectspecimens when collecting sputum. Collect.deep cough sputum into a disposableaseptic sampling cup withscrew cap, load 2 mLprotease K (1g/L) into sampling cup. Collect sputum, then tighten tube cap and seal with sealing film. Send to detection within 30 min as far as possible. Protease K shouldnot be added first ifspecimens need to be transported over long distances.

Whole blood: Bloodsamplescan be collected within7 days after the onset orcriticalpatients,or patients considered with viremia. The specimen collection tube should be pasted with the barcode first. Collect 2~4 mL of blood samples into vacuum blood collection tube containing EDTA anticoagulant.

Feces: For patients with gastrointestinal symptoms such as diarrhea at the early stage of the disease, preserve 3~5 g (soybean size) feces. The specimen collection tube should be pasted with the barcode first. Collect sample into specimen collection tube with screw cap cotaining 2 mL normal saline (RNAenzyme inhibitor can be added when conditions permit) then seal with sealing film.

After sample collection, itisrecommended to place into Sample Storage Reagent for preservation.

3. Storage and delivery of specimens:

Specimens to be tested can be immediately processed, specimens to be tested within 24 hours can be stored at 4℃. Specimens that cannotbe detected within24 hoursshouldbe stored at-70℃ orbelow(inthe absence of -70℃ storage conditions,specimens to be tested can be stored at -20℃ for 10 days, nucleic acid can be stored at -20±5℃ for 15 days). Multiple freeze/thaw cycles should be avoided. Specimens should be transported in a sealed frozen pitcher with ice or in a sealed foam box with ice. The inactivation of samples at 56℃ for 30min will not affect the detection of this kit.

1. Preparation of reagent (performed at“reagent preparation region”)

1.1 Take out each component from the diagnostickit and place them at room temperature.Allowthe reagents to equilibrate at room temperature, then vortex each of them respectivelyfor later use.

1.2 According to the quantity of test specimens, 2019-nCoV-PCR-Positive Control and 2019-nCoV-PCR-Negative Control, pipette appropriate quantity of 2019-nCoV-PCR Mix and 2019-nCoV-PCR-Enzyme Mix (2019-nCoV-PCR Mix 26 μL/test + 2019-nCoV-PCR-EnzymeMix4μL/test), mixthem thoroughly to makea PCR-Mastermix, centrifuge it instantaneously for later use.

1.3 Transfer the above-prepared reagents to the “specimen processing region” for later use.

2. Processing and loading of specimens (performed at “specimen processing region”)

2.1 Use Sample Release Reagent ( Reference Number : S1014E ), Sample Release Reagent ( Reference Number : S1015E ), NucleicAcid (DNA/RNA) Extraction or Purification Kit (Magnetic beads method) ( Reference Number : S1002E ) manufactured by Sansure Biotech Inc. to extract the nucleic acidas per the product manual.

2.2 Add 30 μLPCR-Mastermixinto PCR reaction tube with 20 μLaboveprocessedsample. Carry out fluorescence quantitative PCR detection on fluorescence PCR instrument. The fluorescent PCR tube can be sealed with 15 μL paraffin oil before PCR amplification.

3. PCRAmplification (Refer to user manual of each instrument to adjust the settings)

3.1 Place PCR reaction tubes into the specimen wells of the amplification equipment. Set up the 2019-nCoV-PCR-Positive Control, 2019-nCoV-PCR-Negative Control and specimens to be tested in the corresponding sequence and input specimen name.

3.2 Select PCR test channel: a) Select FAM (ORF-1ab region) and ROX (N gene) channels to test 2019-nCoV nucleicacid. b) Select CY5 channel to test internal control.

3.3 Set cycle parameters

When the settings are completed, save the settings and carry out the reactionprocedure.

4. ResultAnalysis (Refer to user manual of instrument to adjust the settings.)

Results will be saved automatically when reactions are completed. Analyze amplification curve of target of detection and internal control. Adjust Start, End and Threshold values of Baseline of the graph according to analysis result (Users can adjust the values according to the actual situation. Start value can be set between 3-15, and End value between 5-20.Adjust the amplification curve of negative control to be flat or below threshold). Click “Analyze” to implement the analysis, make sure each parameter satisfy the requirements given in“5. QualityControl”. Go to “Plate” window to record qualitative results.

Diatas adalah beberapa informasi spesifikasi reagen untuk alat Real Time PCR. Beberapa bagian lainnya, seperti :

• Quality Control
• Reference Range
• Explanation of Detection Result
• Limitation of Detection Method
• Product Performa Index, dan
• Precautions

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