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Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Group B Streptococcus

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Category:Reproductive health testing

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Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Group B Streptococcus

This kit is intended for the in vitro qualitative detection of the nucleic acid DNA of group B streptococcus in rectal swab samples, vaginal swab samples or mixed rectal/vaginal swab samples from pregnant women at 35 to 37 gestational weeks with high risk factors and at other gestational weeks with clinical symptoms such as premature rupture of membrane and threatened premature labor.
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Introduction

Packing specification

50 tests/kit

 

Intended use

This kit is intended for the in vitro qualitative detection of the nucleic acid DNA of group B streptococcus in rectal swab samples, vaginal swab samples or mixed rectal/vaginal swab samples from pregnant women at 35 to 37 gestational weeks with high risk factors and at other gestational weeks with clinical symptoms such as premature rupture of membrane and threatened premature labor.

This kit provides an auxiliary means for the diagnosis of GBS infection in pregnant women during the perinatal period. The test results are for clinical reference only, and the final diagnosis must be comprehensively analyzed with combination with other clinical indicators.

 

Main components

 

Sample collection

1. Freshly collected swab samples of genital tract and rectal secretions.

2. Wipe the excess secretions of the vulva, then place a sterile swab to the lower 1/3 of the vagina and rotate it to wipe the excess vaginal secretions. Place the swab after sampling in a sterile swab tube, seal the tube and submit it for detection;

3. Place a sterile swab on 2-3cm of the anal sphincter and rotate it gently to obtain rectal secretions. Place the swab after sampling in a sterile swab tube, seal the tube and submit it for detection;

4. It is recommended that the above-mentioned two kinds of swabs after sampling be placed in the same sterile swab tube and submitted for detection in a sealed manner to increase the positive detection rate;

5. It is recommended that the examinee avoid using any antibiotics and lotions within one week before sampling.

 

Sample processing

1. Add 1-3 mL of sterile normal saline to the sterile tube containing the swab specimen, shake and mix thoroughly, squeeze the cotton swab and discard the cotton swab.

2. Pipette 1mL of liquid into a 1.5mL RNase-free & DNase-free centrifuge tube, centrifuge at 12000rpm for 3min, discard the supernatant and keep the precipitate.

3. Add 180μL of lysozyme buffer to the precipitate (dilute the lysozyme to 20mg/mL with lysozyme diluent), pipette to mix, and treat at 37°C for more than 30 minutes.

4. Take 1.5mL RNase-free & DNase-free centrifuge tube, and add 200μL of positive control and negative control in sequence. Add 3μL of internal reference control to the sample to be tested, positive control, and negative control in sequence, and use the recommended nucleic acid extraction reagents for subsequent sample DNA extraction. Please strictly follow the instructions for use for specific steps. The recommended elution volume is 100μL.

5. After heating the extracted sample DNA at 95°C for 3 minutes, immediately place it in ice bath for 2 minutes and then load the sample to the instrument for detection; if the sample is stored below -18°C, before the detection, heat the sample DNA at 95°C for 3 minutes, immediately place it in ice bath for 2 minutes and then load the sample to the instrument for detection. Avoid repeated freezing and thawing.

Note: the sample DNA that has been processed by heating and ice bath should be immediately pipetted and loaded on the instrument for detection; or immediately pipetted and then loaded on the instrument for detection after being placed at 2-8°C for no more than 4h.

 

Applicable instruments and equipment

ABI 7500 fluorescence quantitative PCR instrument and Shanghai Hongshi SLAN-96P fluorescence quantitative PCR instrument

Key words:
Nucleic Acid
EPIA
Group B
Streptococcus
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