Group B Streptococcus nucleic acid detection kit(Enzymatic Probe Isothermal Amplification)
1.Detection significance
Group B streptococcus (GBS) is normally colonized in women's vagina and rectum, which can lead to early invasive infection (GBS-EOS) in newborns through vertical transmission from mother to child, and is the main cause of neonatal pneumonia, meningitis, septicemia and even death. In 2021, the Expert Consensus on Clinical Management of High-risk Newborns with Early-onset Infection in the Same Room of Mothers and Infants of China Maternal and Child Health Association suggested that GBS screening 35-37 weeks before delivery and intrapartum antibiotic prevention (IAP) were effective measures to prevent GBS-EOS in newborns.
2. Challenges faced by current detection methods
Premature rupture of membranes (PROM) refers to the rupture of membranes before labor, which is a common complication in perinatal period. Premature rupture of membranes Due to the rupture of membranes, GBS in the vagina of parturient women is more likely to spread upward, resulting in intrauterine infection. The risk of infection is in direct proportion to the growth at the time of rupture of membranes (> 50% of pregnant women give birth within 1-2h hours after rupture of membranes, or even 1-2 hours).
The existing detection methods can not fully meet the requirements of timeliness (< 1h), accuracy and on-call GBS detection during delivery.
| Detection instruments | Bacterial culture | Culture time : 18-24hIf the drug sensitivity test : increase 8-16h | 60 % positive detection rate ; during the sampling process, it is susceptible to bacteria such as Enterococcus faecalis around the vagina and anus, resulting in false negative / false positive results. |
| Immunochromatography | Detection time : 15min. | The sensitivity is low, and it is easy to miss detection, especially when the amount of bacteria is small, it is difficult to detect, and the guidelines are less recommended. | |
| PCR | Detection time : 2-3h | The detection time is more than 2 hours, and the PCR instrument needs to be tested in batches, and it is not possible to follow the test. |
3. Macro & Micro-Test product highlights
Rapid detection: Using the patented enzyme digestion probe constant temperature amplification method, positive patients can know the result as soon as 5 minutes.
Detection at any time, no need to wait: it is equipped with a constant temperature nucleic acid amplification analyzer Easy Amp, and the four modules run independently, and the samples are inspected as they arrive, so there is no need to wait for samples.
Multi-sample type: vaginal swab, rectal swab or mixed vaginal swab can be detected, which meets the recommendation of GBS guidelines, improves the positive detection rate and reduces the misdiagnosis rate.
Excellent performance: multi-center large sample clinical verification (> 1000 cases), sensitivity 100%, specificity 100%.
Open reagent: compatible with the current mainstream fluorescence quantitative PCR instrument.
4. Product information
|
Product Number |
Product Name |
Specification |
Registration certificate number |
|
HWTS-UR033C |
Group B Streptococcus nucleic acid detection kit (Enzymatic Probe Isothermal Amplification) |
50tests/kit |
China Machinery Registration 20243400248 |
|
HWTS-EQ008 |
HWTS-1600P（4-channel ） |
China Machinery Registration 20233222059 |
|
|
HWTS-1600S（2-channel ） |
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|
HWTS-EQ009 |
Post time: Mar-07-2024