Non-invasive test for continuous monitoring of amniotic fluid losses

PRESENTATION AND METHOD OF USE
In vitro test for self-monitoring, in the form of an absorbent with a light yellow indicator strip
It is applied in the same way as a normal absorbent
The straw-yellow indicator strip is positioned next to the vagina
It is recommended that the patient wear the absorbent when sitting, standing or walking, not when lying down
It can be worn for up to 12 hours

When the patient feels the sensation of leakage, wait 10 minutes, then examine the yellow indicator strip of the absorbent

INTERPRETATION OF THE RESULTS 1
Color change
blue or green
regardless of intensity
partial or complete
regardless of size, shape or location

INTERPRETATION OF THE RESULTS 2
How?
Simple test, based on the color change of the polymer containing nitrazine
blue-Suggestive of amniotic fluid. It is recommended to consult a doctor
yellow-Indicates the presence of urine. No need to consult a doctor

Why?
Normal vaginal pH
=4.5-5.5
Amniotic fluid pH ≥6.5
At values ​​≥ 6.5, the color of the indicator strip changes

INTERPRETATION OF THE RESULTS 3
URINE
The indicator strip is sensitive to vaginal fluid. In the case of urine contamination (which has a pH of 5.5-7), the test will be negative

Why?
The return of the color to yellow (reversible reaction) is determined by the decomposition of basic conjugated molecules under the action of ammonium ions from the urine
The higher the concentration of ammonium ions in the tested fluid, the more they attach to more nitrazine molecules, and the blue color disappears

FACTORS THAT MAY INTERFERE WITH THE RESULTS
Water
Before applying the absorbent, it is recommended to dry the hands after washing
Vaginal washing
Water or products used
Testing after 12 hours is recommended
The sexual act
Seminal fluid
Testing after 12 hours is recommended
Vaginal bleeding
If there is also amniotic fluid, it is possible that a blue ring may appear around the blood spot
It is recommended to consult a doctor
Bacterial vaginal infections or trichomoniasis
Increase intravaginal pH
Candida infection does not affect the test
It is recommended to consult a doctor
Antibiotic treatment
Increases vaginal or urinary pH

AL-SENSE – ADVANTAGES
Non-invasive test
Simple:
Immediate result by examining the indicator strip
The interpretation of the results does not require the color scale
Convenient:
Self-test for use at home
Performer:
The color remains stable for at least 12 hours
Detects even minimal amounts of amniotic fluid (>100 µl = 0.1 ml)
It allows continuous monitoring, including intermittent losses of amniotic fluid
It allows differential diagnosis with urinary incontinence

AL-SENSE – PERFORMANCE
Sensitivity:
"Between 95.7% and 100%1,2
Specificity:
" 86.81%
Positive predictive value:
" 89.3%
Negative predictive value:
" 94.7%
Accuracy:
" 91.6%

CLINICALLY PROVEN EFFECTIVENESS
Multicenter, open study, in 339 pregnant women (18-45 years old), with a pregnancy of at least 16 weeks. and unidentified fluid losses
Rating:
Gynecologist, patient
Comparison (blind) with standard clinical methods (vaginal examination, vaginal pH or crystallization test)
Results:
Sensitivity 96.65% (positive result in 154/161 patients) "
Specificity 84.46% (negative result in 125/148 patients) "
Positive predictive value: 89.3%
Negative predictive value: 94.7%
Concordance between doctor and patient interpretations: 97.4%

CLINICALLY PROVEN EFFECTIVENESS
Conclusions:
AL-SENSE is a highly sensitive, non-invasive, reliable test for detecting amniotic fluid losses
False-positive results can appear in patients with bacterial vaginitis or trichomoniasis
These conditions require a medical consultation to determine the therapeutic behavior
AL-SENSE is suitable for outpatient use, the results being easy to read and interpret

CLINICALLY PROVEN EFFECTIVENESS
103 full-term pregnant women, divided into 3 groups:
With vaginal fluid losses that have not been clinically examined
With diagnosis of RPM
Pregnant without loss of vaginal fluid
Method:
The results of the AL-SENSE test were compared with the standard clinical diagnosis (vaginal examination, crystallization on the slide, vaginal pH)
Results:
100% sensitivity
Specificity 75%
Agreement between the doctor and the patient in the interpretation of the result 82.35%
Conclusions:
AL-SENSE is effective in diagnosing RPM
It allows differential diagnosis with urinary incontinence and vulvo-vaginal candidiasis

Prospective study in 139 pregnant women (median gestational age 37 weeks) with suspected RPM in the antecedents
Method
AL-SENSE test result confirmed by valve examination (blind)
Results:
Prevalence of spontaneous rupture of membranes = 42% (59/139 patients)
AL-SENSE test sensitivity 98% (58/59)
Specificity 65% ​​(52/80)
Negative predictive value 98.1%
Conclusions:
The negative test supports the diagnosis of intact membranes
Using the AL-SENSE test before the valve examination can reduce the number of examinations, with benefits for the woman and the doctor

49 amniotic fluid samples (100 and 400 µl) collected during amniocentesis (16-23 weeks of pregnancy)
Apply to the test
Reading the results: at 0 and 5 minutes, then at 10-minute intervals (the first 30 minutes), at 1, 2, 6, 12 hours
Results:
100% of cases both samples produced a color change (from yellow to blue)
The color change appeared after 5 minutes and remained stable for 12 hours
Conclusion:
AL-SENSE is a reliable, stable test for the detection of amniotic fluid losses in the second trimester of pregnancy (for example, after amnicentesis)

Presentation:
3 pieces