For health and medical care personnel
VagiVital
Diagnoses - Treats - Prevents
For ordering bulk packs, samples or information email:
fanny.falkman-grinndal@peptonicmedical.se
VagiVital AL Self-test for amniotic fluid leakage
VagiVital AL Self-test is a patented Swedish method for detecting amniotic fluid leakage. The test consists of a panty liner with a patented film that detects pH and ammonia levels in fluid. The polymer-embedded film changes color from yellow to blue or green even with very small amounts of amniotic fluid. When the liner feels wet, it is removed and the result is read after 15 minutes. In case of urine leakage, the liner remains yellow.
Clinical studies show:
- Sensitivity 97.06%
- Specificity 96.92%
- PPV 96.92%
- NPV 97.67%
An independent calculation performed by the External Assessment Centre (EAC) based on three studies of VagiVital AL shows a sensitivity of 97%, specificity of 79%, and PPV of 96%. The proportion of false negative tests at 3-4% was assessed to be at the same level as the proportion of false negative vaginal examinations with sterile instruments; 3.8 – 3.9%
“Since the method is non-invasive and easy to use and interpret, it would VagiVital® AL can be used at midwife clinics to screen for water breaking when pregnant women seek care for unclear leakage. In this way, only those with a positive test would need to be sent to the hospital for examination and further management. VagiVital® AL could also be used in delivery wards where so little water leaks or in intermittent leakage that a regular vaginal examination does not detect water breaking”, says Rebecka Kaplan Sturk, senior consultant gynecology/obstetrics
Read Rebecka Kaplan Sturk, senior consultant gynecology/obstetrics, analysis of VagiVital AL Self-test for amniotic fluid leakwith its possible applications at midwife clinics and delivery wards here.
FREQUENTLY ASKED QUESTIONS
Answer: The test strip in the pad acts as a pH indicator and changes color to blue and/or green upon contact with fluid with a pH ≥ 6.5. Amniotic fluid has a high pH above 6.5. The test strip reacts to the ammonia level in the fluid. If there is a high level of ammonia present, the color returns to yellow as the ammonia evaporates. Therefore, it is important to wait the full 15 minutes after the pad has been removed before interpreting the final result.
Answer: The VagiVital AL pad has the ability to detect even a small volume of amniotic fluid over an extended period (up to 12 hours per pad), allowing for continuous monitoring and can therefore help avoid misdiagnosis of amniotic fluid leakage. VagiVital AL for Amniotic Fluid Leakage is a non-invasive alternative to other detection methods, with rapid results (in just 15 minutes) and high sensitivity of 97.06% and specificity of 96.92%. No sterile instruments or examination rooms are required. VagiVital AL can also be used at midwife clinics to screen for water breaking when pregnant women seek care for unclear leakage or dampness in their underwear. The AL pad can also be used in delivery wards in situations where so little water leaks or the leakage is so intermittent that a regular vaginal examination does not detect water breaking. The pregnant woman can then take a pad home and be instructed to contact if it changes to blue and/or green.
After amniotic fluid sampling for prenatal diagnosis, amniotic fluid leakage is very common. The AL pad can in these situations be used to detect when amniotic fluid leakage has stopped and the pregnant woman can begin to move and live normally again.
Answer: Antibiotic treatment or vaginal infections (such as bacterial vaginosis) can lead to an elevated vaginal pH, which can result in a false positive test result for the presence of amniotic fluid. Tap water can interfere with the test and may give a false positive result - therefore users are advised to ensure they are completely dry if they have recently showered or bathed. If intercourse or vaginal douching has occurred within the last 12 hours, this can also interfere with the test.
Answer: VagiVital AL for Amniotic Fluid Leakage has:
Sensitivity 97.06%
Specificity 96.92%
Positive predictive value 96.92%
Negative predictive value 97.67%
Answer: VagiVital AL for Amniotic Fluid Leakage is designed for self-reading. If the indicator strip turns blue and/or green, amniotic fluid may have leaked. In this case, the pregnant woman should contact her doctor/midwife. If the user intends to show the test result to her doctor/midwife and consult, she should bring the pad to the doctor.
Answer: Blood causes a red stain on the pad. If the blood is mixed with amniotic fluid, a positive blue stain may appear around the surface of the red blood stain. The package insert states that a doctor/midwife should be contacted if bleeding occurs.
Answer: 100µL (microliters)
Answer: Infections that cause elevated vaginal pH (e.g. bacterial vaginosis and trichomonas), semen, urine with pH > 7.0. That the method signals water leakage in bacterial vaginosis and the pregnant woman is referred to the hospital for monitoring does not have to be negative, and the pregnant woman needs treatment for bacterial vaginosis to reduce the risk of complications.
Answer: A false negative result can occur when amniotic fluid has not come into contact with the pad's yellow indicator. This can happen if the test was done while the patient was lying down. It is stated in the package insert that the test should be done while the patient is standing, sitting, or walking, but not when she is lying down.
Another cause of false negative results is if amniotic fluid leaks onto the pad and if urine leaks onto the exact same spot on the pad, which then cancels out the color change; note that this depends on the ratio between the volumes of amniotic fluid and urine.
Answer: For bulk orders, samples or information contact:
VagiVital VS Self-test for vaginal infections
How does VagiVital VS work?
The VagiVital VS test consists of a vaginal swab coated with an innovative patented polymer containing the colorimetric pH indicator, Nitrazine Yellow. When the polymer, which is yellow before use, comes into contact with fluids with elevated pH levels, the user observes a blue or green spot on the yellow indicator. What makes the sensitivity much higher than pure pH tests is that VagiVital VS also takes into account the buffering capacity of the discharge. VagiVital VS is a Swedish method that is patented. The reading can be done within just a few seconds, making it very practical to use both at the clinic and for the patient at home.
Vagivital VS pH threshold:
- pH ≤ 4.2 the swab tip remains yellow
- pH ≥ 5.2 the swab tip colors blue or green
- 5.2 > pH > 4.2 the swab tip colors blue or green only if the buffering capacity in the discharge is low (the combination of measuring both pH and buffering capacity increases sensitivity to over 90%)
For bulk orders and/or more information email:
fanny.falkman-grinndal@peptonicmedical.se
FREQUENTLY ASKED QUESTIONS
Answer: No, the results are yes or no.
Answer: No, VagiVital VS PRO is certified as an OTC medical product.
Answer: VagiVital VS can help you detect bacterial vaginosis or trichomonas without the need for a microscope, potassium hydroxide, etc. In cases of multiple vaginal mixed infections, the test offers assistance in diagnosing infection despite the dominant symptoms from Candida. At the end of treatment, you can also examine the effectiveness of bacterial vaginosis or trichomonas treatments. A shortage of gynecologists and simultaneously new over-the-counter products also open up both the need and opportunity for midwives to have a greater role in diagnosis and treatment at youth clinics and midwife clinics.
Answer: In a Candida infection, the pH value in the vaginal discharge remains normal. Therefore, the indicator strip will not change color.
Answer: Our clinical studies show that self-reading is possible. If the user is pregnant and the indicator strip colors blue and/or green (the color may indicate amniotic fluid leakage), it is important to consult a doctor.
Answer: It is recommended to postpone the test if: (1) it is less than 1 day before or 5 days after the patient’s menstruation; (2) if the woman has any signs of menstruation or vaginal bleeding; (3) it is less than 12 hours after intercourse or vaginal douching; or (4) during or after menopause.
Answer: Laboratory tests are expensive, time-consuming, and may require a second clinic visit. VagiVital VS PRO has more than 92% accuracy, which is slightly lower than laboratory tests but much more efficient in terms of time, cost, and accessibility.
Answer: Yes, but since a positive result can also be due to amniotic fluid leakage, it is recommended that pregnant women consult their doctor before using the test, as interpreting test results during pregnancy requires professional knowledge.
Answer: It is recommended to wait to use the product during menstruation because the vaginal pH level is higher and can cause false positive results.
Answer: At pH ≤ 4.7, VagiVital VS PRO does not change the color of the indicator tip; at pH > 4.7, the indicator tip changes color. VagiVital VS pH threshold:
- pH ≤ 4.2 the swab tip remains yellow
- pH ≥ 5.2 the swab tip colors blue or green
- 5.2 > pH > 4.2 the swab tip colors blue or green only if the buffering capacity in the discharge is low (the combination of measuring both pH and buffering capacity increases sensitivity to over 90%)
Answer: A positive test (color change from yellow to blue or green) indicates an acidity disturbance in vaginal secretions, often caused by bacterial vaginosis and trichomonas. The test has 92% accuracy because it measures not only pH but also the buffering capacity in the discharge. Bacterial vaginosis appears as a thin, milky, white-gray discharge with a fishy odor. Discharge caused by trichomonas is yellow-green, foamy, and foul-smelling and may cause itching of the vulva and pain during urination. In both infections, the vaginal pH is elevated. However, the pH value in the vagina is usually normal in yeast infections. If the swab tip has not changed color after 10 seconds, the result shows that the vaginal pH is normal. The likelihood that you then have a bacterial or trichomonas infection is low.
On the back of the box, see image in the attached file, there is a summary table that details symptoms associated with vaginal bacterial, trichomonas, or fungal infections.
VagiVital ActiveGel for vaginal dryness and pain during intercourse
VagiVital is a hormone-free active gel that relieves and cures symptoms in the intimate area such as dryness, irritation or itching in the intimate area, discomfort during intimate contact, or pain during urination.
The crystal-clear gel releases water to the mucous membrane over time, restores pH, and stimulates the growth of cells in the mucous membrane's surface layer. The basis for the good results with VagiVital ActiveGel is its physiological properties. The gel has a high viscosity, low osmolality, and low surface tension. These properties combined make the gel adhere to the vaginal mucosa and release water over time. The gel contains no fats, which means it does not feel sticky, and the included applicator is easy to clean with just hot water. Important user-friendly advantages to add to the documented positive clinical effects.
VagiVital has undergone clinical tests in a study conducted by female researchers at Karolinska University Hospital, Akademiska Hospital in Uppsala, and Norrland University Hospital. The clinical study showed several positive effects where as many as 79% of patients experienced an improvement in their most troublesome symptoms. This has led to VagiVital being classified as an active gel, as the gel's clinically proven effects do more than just moisturize.
The following improvements were documented:
- Reduced symptoms of dry mucous membranes (itching, irritation, pain during intimate contact, and pain during urination).
- Reduced symptoms of urge incontinence.
- Improvement of pHi in the intimate area and the number of cells in the mucous membrane's surface layer.
- The effects of VagiVital on the most troublesome symptoms are at the same level as estrogen preparations, with the big difference that VagiVital is completely hormone-free.
- The study was conducted in accordance with FDA guidelines.
VagiVital Moisturizing V Cleanser
The product is based on VagiVital's active gel and mild rapeseed oil with a low pH value of 3.9. It is free from soap, perfume, and parabens and is suitable for sensitive skin. VagiVital Moisturizing V Cleanser is emollient and moisturizes while dissolving both fat-soluble and water-soluble impurities without disturbing the natural pH balance. With a water-based gel that stabilizes oil, cleaning of both water-soluble and oil-soluble impurities is enabled. This is without added surfactants. This property has allowed VagiVital Moisturizing V Cleanser to meet international patent requirements and it will be patented.