Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
gima@gimaitaly.com - export@gimaitaly.com
PROFESSIONAL MEDICAL PRODUCTS
www.gimaitaly.com
VAGINAL PH TEST
PROFESSIONAL USE
User manual
ATTENTION: The operators must carefully read and completely
understand the present manual before using the product.
The Vaginal pH test kit is a screening device for use in the detection of the
major form of vaginitis in vaginal uid specimens from women concerned
about their vaginal health.
Summary and Explanation of the Test Kit
Vaginitis is dened as irritation of the vagina, a troublesome condition that
affects millions of women of all ages in all parts of the world. The most
common types of vaginitis are Bacterial vaginitis, etc. It can usually be
treated effectively with prescription or over-the-counter medication if correctly diagnosed. However, if left untreated, misdiagnosed or incorrectly
treated, vaginitis can produce serious consequences such as sterility or
miscarriage, and it can be a precursor to cancer.
The test kit is intended to be used by or under the direction of a trained
medical professional. The test kit is very easy to use and only minimal
training is necessary for staff level technicians to become procient in the
accurate diagnosis of vaginitis in any particular case. Such trained professionals can also easily instruct or assist patients with the use of the kit
on their own. Treatment or recommended treatment regimens require the
consultation of a medical professional. Vaginal pH test is not to be used
for selfdiagnosis and self-treatment.
Intended use
The Vaginal pH test kit will be used only on site in physician’s ofces, clinics, and hospital or professional laboratories – point of care sites - where
women will visit in person to have the test performed. The test kit procedures may be performed only by trained medical professionals who have
carefully read, and understand, the Instructions for Use. Samples must be
tested on site, and may not be transported for testing in remote locations.
Principles of the Test
There is a link between vaginal health and pH. Fluctuations in vaginal pH
are often normal occurrences resulting from variations during the menstrual cycle, a decrease in pH during pregnancy, or the presence of seminal uid, blood, amniotic uid, or cervical mucus. However, an abnormal
pH level may also indicate the presence of a vaginal infection, such as BV.
pH Zone Color
The normal pH of vaginal uid is in the range 3.8 – 4.2. After application of
the test uid sample, if the pH test zone turns from pink to grayish purple
or blue-green 1 minute, the pH is above 4.7, which indicates a positive result. If the vaginal uid is below pH 4.7, the color remains pink, indicating
normal vaginal pH. The pH zone change to grayish purple or bluish green
– an abnormally high pH - is a positive nding, consistent with bacterial
vaginitis and/or trichomoniasis, microorganisms that impair the growth of
the normal vaginal lactobacilli, which keep pH low.
Warnings and Precautions
• Check the expiration date printed on foil pouch and carton box. Do not
use the test kit after the expiration date.
• Do not use the test kit if the foil pouch is not sealed, or if the pouch is
broken.
• Do not remove the test from foil pouch until ready to use. Once the foil
pouch has been opened, the test strip must be used within 10 minutes.
• To obtain accurate results, the Package Insert Instructions for Use must
be read before using the test kit, and followed closely.
• This product is intended only for vaginal uid use. Do not touch or collect vaginal uid near the cervix. Do not use vaginal uid specimens that
contain blood.
• Do not use sterile swabs if the package is not sealed or if the seal has
been broken.
• Patient vaginal swabs are not appropriate for any other purpose, including bacterial culture, after performing the test.
• Dispose of patient samples in biological sample disposal containers.
Instructions for Use
This test kit is intended for use by a trained medical technician, nurse,
nurse practitioner, physician’s assistant, or physician, or by a patient under the guidance of one of these trained medical practitioners. The instructions for use shown below should be studied carefully and followed
exactly to ensure accurate sample collection and application, and therefore reliable and accurate results.
Collection of Vaginal Fluid Sample
Wash hands thoroughly, and observe sterile technique while taking and
testing vaginal uid samples.
First, thoroughly swab the inner and outer labia of the patient with a sterile
wipe to reduce the exterior bacterial count from the vaginal opening.
Insert the swabs about two to three inches into the vagina. Do not insert
near the cervix, as pH results would be inaccurate.
Drawing 1– Insertion of sterile swab into vagina
In a healthy vagina, lactobacilli—the main determinant of pH—are instrumental in maintaining vaginal acidity (normal pH is 3.8 to 4.2), and preventing the overgrowth of other aerobic and anaerobic bacteria. In BV,
the pH is elevated in association with an increase in microorganisms that
impair the growth of lactobacilli. Because of the critical role pH plays in
suppressing the growth of BV-associated bacteria, an increased vaginal
pH is an important indicator in diagnosing BV.
Most physicians accept the criteria of pH > 4.5 or ≥ 4.7 as one indicator
of BV. Regardless of the level used, if a higher than normal vaginal pH is
detected, other diagnostic tests should be performed to investigate the
presence of BV or other infections.
In order to ensure the accuracy of the pH test, obtaining a reliable vaginal
uid sample is essential. A specimen, should be collected from the anterior fornix or lateral vaginal wall. It is important that contact with the cervix
is avoided because cervical pH is higher than vaginal pH.
Gently stroke the inner walls of the vagina with the swabs, ensuring that
the swabs are all moistened thoroughly. Leave the swabs in the vagina
several minutes to ensure they are saturated with vaginal uid.
Remove the swab from the vagina.
Rub the swab saturated with uid sample onto the pH zone.
Discard the swab in a biological specimen container. Read the pH color
after 1 minute, and compare the result with the color chart.
Drawing 2 – Application of swab onto pH Zone.
Graphical Symbos Used
MAX
Store between
30°C
MIN
2°C
2° and 30°C
Expiration date
Quality Control
Each production lot of Vaginal pH test strips is tested rigorously at the
factory before packaging and shipping, with both positive and negative
control reagents. Positive and negative control reagent kits are available if
a clinic or pharmacy wishes to conduct in house control procedures. The
positive and negative control reagents are designed to produce the color
changes expected for positive or negative results on the Vaginal pH test
cassette.
Kit Storage
Store the Vaginal pH test kit at 2-30 degrees C (35 - 86 degrees F), out of
direct sunlight.
Interpretation of Results from the Viginal pH Test Kit
It cannot be emphasized enough that accurate results require that the
vaginal uid sample collection methodology and test application methodology be performed according to the instructions in this document.
Test Zone Color Interpretation
A grayish purple or bluish green color indicates a positive result, a pH
above 4.7. This may indicate a bacterial infection. No color change indicates a pH below 4.7, which is normal for the vagina. This indicates the
absence or very low level of bacterial infection or Trichomoniasis.
In vitro diagnostic
medical device
Product code
Consult instructions
for use
Disposable device,
do not re-use
Authorized representative in the European
community
In vitro diagnostic
medical device
complies with
Directive 98/79 / EC
Don’t use if package
is damaged
Lot number
Contains sufcient
Σ
for “n” tests
1
Manufacturer
Caution: read instructions (warnings)
carefully
Keep in a cool,
dry place
Keep away
from sunlight
Sterilized using
ethylene oxide
Test Result
Test Zone
pH
Zone 1
Positive
Color
Grayish
purple
to bluish
green
Negative Color
Positive
Result
Interpretation
Pink Bacterial Va-
ginitis and/or
Trichomonas
Negative
Result
Interpretation
No or low
level bacterial
infection.
Trichomonas
still possible
References
Andersch B, Lindell D, Dahlen I, Brandberg A. Bacterial vaginosis and the
effect of intermittent prophylactic treatment with an acid lactate gel.
Gynecol Obstet Invest. 1990;30:114-119.
Barrington JW, Linton D, O”Leary A, et al. Anaerobic (bacterial) vaginosis
and premalignant disease of the cervix. J Obstet Gynaecol 1997;17:383-
385.
Borchardt KA, Al-Haraci S, Maida N. Prevalence of Trichomonas vaginalis
in a male sexually transmitted disease clinic population by interview, wet
mount microscopy and the InPouch TV test. Genitourin Med 1995;71:405-
406.
Platz-Christensen JJ, Sundstrom E, Larsson P-G. Bacterial vaginosis and cervical intraepithelial neoplasia. Acta Obstet Gynecol Scand
1994;73:586- 588.
Cohen CR, Duerr A, Pruithithada N, Rugpao S, Hillier S, et al. Bacterial
vaginosis and HIV seroprevalence among female commercial sex workers
in Chiang Mai, Thailand. AIDS 1995;9:1093-1097.
29110 / V03-01
Ameritech Diagnostic Reagent Co., Ltd
K4-2 Science Technology Garden,
Economic Development Zone, Tongxiang, ZJ, China
Made in China
CEpartner4U BV,
Esdoornlaan 13, 3951DB Maarn, The Netherlands
FOR PROFESSIONAL USE
30°C
2°C
Swab
Zhejiang Gongdong Medical Technology Co., Ltd.
NO.10 Beyuan Ave., Huangyan, 318020
Taizhou, Zhejiang, China
Made in China
Shanghai International Holding Corp. GmbH (Europe)
Eiffestrasse 80, 20537 Hamburg, Germany
0123
M29110-GB-Rev.2-03.20
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