Femlab Vaginitis Test Kit - How to Use It

The FemLab Vaginitis test kit is a screening device for use in the detection of the major forms of vaginitis in vaginal fluid specimens from women concerned about their vaginal health.

Summary and Explanation of the FemLab® Vaginitis Test Kit

Vaginitis is defined 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, Candida yeast infections, Trichomoniasis, and Chlamydia trachomatis. These common forms of vaginitis 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 FemLab® test kit is an easy to use product that can accurately diagnose common types of vaginitis within a few minutes. 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 proficient 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. To use the kit, samples
of vaginal fluids are taken on sterile swabs, and are either applied to test zones on the test kit platform, or diluted in a specially designed buffer delivery system for application to the remaining test zones. The test results are evaluated by comparing the color change results for each of the six test zones to the colors on the test cassette, and then consulting the diagnosis protocol described later in this document. Each major form of Vaginitis may be accurately diagnosed by following this methodology. Treatment or recommended treatment regimens require the consultation of a medical professional. FemLab is not to be used for self-diagnosis and self-treatment.

Intended use

This test kit is intended for use in professional medical facilities by trained technicians to diagnose the common forms of vaginitis; or, in certain circumstances, under a physician’s or trained medical professional’s supervision, the kit may be prescribed for home use by any woman concerned about her vaginal health.

The FemLab vaginitis diagnostic test kit requires careful collection and application of several vaginal fluid samples. Each vaginal fluid sample must be collected as described in the sample collection directions below.
As the FemLab test kit is to be used as a screening tool, the diagnosis of any vaginitis condition will depend on the careful analysis of the FemLab results as described in this document. All final diagnostic conclusions, including medical decisions regarding patient treatments, are the responsibility of the treating medical
professional. The FemLab test kit is primarily a screening tool, and any positive results should always be

Principles of the Test

The FemLab Pro test kit has a total of seven sample application zones on the small plastic test platform. Each test zone and the color changes for each positive and negative result are described in detail in this document. The seven test zones are individual chemical and biological tests that screen for specific chemical or biological aspects of the vaginal fluid samples. These test zones can accurately differentiate between the various disease states (see Interpretation of Results later in this document). Vaginal fluid samples are collected in a three-step collection procedure; two samples are used directly on test zones, and the third is diluted in a custom designed buffer dilution and delivery system. The test results are determined by observing color changes on each test zone following sample application. The colors are compared to a color
chart on the test cassette to draw conclusions as to the results of each test. A diagnostic protocol to accurately determine the condition causing the vaginitis will be described in this document.

The diagnostic protocol detailed below, and the sample collection and application instructions must be followed closely to achieve an accurate diagnosis. Descriptions of each test zone, drawings of the test cassette and recommended methods of use are shown below:

 

Zone 1: pH Zone
The normal pH of vaginal fluid is in the range 3.8 to 4.2. After application of the test fluid sample, if the pH test
zone (zone 1) turns from pink to light blue-green within 3 minutes, the pH is above 4.7, which indicates a positive result. If the vaginal fluid is below pH 4.7, the color remains pink, indicating normal vaginal pH. The pH
zone change to a light blue-green color an abnormally high pH - is a positive finding, consistent with bacterial
vaginitis and/or trichomoniasis, microorganisms that impair the growth of the normal vaginal lactobacilli,
which keep pH low.

Zone 2a - 2b: Gardnerella Zone
An enzyme activity test specifically designed to detect the presence of Gardnerella vaginalis bacteria and a few other infectious bacteria in vaginal fluid specimens is used in Zone 2. The development of a visible peach-topink-to-red color on the test swab after application of the vaginal fluid sample onto the test zone is a positive test result, indicating the presence of Gardnerella Bacterial vaginitis. No color change on the test swab indicates there is no Gardnerella infection.

Zone 3: Nitrite Zone
This test zone depends upon the chemical conversion of nitrate to nitrite by the action of gram-negative bacteria in the vaginal fluid. If the test procedure using the buffer diluted vaginal fluid sample turns the test zone from colorless to a pink color, this is a positive reaction consistent with the presence of a yeast infection. If no color change is observed, this indicates a lack of yeast.

Zone 4: Blood Zone
A vaginal infection may result in bleeding in the vaginal cavity. After application of the buffer diluted vaginal
fluid sample onto the Blood Zone, a color change from yellow to dark green or blue is an indication of blood in the vaginal fluid. The presence of blood indicates the possibility of a Chlamydia infection or severe Bacterial
vaginitis. A confounding factor can be the presence of menstrual blood in the sample, which may result in a
false positive test. If menstrual blood may be present, this zone should be given less weight in the diagnostic
scheme.

Zone 5: Protein Zone
Application of the buffer diluted vaginal fluid sample onto the Protein Zone will result in a blue color if the
protein concentration in the vaginal fluid exceeds normal levels. A blue color, a positive reaction, is consistent with the presence of Chlamydia or Bacterial vaginitis, but also may occur with other forms of vaginitis. The infectious organisms produce pus, which will result in abnormal protein levels in the vaginal fluid.

Zone 6: Leukocyte Zone
Application of the buffer diluted vaginal fluid sample onto the leukocyte zone will result in a color change to
pink or light purple if white blood cells are present. Light purple indicates a positive result, indicating a
Trichomonas or Chlamydia infection, depending on the status of other test zones. If there is no color change, this indicates no Trichomonal or Chlamydia infections.

Package Contents and Instructions for Use
Warnings and Precautions

1. Check the expiration date printed on foil pouch and carton box. Do not use the test kit after the expiration
date.

2. Do not use the test kit if the foil pouch is not sealed, or ifthe pouch is broken.

3. Do not remove the test from foil pouch until ready to use. Once the foil pouch has been opened, the test must be used within 60 minutes.

4. To obtain accurate results, the Package Insert Instructions
for Use must be read before using the test kit, and
followed closely.

5. Do not use the vaginal fluid collection container if it is broken or the buffer is leaking out.

6. This product is intended only for vaginal fluid use. Do not touch or collect vaginal fluid near the cervix. Do not use vaginal fluid specimens that contain blood.

7. Only use the sterile tri-pack swabs included with the test kit. Do not use sterile swabs if the package is not sealed or if the seal has been broken.

8. Patient vaginal swabs are not appropriate for any other purpose, including bacterial culture, after performing the test.

9. Dispose of patient samples in biological sample disposalcontainers

10. If symptoms persist, consult a physician.

 

Test Tray and Supplies
This package contains the following items:

1. Vaginal fluid specimen container with buffer solution
2. Tri-pack Sterile Swab
3. Instructions for Use (Package Insert)
4. Test Tray

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 bestudied carefully and followed exactly to ensure accurate samplecollection and application, and therefore reliable and accurate results.

Inside the box there is intructions with pictures on it.