Instructions for Use

Warnings and Precautions

 

-       These instructions for use are not approved by the US FDA for use inside the USA.

-       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 must be used within 60 minutes.

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

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

-       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.

-       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.

-       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

-       If symptoms persist, consult a physician.

 

 

 

Test Tray and Supplies

 

This package contains the following items:

 

-       Vaginal fluid specimen container with buffer solution

-       Tri-pack Sterile Swab

-       Instructions for Use (Package Insert)

-       Test Tray

 

 

Instructions for Use

 

This test kit is intended for use by a trained medical technician, nurse, nurse practitioner, physicianÕs 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. 

 

 

 

Drawing 1 – Contents of Package

 

 

 

 

 

The package also contains this package insert and instructions for use.  Patient records are recorded on the FemLab cassette by circling each positive or negative finding on the cassette label.

 

 

 

 

Instructions for Use – Collection of Vaginal Fluid Sample

 

Open the package and identify the vaginal fluid specimen container with buffer (a), the tri-pack of three sterile swabs (b), the test tray (c) and the insert (d).

 

Wash hands thoroughly, and observe sterile technique while taking and testing vaginal fluid 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. 

 

Open the sterile tri-pack of sample collection swabs, and gently open the vaginal opening, and insert the swabs about two to three inches into the vagina.  Do not insert near the cervix, as pH results would be inaccurate. 

 

Drawing 2 – Insertion of sterile swab tri-pack into vagina

 

 

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 fluid. 

 

Remove the Vaginal fluid specimen container with buffer solution and the test cassette tray from the foil pouch.  Write the patientÕs name in the space provided on the FemLab test cassette

 

Remove the three swabs from the vagina. 

 

Rub one swab saturated with fluid sample onto Zone 1 - the pH zone – of the test tray. Discard the swab in a biological specimen container.  Read the pH color after three minutes, and note the result on the Test cassette tray next to the pH Zone Result color comparison chart.  Simply circle the color – either positive or negative – with an ink pen .

 

 

 

Drawing 3 – Application of swabs onto test Zone 1, pH Zone. 

 

 

While the pH Zone color is developing, take a second swab and rub onto Zone 2a six or seven times.  Then, immediately rub this same swab onto Zone 2b several times.   Wait 1 - 5 minutes. If the swab itself becomes peach or pink within One minute, it is a positive reading for Gardnerella.   Record the Gardnerella result on the test cassette near the Gardnerella Zone Result color comparison.

Drawing 4 – Application of swabs onto test Zone 2, Gardnerella zone

 

 

 

Finally, take the third swab, open the vaginal fluid specimen container with buffer solution, and thoroughly mix the swab into the buffer in the container.  Swirl the swab vigorously for 15 seconds, and then expunge as much liquid as possible from the swab by pressing and rotating the fiber portion against the wall of the specimen collector. Discard the swab. Insert the dropper tip securely into the specimen container opening, and then screw the cap onto both the dropper tip and the specimen container.

 

 

 

Drawing 5 – Screw the Tip and Cap onto the Specimen Container.

 

 

 

 

 

 

 

After the specimen container is tightened securely, shake vigorously up and down ten (10) times.

 

 

 

 

 

Drawing 6 –  Shake vigorously up and down ten (10) times.

 

 

 

 

 

Remove the cap.  Hold the vaginal fluid collection container above each of test zones 3 through 6, and carefully squeeze one drop onto each of test zones 3 through 6.

 

Drawing 7 - Squeeze buffer solution container and place one drop into each of zones 3 - 6.

 

 

Wait about two minutes, and then read the color results for each of the test zones 3 through 6. 

 

Promptly circle the square that most closely matches the test zone color.

 

Note: It is important to read the test results within two (2) to three (3) minutes after placing the droplets of specimen onto the test zones.

 

Discard the specimen collection container with the second and third swabs in a biological specimen container. 

 

Important Issues to Obtain Best Results

 

-       The specimen used for pH testing must be an undiluted vaginal fluid sample.

-       The specimen used for Gardnerella testing must be a separate undiluted sample.

-       The specimen used for the remaining tests must be diluted in the buffer solution container as directed. 

-       The collection of the vaginal fluid sample should be performed in a single step.

-       Ensure that nothing remains inside of vagina after collection.

-       Read the colors on the test cassette within the prescribed time of application of the sample, and circle the color result with a pen on the cassette to record the results.

 

 

 

 

 

Kit Storage

 

Store the FemLab test kit at 2-30 degrees C (35 – 86 degrees F), out of direct sunlight.

 

Quality Control

 

Each production lot of FemLab cassettes 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 from the Manufacturer 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 FemLab test cassette.

 

Limitations of the test kit

 

-       The FemLab test kit is to be used as a screening device.  Final diagnostic results should be rendered by medical professionals, who may recommend additional laboratory or medical testing to confirm any diagnosis.

-       The absence of any positive results with the FemLab test kit does not rule out the presence of vaginitis.

-       Test results may be affected by improper specimen collection, handling and procedure.

-       Mixed infections may occur.  Therefore, a test result indicating one positive result does not rule out the presence of other infectious organisms.

 

 

 

FemLab Test Kit - Diagnostic Protocol

and Interpretation of Results 

 

The major forms of Vaginitis can be determined fairly accurately by a careful analysis of the FemLab test results as recorded on the test cassette color chart.  The following diagnostic protocol will provide guidance in this process. 

 

It cannot be emphasized enough that accurate results require that the vaginal fluid sample collection methodology and test application methodology be performed according to the instructions in this document.  The diagnostic protocol will be described below in three sections:  (1) Test Zone Color Interpretation – will describe generally what the color result for each test zone means; (2) Identification of Infectious Organisms – will describe the combinations of test zone results that identify a particular organism; and (3) performance characteristics of FemLab in a controlled clinical trial.

 

 

Test Zone Color Interpretation

 

Zone 1: pH Test Zone:  A light blue-green color indicates a positive result, a pH above 4.7.  This may indicate a bacterial infection and will also be present with most cases of Tricho­monal vaginitis if Leukocytes, Zone 6, are also present. 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.

 

Zone 2: Gardnerella Test Zone:  A peach-pink color indicates a positive result.  The Gardnerella test zone (2b) and the test swab used on Zone 2 will turn peach-pink within five minutes if a Gardnerella bacterial infection is present.  A positive result specifically indicates the presence of Gardnerella bacteria.  A negative result means that Gardnerella is not present, but infections from other bacteria are not ruled out by a negative result.  

 

Zone 3: Nitrite Test Zone:  A pink color indicates a positive result.  The nitrite test zone will turn to pink if the conversion of nitrate to nitrite by the action of gram-negative bacteria in the vaginal fluid occurs. This result reliably indicates the presence of Yeast infections.

 

Zone 4: Blood Test Zone:  A dark green or blue color indicates a positive result.  The blood test zone turns from yellow to dark green if red blood cells are present in the buffer diluted vaginal sample. This is generally indicative of the presence of Chlamydia bacteria, if Leukocytes are also present, but may also be present with other bacterial or yeast infections.  If both zone 4 and zone 6 are positive (blood and leukocytes), this is indicative of a Chlamydia infection, caused by the bacterium Chlamydia. Menstrual blood in the sample may result in a false positive test. If menstrual blood is suspected, less weight should be given to the blood zone. .

 

Zone 5: Protein Test Zone:  A blue color indicates a positive result.  The protein test zone will turn to blue if the buffer diluted vaginal fluid sample contains protein in excess of normal values.  A positive result is associated with bacterial, yeast, Chlamydia and Trichomonal infections.  Serious occurrences of these infections will produce pus which shows up as positive protein in the protein test zone.  A negative protein zone result is associated with the absence or low levels of these infectious organisms.

 

Zone 6: Leukocytes Test Zone:  A light purple color indicates a positive result.  The Leukocyte test zone, initially colorless, turns to light purple with application of the diluted vaginal fluid specimen if white blood cells are present in the sample.  A positive result indicates the presence of Trichomonas parasites or Chlamydia infection. If both leukocyte and blood tests are positive (zones 4 and 6), it is likely that Chlamydia is present. If both leukocyte and pH tests are positive (zones 1 and 6), it is likely that Trichomonas is present.  A negative leukocyte zone result indicates the absence or very low levels of Trichomonas or Chlamydia.

 

Identification of Infectious Organisms

 

The following two tables (Table I and Table II) summarize the interpretation method for the FemLab test kit. 

 

To use the Diagnostic Protocol in Table I and Table II below, compare the test zone color results on the FemLab Test Kit to the test zones on the Tables. 

 

The cells in Table I indicate the general positive and negative interpretations for each Zone color result.  Use this information to evaluate the possible disease states diagnosed by the FemLab cassette results

 

Table II shows the expected result for the four main pathogenic organisms that are causes of vaginitis.  Compare the actual FemLab test cassette color results to the positive and negative cells on Table II.  If a specific  combination of zones on the test kit match those in Table II, the corresponding disease organism is correctly identified. If specific test zones on the FemLab cassette are negative and the corresponding cells in Table II are positive, then that disease organism is not present.  If the zones for a particular organism match, and other zones also match another organism, then this is a multiple diagnosis, and multiple organisms are present. 

 

 

Table I

FemLab Test Kit - Test Zone Interpretation Table

 

Test Result ___________   Test Zone	Positive Color	Negative Color	Positive Result Interpretation	Negative Result Interpretation
pH Zone 1	Blue-green	Pink	Bacterial Vaginitis and/or Trichomonas	No or low level bacterial infection.  Trichomonas still possible
Gardnerella Zone 2	Pink	No color	Bacterial Vaginitis and/or Gardnerella	No Gardnerella infection
Nitrite Zone 3	Pink	No color	Yeast infection.	No or low level yeast or bacterial infection
Blood Zone 4	Blue	Yellow	Chlamydia infection if Leukocyte (Zone 6) also positive. Bacterial infection if pH (Zone 1) also positive	No Chlamydia Infection
Protein  Zone 5	Blue	Light Yellow-green	Bacterial, Chlamydia, Yeast or Trichomonas infections, associated with severity	No color change suggests only moderate infections of any types
Leukocytes Zone 6	Pink-purple	No color	Trichomonas infection if pH (Zone 1) also positive.  Chlamydia infection if blood (Zone 4) also positive.	No color change indicates patient has no Trichomonal or Chlamydia infection.

 

 

 

 

 

 

Table II - FemLab Test Kit Diagnostic Conclusions

 

Test Zone ____________   Diagnosis	Zone 1 pH	Zone 2 Gardnerella	Zone 3 Nitrite	Zone 4 Blood	Zone 5 Protein	Zone 6 Leukocytes
Bacterial Vaginitis	Positive	Positive or Negative	Negative	Negative (or Positive, severe Bacterial Vaginitis)	Negative (or Positive, severe Bacterial Vaginitis)	Negative
Chlamydia Vaginitis	Negative	Negative	Negative	Positive	Positive or Negative	Positive
Yeast Vaginitis	Negative	Negative	Positive	Negative or Positive (severe Yeast Vaginitis)	Negative	Negative
Trichomonal Vaginitis	Positive (or Negative, light Trichomonal Vaginitis)	Negative	Negative	Negative	Positive or Negative	Positive
Healthy	Negative	Negative	Negative	Negative or Positive (during menstrual period)	Negative	Negative