Gima VAGINITIS TEST KIT User guide

PROFESSIONAL MEDICAL PRODUCTS

Gima S.p.A.

Via Marconi, 1 - 20060 Gessate (MI) Italy
[e-mail] - [e-mail]

www.gimaitaly.com

TEST VAGINITE FEMLAB

®

FEMLAB® VAGINITIS TEST KIT

Uso Professionale
Professional Use

Manuale d’uso - User manual

ATTENZIONE: Gli operatori devono leggere e capire
completamente questo manuale prima di utilizzare il prodotto.
ATTENTION: The operators must carefully read and completely
understand the present manual before using the product.

29111 / V02-512

Ameritech Diagnostic Reagent Co., Ltd
K4-2 Science Technology Garden,
Economic Development Zone, Tongxiang, ZJ, China

PER USO PROFESSIONALE
FOR PROFESSIONAL USE

Tampone/Swab:

Dalian Rongbang Medical Healthy Devices Co., Ltd.
Maoyingzi Hamlet, Dalianwan Town, Ganjingzi District,
Dalian 116113, P.R. China

M-29111-IT-GB-Rev.4.03.18

CEpartner4U BV,
Esdoornlaan 13, 3951DB Maarn, The Netherlands

Lotus Global Co., Ltd
1 Four Season Terrace West Drayton,
Middlesex London, UB7 9GG
United Kingdom

30°C

2°C

0197

11

FEMLAB® VAGINITIS TEST KIT

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

SUMMARY AND EXPLANATION OF THE FEMLAB VAGINITIS TEST KIT

V aginitis is defined as ir ritation 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 various types of vaginitis will be discussed in detail in a later section of this package insert.
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. T o 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.

12

INTENDED USE

The FemLab test kit will be used only on site in physician's offices, 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. The FemLab test kit may not be used at a pharmacy , unless the pharmacy is
also a professional laboratory or other point of care site, where women visit in person to have the test
performed by a medical professional who has been trained in the use of the test kit. Samples may not be
transported for testing in remote locations. 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 f inal 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 referred to a clinician for further evaluation and for treatment.

PRINCIPLES OF THE TEST

The FemLab 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 - 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-to-pink-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.

13

ZONE 4: BLOOD ZONE

A vaginal infection may result in bleeding in the vaginal cavity. After application of the buf fer 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 le vels. A blue color, a positi ve 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

· 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.

· T o obtain accurate results, the Package Insert Instructions for Use must be r ead 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.

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 T ray

INSTRUCIONS 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

14

sample collection and application, and therefore reliable and accurate results.

Drawing 1 - Contents of Package

a) Vaginal Fluid Specimen Container with Buffer Solution
b) Sterile Swab with Sterilized Handle in Sterile Packet
c) T est Tray
d) Opuscolo.
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.

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.

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 V aginal fluid specimen container with b uffer solution and
the test cassette tray from the foil pouch. Write the patient's 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 T est
cassette tray next to the pH Zone Result color comparison chart. Simply
circle the color - either positive or negative - with an ink pen.

Drawing 2 - Insertion of sterile

swab tri-pack into vagina

Drawing 3 – Application of swabs

onto test Zone 1, pH Zone.

15

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 thir d swab, open the vaginal fluid specimen container with b uffer
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 . Screw the tip securely into the specimen container (a).
Then screw the cap onto the specimen container (a).

Drawing 5 - Screw the Tip and Cap

onto the Specimen Container .

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

Drawing 6- Shake vigorously up

and down ten (10) times.

Squeeze the vaginal fluid collection container device above each of test zones 3
through 6. Use one drop on each of test zones 3 through 6.

Drawing 7 - Squeeze buffer solution and

place the droplets into zones 3 - 6.

W ait 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.

16

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

IMPORTANT ISSUES TO OBTAIN BEST RESULTS

a) The specimen used for pH testing must be an undiluted vaginal fluid sample.
b) The specimen used for Gardnerella testing must be a separate undiluted sample.
c) The specimen used for the remaining tests must be diluted in the buffer solution container as directed.
d) The collection of the vaginal fluid sample should be performed in a single step.
e) Ensure that nothing remains inside of vagina after collection.
f) 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.

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.

KIT STORAGE

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

INTERFERENCE ANALYSIS

Potentially interfering chemical such as self-medication, Spermicide, Iodine and douches that commonly
available in over the counter of drug store were supplemented to negative and positive vagina fluid. Then
we apply such mixed solution on FemLab T est Kit to run analysis of interference. Each chemical had 20
run. The results of studies are summarized as following;

Negative Test

muissatoPenidoI

dnarBdiAetiRdnarBdiAetiR

dnarBdiAetiRdnarBdiAetiR

dnarBdiAetiR

dnarBdiAetiRdnarBdiAetiR

dnarBdiAetiRdnarBdiAetiR

dnarBdiAetiR

edicimrepS

dnarBdiAetiRdnarBdiAetiR

dnarBdiAetiRdnarBdiAetiR

dnarBdiAetiR

erutcniTenidoIdeziroloceD

ehcuoDelbasopsiD

anigaVevitageNanigaVevitageN

anigaVevitageNanigaVevitageNanigaVevitisoPanigaVevitisoP

anigaVevitageN

-----+++++

-----+++++

-----+++++

Positive Test

anigaVevitisoPanigaVevitisoP

anigaVevitisoP

It may be concluded from this analysis that none of self-medication in above Table interfered with the
ability of FemLab to correctly analyze both positive and negative control samples. Both the normal
(negative) sample and the positive control test solution were correctly diagnosed with FemLab irrespective
of the presence of the potentially self-medication.

CROSS REACTIVE ANALYSIS

The ability of the FemLab Test Kit to specif ically detect various vaginal infection were challenged through
cross reaction studies on indigenous flora to vaginal cavity such as Staphylococcus aureus, Lactobacillus
spp and Group B Streptococcus that may be potential cross reacting with FemLab device. The specificity
study was done at laboratory. Negative and positive vaginal fluid samples were spike with above
microorganisms then run a test on. These samples were tested on the FemLab T est Kit. Each microor ganism
had 10 run. T otal 30 test results are summarized into the following table.

17

Negative Test

sueruAsuccocolyhpatS

.ppssullicabotcaL

succocotpertSBpuorG

The results show none of above microorganisms had cross reacti vity with FemLa b Test Kits. In-vitro,
those microorganisms should not have cross reaction with device.

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.

· T est 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.

INTERPRETATION OF RESULTS FROM THE FEMLAB TEST KIT

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) T est Zone Color Interp retation ­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)
issues of interpretation important to accurate diagnoses.

anigaVevitageNanigaVevitageN

anigaVevitageNanigaVevitageNanigaVevitisoPanigaVevitisoP

anigaVevitageN

Positive Test

-----+++++

-----+++++

-----+++++

anigaVevitisoPanigaVevitisoP

anigaVevitisoP

TEST ZONE COLOR INTERPRETATION

Zone 1 - pH Test Zone: A light blue-green color indicates a positive result, a pH above 4.7. This ma y

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 positiv e 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 T est Zone: A pink color indicates a positiv e 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

18

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 negati ve
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 T richomonas 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 (T able I and T able II) summarize the interpretation method for the FemLab test kit.
T o use the Diagnostic Protocol in T ables I and II below , compare the test zone color results on the FemLab
T est Kit to the test zones on the Tables.
The cells in T able I indicate the general positiv e and negativ e interpretations for each Zone color result.
Use this information to evaluate the possible disease states diagnosed by the FemLab cassette results
T able II sho ws the expected result for the four main pathogenic or g anisms that are causes of v aginitis.
Compare the actual FemLab test cassette color results to the positive and negati ve cells on T able II. If any
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 T able II are positiv e, then that disease organism is not present. If the zones for a particular or ganism
match, and other zones also match another organism, then this is a multiple diagnosis, and multiple
organisms are present.

T able I - FemLab T est Kit T est Zone Interpretation T able

tluseRtseTtluseRtseT

tluseRtseTtluseRtseTroloCevitisoProloCevitisoP

tluseRtseT

1enoZHpneerg-eulBkniP

2enoZallerendraGkniProlocoNallerendraGro/dnasitinigaVlairetcaBnoitcefniallerendraGoN

3enoZetirtiNkniProlocoN.noitcefnitsaeY

4enoZdoolBeulBwolleY

5enoZnietorPeulB

6enoZsetycokueLelprup-kniProlocoN

roloCevitisoProloCevitisoProloCevitageNroloCevitageN

roloCevitisoP

roloCevitageNroloCevitageNnoitaterpretnItluseRevitisoPnoitaterpretnItluseRevitisoP

roloCevitageN

sanomohcirT

-wolleYthgiL

neerg

ytireveshtiw

noitaterpretnItluseRevitisoPnoitaterpretnItluseRevitisoPnoitaterpretnItluseRevitageNnoitaterpretnItluseRevitageN

noitaterpretnItluseRevitisoP

ro/dnasitinigaVlairetcaB

elbissop

noitcefni

etycokueLfinoitcefniaidymalhC
lairetcaB.evitisoposla)6enoZ(

evitisoposla)1enoZ(Hpfinoitcefni

rotsaeY,aidymalhC,lairetcaB

detaicossa,snoitcefnisanomohcirT

)1enoZ(HpfinoitcefnisanomohcirT

finoitcefniaidymalhC.evitisoposla

.evitisoposla)4enoZ(doolb

.noitcefni

noitaterpretnItluseRevitageNnoitaterpretnItluseRevitageN

noitaterpretnItluseRevitageN

lairetcablevelwolrooN

llitssanomohcirT.noitcefni

lairetcabrotsaeylevelwolrooN

noitcefnIaidymalhCoN

ylnostseggusegnahcrolocoN

sepytynafosnoitcefnietaredom

tneitapsetacidniegnahcrolocoN

aidymalhCrolanomohcirTonsah

19

T able II FemLab T est Kit Diagnostic Conclusions

2enoZ2enoZ

2enoZ2enoZ

enoZtseTenoZtseT

enoZtseTenoZtseTHp1enoZHp1enoZ

enoZtseT

sitinigaVlairetcaBevitisoP

aidymalhC

sitinigaV

sitinigaVtsaeYevitageNevitageNevitisoP

lanomohcirT

sitinigaV

yhtlaeHevitageNevitageNevitageN

Hp1enoZHp1enoZ

Hp1enoZ

evitageNevitageNevitageNevitisoPevitageNroevitisoPevitisoP

,evitageNro(evitisoP

lanomohcirTthgil

)sitinigaV

2enoZ

roevitisoP

evitageN

evitageNevitageNevitageNevitageNroevitisoPevitisoP

OTHER VAGINAL DISEASES

Sexually transmitted diseases such as syphilis, gonorrhea, HPV or Herpes are not detected directly by the
FemLab test kit. In some cases of such diseases, such as an aggressive Herpes infection, the FemLab test
may report pH, blood, or protein as positive due to the symptoms of the Herpes. In such cases, pelvic
exams will clearly reveal the cause of the symptoms, and additional tests are widely available to confirm
diagnoses. In cases of syphilis or gonorrhea also, symptoms will often be very specific for the disease
state. Thus, even though FemLab may reveal no positive results when sexually transmitted diseases are
causal factors of symptomology , an accurate diagnosis of the disease state can result from additional test
procedures specific for such diseases.

3enoZ3enoZ

3enoZ3enoZ

3enoZ

allerendraG

etirtiN

evitageN

)doirep

doolB4enoZdoolB4enoZ

doolB4enoZdoolB4enoZnietorP5enoZnietorP5enoZ

doolB4enoZ

,evitisoPro(evitageN

lairetcaBereves

)sitinigaV

evitisoProevitageN

)sitinigaVtsaeYereves(

evitisoProevitageN

laurtsnemgnirud(

nietorP5enoZnietorP5enoZ

nietorP5enoZ

ro(evitageN

ereves,evitisoP

)sitinigaVlairetcaB

evitageNevitageN

evitageNevitageN

6enoZ6enoZ

6enoZ6enoZ

6enoZ

setycokueL

evitageN

PERFORMANCE CHARACTERISTICS - FEMLAB CLINICAL TRIAL RESULTS

The performance of the FemLab test kit to detect Bacterial, yeast, Chlamydia and Trichomonas vaginitis
in vaginal fluid specimens collected from symptomatic and asymptomatic patients, was determined in a
multi-center study conducted at three geographically separate clinical sites. A total of 300 women were
enrolled and tested. Study site personnel performed the FemLab test according to a specific protocol, and
also performed traditional tests for comparison to the FemLab results. The study personnel performed
control tests on each patient, and reported diagnoses of the most important vaginitis disease entities:
Bacterial Vaginitis, Gardnerella, Yeast Vaginitis, Trichomonas vaginitis, and Chlamydia Vaginitis. In
addition, clinical evaluations of the severity of symptoms in the presenting patients were recorded.
The traditional tests used as control methods included commercially available pH and Gardnerella tests,
wet mount microscopic evaluation of samples for Trichomonas parasites, and culture systems for detection
of Chlamydia and yeast. A pelvic exam was performed on each patient to determine overall level of
vaginal health.
The clinical trial results are discussed below , first with a general comparison between r esults, and then
specific comparisons of the ability of each method to diagnose infectious organisms. The results for each
diagnosis as found by the FemLab Test Kit are compared to the results found by the control methods, and
are reported in a 2 by 2 chart from which the statistical model may be calculated.
The terms positive (+) and negative (-) are used to refer to the presence or absence of the condition of
interest, the presence of an infectious diagnosis. Thus there are true positives and true negatives, where
both methods of diagnosis agree. There are also two cells on each chart where the diagnoses disagree.
These proportions are described with the following terms:
Sensitivity is the proportion of true positives that are correctly identified by the test, compared to the
control method.

20

Specificity is the proportion of true negatives that are correctly identified by the test, compared to the

control method.
Sensitivity and specificity are one approach to quantifying the diagnostic ability of a diagnostic test.
In T able below , the statistical results of the comparisons between FemLab dia gnoses and control method
diagnoses for the four major infectious organisms responsible for vaginitis are shown.

Statistical Measures of the Sensitivity , Specificity and Ov erall Agreement of the FemLab Test

kit Compared to Control Methods

evitisoPevitisoP

evitisoPevitisoP

sitinigaVsitinigaV

sitinigaVsitinigaVytivitisneSytivitisneS

sitinigaV

sitinigaVlairetcaB%4.98%6.87%9.86%3.39%3.28%13

ytivitisneSytivitisneSyticificepSyticificepS

ytivitisneS

yticificepSyticificepS

yticificepS

evitisoP

evitciderP

eulaV

evitageNevitageN

evitageNevitageN

evitageN
evitciderP

eulaV

llarevOllarevO

llarevOllarevO

llarevO

tnemeergA

niecnelaverPniecnelaverP

niecnelaverPniecnelaverP

niecnelaverP

noitalupoplairt

aidymalhC

sitinigaV

lanomohcirT

sitinigaV

sitinigaVtsaeY%4.19%1.38%1.08%9.29%7.68%93

%0.29%0.29%0.29%3.99%7.89%8

%7.48%3.98%8.57%7.39%0.88%42

The Sensitivity and Specificity for each infectious organism are the key factors for evaluation of the
efficacy of FemLab. The Sensitivity of the FemLab test kit - the agreement with the control methods for
the positive diagnosis of the four various disease states - ranges between 84.7% and 92.0%. This means
that FemLab can be considered very effective in the identification of the infectious organisms; a clinician
can have a high degree of confidence in the results. Indeed, given the known uncertainties in the control
methods of diagnosis, this level of agreement is excellent. In addition, the Specificity - the ability to obtain
negative diagnosis agreement - is also very good, ranging between 78.6% and 92.0%. From the perspective
of the FemLab test kit, many of these cases can be considered misdiagnosed by the control methods,
giving a clinician additional confidence in the FemLab accurac y .
In addition, many cases of FemLab "misdiagnosis" compared to the control method for one particular
disease state are in fact correctly diagnosed for another disease. For instance, many cases diagnosed with
both Bacterial Vaginitis and T richomoniasis by FemLab, only were diagnosed with Bacterial Vaginitis by
the control methods. It is very possible that in fact these women did have Trichomonal infections as well,
since the control method of diagnosis of Trichomoniasis - microscopic evaluation - is well known to be
sensitive to technician error .
These results can be interpreted as providing a high level of confidence to a clinician for use of the
FemLab test kit as a screening method. Only a very small proportion of patients are misdiagnosed
compared to the control method, and many of these are diagnosed correctly for another infection. In
summary, the clinical data sho w clearly that FemLab is very effecti ve in diagnosing the major forms of
vaginitis.

Simbologia / Index of symbols

21

MIN
2°C

MAX

Conservare tra 2° e 30°C

30°C

Store between 2° and 30°C

Solo per uso diagnostico in vitro

For in vitro diagnostic use only

Codice prodotto

Product code

Leggere e seguire attentamente
le istruzioni per l’uso

Read instructions carefully

Dispositivo monouso,
non riutilizzare

Disposable device, do not re-use

Rappresentante autorizzato nella
Comunità europea

Authorized representative
in the European community

Prodotto conforme alla Direttiva
Europea n. 98/79/CE
sui dispositivi diagnostici in vitro

Product complies with European
Directive no. 98/79/EC on In Vitro
diagnostic devices

Data di scadenza
(vedi scatola / bustina)

Expiration date
(see box / package)

Numero di lotto
(vedi scatola / bustina)

Lot number
(see box / package)

Contiene <n> di test

Σ

Contains sufficient for “n” tests

1

Fabbricante

Manufacturer

Leggere attentamente le istruzioni
per l’uso

Please read instructions carefully

Conservare in luogo fresco
ed asciutto

Keep in a cool, dry place

Conservare al riparo dalla luce solare

Keep away from sunlight