IGFBP-1RAPID TEST CASSETTE (VAGINAL SECRETION)

Registration File for

iGFBP-1 Rapid Test Cassette
(Vaginal Secretion)
FIG-502
Document No.: SRG0262

Version: 05
 IGFBP-1 RAPID TEST CASSETTE (VAGINAL SECRETION)

Table of contents

1 BACKGROUND...................................................................................................................... 3
1.1 Test Principle................................................................................................................................................. 3
1.2 Illustrations................................................................................................................................................... 3
1.3 Precautions................................................................................................................................................... 4
1.4 Storage.......................................................................................................................................................... 4
1.5 Stability......................................................................................................................................................... 4
1.6 Specimen Collection and Preparation........................................................................................................... 4
1.7 Description of Test Methods......................................................................................................................... 5
1.8 Interpretation of Result.................................................................................................................................6
1.9 Quality Control.............................................................................................................................................. 6
1.10 Limitation................................................................................................................................................. 6
1.11 Description of Test Methods.....................................................................................................................7
1.11.1 General remarks.........................................................................................................................................................7
1.11.2 Receiving inspection and control of raw materials....................................................................................................7
1.12 Composition of Product............................................................................................................................7
1.13 Manufacturing Procedure........................................................................................................................ 7
2 PERFORMANCE CHARACTERISTICS......................................................................................8
2.1 Sample correlation........................................................................................................................................ 8
2.2 Analytical Sensitivity..................................................................................................................................... 9
2.3 Interfering Substances.................................................................................................................................10
2.4 Cross Reactivity........................................................................................................................................... 11
2.5 Between Day Reproducibility...................................................................................................................... 12
2.6 Between Lot Reproducibility....................................................................................................................... 14
2.7 Accelerated Stability................................................................................................................................... 15
3 BIBLIOGRAPHY................................................................................................................... 18

Figure 1: Test Principle......................................................................................................................................................3

Figure 2: Interpretation of Results....................................................................................................................................5

2
 IGFBP-1 RAPID TEST CASSETTE (VAGINAL SECRETION)

1 BACKGROUND

Insulin-like growth factor-binding protein 1 (iGFBP-1) known as placental protein 12 (PP12) is a

protein that in humans is encoded by the IGFBP-1 gene. IGF-binding proteins (IGFBPs) is believed
to be important in the regulation of fetal and neonatal growth. We previously reported that the
profiles of IGFBPs in fetal cord serum (FCS) were dependent on the growth/metabolic status of
the fetus. It can be detected in cervical secretions of pregnant women, and whether their
presence predicts an increased risk of preterm delivery. The abundance of insulin-like growth
factor binding protein-1 at the maternal-fetal interface in severely preeclamptic pregnancies
suggests that the binding protein may participate in the pathogenesis of the shallow placental
invasion observed in this disorder. Low circulating insulin-like growth factor-I and elevated
insulin-like growth factor binding protein-1 levels may contribute to restricted placental and
therefore fetal growth.
The iGFBP-1 Rapid Test Cassette is a rapid test that qualitatively detects the presence of iGFBP-1
in vaginal secretion specimen at the sensitivity of 25ng/ml.
1.1 Test Principle
The iGFBP-1 (vaginal secretion) has been designed to detect iGFBP-1 through visual
interpretation of color development in the internal strip. The membrane was immobilized with
anti-iGFBP-1 antibodies on the test region. During the test, the specimen is allowed to react with
colored anti-iGFBP-1 antibodies colloidal gold conjugates, which were precoated on the sample
pad of the test. The mixture then moves on the membrane by a capillary action, and interacts
with reagents on the membrane. If there was enough iGFBP-1 in specimens, a colored band will
form in the T region of the membrane. Presence of colored band indicates a positive result,
while its absence indicates a negative result. Appearance of a colored band in the control region
serves as a procedural control. This indicates that proper volume of specimen has been added
and membrane wicking has occurred.
1.2 Illustrations

Figure 1: Test Principle

As shown in Figure 1 above, the specimen (A) migrates via capillary action along the membrane
to react with the colored conjugate (B). iGFBP-1 Antigen present in the specimen bind to the
conjugate, forming a colored antibody-antigen complex. anti-iGFBP-1 antibodies immobilized in

3
 IGFBP-1 RAPID TEST CASSETTE (VAGINAL SECRETION)

the test line region(C) of the membrane captures the complex. The formation of a visible red line
indicates a positive result (C). The absence of a red line formation in the test line region indicates
a negative result.The resulting visible colored band (D) confirms control line.
1.3 Precautions
 For professional in vitro diagnostic use only.
 Do not use after expiration date indicated on the package. Do not use the test if its foil
pouch is damaged. Do not reuse tests.
 This kit contains products of animal origin. Certified knowledge of the origin and/or sanitary
state of the animals does not totally guarantee the absence of transmissible pathogenic
agents. It is therefore, recommended that these products be treated as potentially
infectious, and handled observing the usual safety precautions (do not ingest or inhale).
 Avoid cross-contamination of specimens by using a new specimen collection container for
each specimen obtained.
 Read the entire procedure carefully prior to performing any tests.
 Do not eat, drink or smoke in the area where the specimens and kits are handled. Handle all
specimens as if they contain infectious agents. Observe established precautions against
microbiological hazards throughout the procedure and follow the standard procedures for
proper disposal of specimens. Wear protective clothing such as laboratory coats, disposable
gloves and eye protection when specimens are assayed.
 Do not interchange or mix reagents from different lots.
 Humidity and temperature can adversely affect results.
 The used testing materials should be discarded in accordance with local, state and/or
federal regulations.
 DO NOT use this test until 72 hours after the application of vaginal preparations like
antifungal agents.

1.4 Storage
Store the test at 2-30°C. Freezing must be avoided.
1.5 Stability
The iGFBP-1 Rapid Test Cassette (vaginal secretion) is stable for 24 months from the date of
production when stored properly in unopened aluminum foil pouches with desiccant.
1.6 Specimen Collection and Preparation
 The Insulin-like growth factor-binding protein 1 (iGFBP-1) rapid test (vaginal secretion) is
intended only for use with women vaginal secretion specimens.

4
 IGFBP-1 RAPID TEST CASSETTE (VAGINAL SECRETION)

 The specimen is cervicovaginal secretion that is extracted into the Specimen Extraction
Solution provided. A vaginal secretion sample is obtained using a sterile polyester swab from
the posterior fomix of the vagina during a sterile speculum examination or, if no vaginal fluid
is visible, the sample may be taken from the cervix. Take not to touch anything with the
swab before taking the sample. The swab should be left in the vagina or cervix for
approximately 10~15 seconds to allow it to absorb the secretion samples.
 Open the Specimen Extraction Solution tube and put it in a vertical position. The specimen
is extracted immediately from the swab by swirling the swab vigorously in the extraction
solution for approximately 10 seconds. Specimens should be tested as soon as possible after
extraction but in any case no more than 4 hours after specimen collection and extraction. If
a specimen can not be tested within this time it should be frozen. After thawing, the
specimens can be tested as described below.
 Perform the testing immediately after the specimen collection. Do not leave the specimens
at room temperature for prolonged periods. Specimens may be stored at 2-8°C for up to 72
hours.
 Bring specimens to room temperature prior to testing.
 Pack the specimens in compliance with applicable regulations for transportation of
etiological agents, in case they need to be shipped.
1.7 Description of Test Methods
Allow the test, specimen, buffer and/or controls to reach room temperature (15-30℃) prior to
testing.

 Remove the test from its sealed pouch, and place it on a clean, level surface. Label the test
cassette with patient or control identification. To obtain a best result, the assay should be
performed within one hour.

 Insert the swab into the dilution tube, rotate for 20 times. Then press the swab against the
side of the tube and squeeze the bottom of the tube as the swab is withdrawn. Discard the
swab.

 Fit the cap onto the tube. Remove the top part of the cap. Place the test cassette on a clean
and level surface. Add 3 full drops of solution (approx. 100 µL) to the specimen well (S), and
then start the timer.

 Wait for the colored band to appear. The result should be read at 5 minutes. Do not
interpret the result after 20 minutes.

3 Drops of Specimen iGFBP-1

C
T

5
S

T
C

Positive Negative Invalid

iGFBP-1

S
 IGFBP-1 RAPID TEST CASSETTE (VAGINAL SECRETION)

Figure 2: Interpretation of Results

1.8 Interpretation of Result
POSITIVE: A colored band appears in the control band region (C) and another colored band
appears in the T band region.
NEGATIVE: One colored band appears in the control band region (C). No band appears in the
test band region (T).
INVALID: Control band fails to appear. Results from any test which has not produced a control
band at the specified reading time must be discarded. Please review the procedure and repeat
with a new test. If the problem persists, discontinue using the kit immediately and contact your
local distributor.
NOTE:
1. The intensity of the color in test region (T) may vary depending on the concentration of
aimed substances present in the specimen. Therefore, any shade of color in the test region
should be considered positive. Besides, the substances level can not be determined by this
qualitative test.
2. Insufficient specimen volume, incorrect operation procedure, or performing expired tests
are the most likely reasons for control band failure.
1.9 Quality Control
Internal procedural controls are included in the test. A colored band appearing in the control
region (C) is considered an internal positive procedural control. It confirms sufficient specimen
volume and correct procedural technique.
External controls are not supplied with this kit. It is recommended that positive and negative
controls be tested as a good laboratory practice to confirm the test procedure and to verify
proper test performance.
1.10 Limitation
 The Insulin-like growth factor-binding protein 1 (iGFBP-1) rapid test (vaginal secretion) is for
professional in vitro diagnostic use, and should be used for the qualitative detection of
iGFBP-1 only.
 As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results
of a single test, but should only be made by the physician after all clinical and laboratory
findings have been evaluated.
 If the test result is negative and clinical symptoms persist, additional testing using other
clinical methods is recommended. A negative result does not at any time preclude the

6
 IGFBP-1 RAPID TEST CASSETTE (VAGINAL SECRETION)

possibility of rupture of fetal membranes.

 Use of vaginal preparations (such as ascorbic acid vaginal tablets) may affect the result of
iGFBP-1 Rapid Test.

1.11 Description of Test Methods

1.11.1 General remarks

The Quality Control department performs testing according to written procedures. Testing
equipment is checked prior to use and calibrated at scheduled frequencies.

1.11.2 Receiving inspection and control of raw materials

A sample batch of each raw material (chemicals, packaging and labeling) is inspected/tested
(where applicable) for suitability and functionality. Primary packaging is inspected for correct
dimensions, cleanliness and suitability. Only QC “APPROVED” raw material is employed for
production.
1.12 Composition of Product
A) Anti-iGFBP-1 antibody B) iGFBP-1 antibody
C) Goat anti-Mouse IgG D) Specimens dilution tubes with buffer
E) Specimens collection swabs F) NC Membrane
G) Adhesive plastic backing H) Label pad
I) Absorbent pad J) Sample pad
K)Plastic cassette L) Desiccant (in pouch)
M) Pouch
1.13 Manufacturing Procedure
 Precoat the colored iGFBP-1 Antibody gold colloidal on the label pad.

 Use the sprayer to dispense anti-iGFBP-1 antibody and Goat anti-mouse IgG onto the
membrane.

 Assemble the membrane, label pad, Absorbent pad and sample pad on the plastic backing.

 Cut the plastic backing into strips of selected size.

 Lay the strip into the plastic device, pack the device and a desiccant packet into a pouch and
seal the pouch.

7
 IGFBP-1 RAPID TEST CASSETTE (VAGINAL SECRETION)

 Test the device according to QC procedure and release the finished product.

2 PERFORMANCE CHARACTERISTICS
2.1 Sample correlation
The iGFBP-1 Rapid Test Cassette (vaginal secretion) has been tested with a leading commercial
iGFBP-1 Rapid Test using clinical specimens. Results were presented in table below.
Table: Clinical Study from FIG-502
Method Other Commercial Test Total Results

iGFBP-1 Rapid Results Positive Negative

Test
Cassette(Vaginal Positive 102 3 105
Secretion)
Negative 2 147 149

Total results 104 150 254

Relative Sensitivity: 98.1% (95%CI:*93.2%-99.8%)

Relative Specificity: 98.0% (95%CI:*94.3%-99.6%)
Overall Accuracy: 98.0% (95%CI:*95.5%-99.4%) *Confidence Intervals

8
 IGFBP-1 RAPID TEST CASSETTE (VAGINAL SECRETION)

2.2 Analytical Sensitivity

The analytical sensitivity was determined by spiking negative (0.5% BSA-PBS) with intact iGFBP-1
at 10, 25, 50, 75, 100ng/ml. The iGFBP-1 were randomized and coded. A total of 3 replicates for
each standard were tested according to the package insert. The specimens were tested with
visual interpretations occurring at 5 and 20 minutes after specimen application. Results are
presented in Table below.
Table: Minimum detection limit study
iGFBP-1 concentration IGF14090001-T IGF14090002-T IGF14090003-T
10ng/ml - - - - - - - - -
25ng/ml + + + + + + + + +
50ng/ml + + + + + + + + +
75ng/ml + + + + + + + + +
100ng/ml + + + + + + + + +

Note: *means all the results were negative

**means all the results were positive
Conclusion: As indicated in the table above: all specimens with iGFBP-1 concentration equal to
or higher than 25ng/ml show positive results. The analytical sensitivity of iGFBP-1 Rapid Test
Cassette (vaginal secretion) is 25ng/ml.

9
 IGFBP-1 RAPID TEST CASSETTE (VAGINAL SECRETION)

2.3 Interfering Substances

Analytes were spiked into diluting buffer and 50ng/ml positive sample at the concentrations
listed. The specimens were tested in triplicate with 3 lots of test cassettes. Visual interpretations
were made at 5 and 20 minutes after specimen application. The results are presented in table
below.
Table: Interfering Substances Results

Table: Interfering Substance

Sample
Analytes Concentration Negative
IGF14090001-T IGF14090002-T IGF14090003-T
Globulin 20mg/ml -* - - - - - - - -
Hemoglobin 1000mg/dl - - - - - - - - -
Bilirubin 1000mg/dl - - - - - - - - -
Uric acid 20mg/ml - - - - - - - - -
Mucoprotein 200mg/dl - - - - - - - - -
Human serum
2000mg/dl - - - - - - - - -
albumin
Sample
Analytes Concentration 50ng/ml
IGF14090001-T IGF14090002-T IGF14090003-T
Globulin 20mg/ml +** + + + + + + + +
Hemoglobin 1000mg/dl + + + + + + + + +
Bilirubin 1000mg/dl + + + + + + + + +
Uric acid 20mg/ml + + + + + + + + +
Mucoprotein 200mg/dl + + + + + + + + +
Human serum
2000mg/dl + + + + + + + + +
albumin

Note: “*” means negative result “**” means positive result

Conclusion: No substances showed any interference with the test. There were no differences
observed between the results at 5 minutes and the results at 20 minutes.

10
 IGFBP-1 RAPID TEST CASSETTE (VAGINAL SECRETION)

2.4 Cross Reactivity

Cross reactivity with following organisms has been studied at 1E+09organisms/ml. Visual
interpretations were recorded at 5 and 20 minutes after specimen application. Results are
presented in Table below:

Table: Cross Reactivity

FIG-502 IGF14090001-T IGF14090002-T IGF14090003-T

Specimen 5min 20min 5min 20min 5min 20min

M.urealyticum -* - - - - -
Candida albicans - - - - - -
Chlamydia trachomatis - - - - - -
Enterococcus faecalis - - - - - -
Enterococcus faecium - - - - - -
Gardnerella vaginalis - - - - - -
Group B Streptococcus - - - - - -
Neisseria gonorrhea - - - - - -
Neisseria meningitides - - - - - -
Proteus mirabilis - - - - - -
Proteus vulgaris - - - - - -
Note: “*” means negative result
Conclusion: There is no cross-reaction with the substance above at 10 minutes.

11
 IGFBP-1 RAPID TEST CASSETTE (VAGINAL SECRETION)

2.5 Between Day Reproducibility

The iGFBP-1 was diluted to 25ng/ml and 50ng/ml with extraction buffer. Extraction buffer,
25ng/ml, 50ng/ml iGFBP-1samples were run individually on ten separate days using the 3 lots of
cassettes. Results were rated visually as positive or negative at 5 minutes and 20 minutes after
specimen application. Results are presented in table below.
Table: Between Day Results

Lot#: IGF14090001-T

Day 1 2 3 4 5 6 7 8 9 10

5 minutes 10-* 10- 10- 10- 10- 10- 10- 10- 10- 10-
Extraction
buffer 20 10- 10- 10- 10- 10- 10- 10- 10- 10- 10-
minutes

5 minutes 10+* 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+
*
25ng/ml
20 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+
minutes

5 minutes 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+
50ng/ml
20 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+
minutes

Lot#: IGF14090002-T

Day 1 2 3 4 5 6 7 8 9 10

5 minutes 10- 10- 10- 10- 10- 10- 10- 10- 10- 10-
Extraction
buffer 20 10- 10- 10- 10- 10- 10- 10- 10- 10- 10-
minutes

25ng/ml 5 minutes 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+

12
 IGFBP-1 RAPID TEST CASSETTE (VAGINAL SECRETION)

20 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+
minutes

5 minutes 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+
50ng/ml
20 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+
minutes

Lot#: IGF14090003-T

Day 1 2 3 4 5 6 7 8 9 10

5 minutes 10- 10- 10- 10- 10- 10- 10- 10- 10- 10-
Extraction
buffer 20 10- 10- 10- 10- 10- 10- 10- 10- 10- 10-
minutes

5 minutes 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+
25ng/ml
20 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+
minutes

5 minutes 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+
50ng/ml
20 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+
minutes

Note: “*” means 10 negative result “**”means 10 positive result

Conclusion: Test results were consistent over ten day’s period.

13
 IGFBP-1 RAPID TEST CASSETTE (VAGINAL SECRETION)

2.6 Between Lot Reproducibility

The iGFBP-1 was diluted to 25ng/ml and 50ng/ml with extraction buffer. Extraction buffer,
25ng/ml, 50ng/ml iGFBP-1samples were run in replicates of three in three separate lots of
product. Results were rated visually as positive or negative at 5 minutes and 20 minutes after
specimen application. Results are presented in table below.
Table: Between Lot Result

IGF14090001-T IGF14090002-T IGF14090003-T

Sample No.
5 min 10 min 5 min 10 min 5 min 10 min

1 -* - - - - -

Extraction
2 - - - - - -
buffer

3 - - - - - -

1 +** + + + + +

25ng/ml 2 + + + + + +

3 + + + + + +

1 + + + + + +

50ng/ml 2 + + + + + +

3 + + + + + +

Note: “*” means negative result, “**” means positive result

Conclusion: Test results were consistent between the 3 lots of test cassettes.

14
 IGFBP-1 RAPID TEST CASSETTE (VAGINAL SECRETION)

2.7 Accelerated Stability

Accelerated Stability of theiGFBP-1 Rapid Test Cassette (vaginal secretion) was evaluated using
samples from three different lots. These samples were placed in an incubator with the
temperature calibrated at 45℃ and relative humidity (RH) calibrated at 60%. A series of stability
tests were performed at 0, 7, 14, 21, 28, 35, 42, 56, 77, 84 days for 45 ℃ . About 55 ℃ , some
performance study would be tested at 0, 7, 14, 21, 28, 35, 42 days according to Arrhenius Plot. See
Table in below. Test cassettes were assayed using negative (Extraction buffer), 25ng/ml and
50ng/ml. Testing at each specific time interval consisted of 3 repl1icates for each specimen. The
tests were performed according to the package insert. The results are presented in below Table.

Arrhenius Formula:
In K=-Ea/RT + In A
“K” meanRate constant
“A” means Arrhenius constant
“Ea” means Activation energy
“R”means Gas constant
“T” means Temperature in Kelvin

Table: Time line for Accelerated Stability Study

Day 14 21 28 35 42 56 75 84
0day 7days
Temp. days days days days days days days days

45℃ √ √ √ √ √ √ √ √ √ √
55℃ √ √ √ √ √ √ √ N/A N/A N/A

Table: 45℃Accelerated Stability Summary

FIG-502
Days Specimen
IGF14090001-T IGF14090002-T IGF14090003-T
Extraction buffer -* - - - - - - - -
0 25ng/ml +** + + + + + + + +
50ng/ml + + + + + + + + +
Extraction buffer - - - - - - - - -
7 25ng/ml + + + + + + + + +
50ng/ml + + + + + + + + +

15
 IGFBP-1 RAPID TEST CASSETTE (VAGINAL SECRETION)

Extraction buffer - - - - - - - - -
14 25ng/ml + + + + + + + + +
50ng/ml + + + + + + + + +
Extraction buffer - - - - - - - - -
21 25ng/ml + + + + + + + + +
50ng/ml + + + + + + + + +
Extraction buffer - - - - - - - - -
28 25ng/ml + + + + + + + + +
50ng/ml + + + + + + + + +
Extraction buffer - - - - - - - - -
35 25ng/ml + + + + + + + + +
50ng/ml + + + + + + + + +
Extraction buffer - - - - - - - - -
42 25ng/ml + + + + + + + + +
50ng/ml + + + + + + + + +
Extraction buffer - - - - - - - - -
56 25ng/ml + + + + + + + + +
50ng/ml + + + + + + + + +
Extraction buffer - - - - - - - - -
75 25ng/ml + + + + + + + + +
50ng/ml + + + + + + + + +

Table: 55℃Accelerated Stability Summary

FIG-502
Days Specimen
IGF14090001-T IGF14090002-T IGF14090003-T
Extraction buffer - - - - - - - - -
0 25ng/ml + + + + + + + + +
50ng/ml + + + + + + + + +
Extraction buffer - - - - - - - - -
7 25ng/ml + + + + + + + + +
50ng/ml + + + + + + + + +
Extraction buffer - - - - - - - - -
14 25ng/ml + + + + + + + + +
50ng/ml + + + + + + + + +
21 Extraction buffer - - - - - - - - -

16
 IGFBP-1 RAPID TEST CASSETTE (VAGINAL SECRETION)

25ng/ml + + + + + + + + +
50ng/ml + + + + + + + + +
Extraction buffer - - - - - - - - -
28 25ng/ml + + + + + + + + +
50ng/ml + + + + + + + + +
Extraction buffer - - - - - - - - -
35 25ng/ml + + + + + + + + +
50ng/ml + + + + + + + + +
Extraction buffer - - - - - - - - -
42 25ng/ml + + + + + + + + +
50ng/ml + + + + + + + + +

Note: *means all the three results were negative

**means all the three results were positive

Conclusion: The iGFBP-1 Rapid Test was stable at 45℃ for 84 days and at 55℃ for 42 days. These
data were plotted on an Arrhenius Plot and the shelf life of this product was determined to be at
least 24 months from the date of manufacture.

17
 IGFBP-1 RAPID TEST CASSETTE (VAGINAL SECRETION)

3 BIBLIOGRAPHY
1. Erdemoglu and Mungan T. Significance of detecting insulin-like growth factor binding
protein-1 in cervicovaginal secretions: Comparison with nitrazine test and amoniotic fluid
volume assessment. Acta Obstet Gynecol Scand (2004) 83: 622-626
2. Vogel Ida, Grønbaek Henning, Thorsen Poul, Flyvbjerg Allan. Insulin-like growth factor
binding protein 1 (IGFBP-1) in vaginal fluid in pregnancy. In Vivo, 2004, Vol.18 (1), pp.37-41
3. Woytoń J, Kłósek A, Zimmer M, Fuchs T. Insulin-like growth factor binding protein 1 (IGFBP-1)
in vaginal secretion as a marker of premature rupture of amniotic membranes. Ginekologia
polska, 2000, Vol.70 (11), pp.809-14
4. Rutanen E M, Pekonen F, Kärkkäinen T. Measurement of insulin-like growth factor binding
protein-1 in cervical/vaginal secretions: comparison with the ROM-check Membrane
Immunoassay in the diagnosis of ruptured fetal membranes Clinica chimica acta;
international journal of clinical chemistry, 1993, Vol.214 (1), pp.73-81.

18
 IGFBP-1 RAPID TEST CASSETTE (VAGINAL SECRETION)

Document History Summary

Version
Date Description Remark
No.

01 2014.10.31 / N/A

Follow package insert and improve

02 2017.08.29 technical files. Add the 1.3, 1.6, 1.8, N/A
1.9, 1.10 etc.

【1 BACKGROUND 】 "It can be

detected in cervical secretions of
pregnant women with preterm
03 2017.12.29 N/A
uterine contractions" changed to "It
can be detected in cervical
secretions of pregnant women"

Correct mistakes in 2.2 Analytical

04 2019.03.13 N/A
Sensitivity

1.3 Precautions add the “DO NOT

use this test until 72 hours after the
application of vaginal preparations
like antifungal agents.”
05 2019.11.28 N/A
1.10 Limitation add the “Use of
vaginal preparations (such as
ascorbic acid vaginal tablets) may
affect the result of iGFBP-1 Rapid
Test.”

19