CMV IGG/IGM COMBO RAPID TEST CASSETTE (SERUM/PLASMA)

Registration File of
CMV IgG/IgM Combo Rapid Test
Cassette
(Serum/Plasma)
ICGM-325
Registration No.: SRG0152
Version: 01
 CMV IGG/IGM COMBO RAPID TEST CASSETTE (SERUM/PLASMA)

Table of Contents
1BACKGROUND ............................................................................................................................. 3
1.1Test Principle ...................................................................................................................................................................... 3
1.2Illustrations ........................................................................................................................................................................ 3
1.3Precautions ........................................................................................................................................................................ 4
1.4Storage ............................................................................................................................................................................... 4
1.5Stability .............................................................................................................................................................................. 4
1.6Specimen Collection and Preparation ................................................................................................................................ 4
1.7Directions for Use ............................................................................................................................................................... 4
1.8Interpretation of Result ...................................................................................................................................................... 5
1.9Quality Control ................................................................................................................................................................... 5
1.10Limitation ......................................................................................................................................................................... 5
1.11Description of Test Methods ............................................................................................................................................. 6
1.11.1General Remarks ........................................................................................................................................................... 6
1.11.2Receiving Inspection and Control of Raw Materials ...................................................................................................... 6
1.12Composition of Product .................................................................................................................................................... 6
1.13Manufacturing Procedure ................................................................................................................................................ 6
2PERFORMANCE CHARACTERISTICS ............................................................................................... 8
2.1Sample Correlation ............................................................................................................................................................. 8
2.2Interfering Substances ........................................................................................................................................................ 9
2.3Cross Reactivity ................................................................................................................................................................ 12
2.4Between Day Reproducibility ........................................................................................................................................... 13
2.5Between Lot Reproducibility............................................................................................................................................. 14
2.6Accelerated Stability......................................................................................................................................................... 18
3BIBLIOGRAPHY .......................................................................................................................... 22
Document History Summary ................................................................................................................................................. 23

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

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

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 CMV IGG/IGM COMBO RAPID TEST CASSETTE (SERUM/PLASMA)

1 BACKGROUND
Cytomegalovirus is a herpes virus. It is a leading etiological agent for congenital abnormalities
and complications among those who receive massive blood transfusions and
immunosuppressive therapy. About half of pregnant women who contract a primary infection
spread the disease to their fetus.1,2,3 Infection during pregnancy may cause mental retardation,
blindness, and/or deafness of the fetus.
The detection of anti-CMV IgM and IgG antibodies enables effective diagnosis of acute or recent
CMV infection. The CMV IgG/IgM Combo Rapid Test Cassette (Serum/Plasma) is a rapid
chromatographic immunoassay for the qualitative detection of IgM and IgG antibodies to CMV in
serum or plasma specimens.
Test Principle
The CMV IgG/IgM Combo Rapid Test Cassette (Serum/Plasma) is a qualitative, lateral flow
immunoassay for the detection of IgG and IgM antibodies to CMV in serum or plasma specimens.
In this test, mouse anti-human IgG and goat anti-human IgM are coated in the test line regions
of the test. During testing, the serum or plasma specimen reacts with CMV antigen coated
particles in the test strip. The mixture then migrates forward on the membrane by capillary
action and reacts with the mouse anti-human IgG or goat anti-human IgM on the membrane in
the test line region. The presence of a colored line in the test line region indicates a positive
result for CMV infection, while its absence indicates a negative result for that infection.
To serve as a procedural control, a colored line will always appear in the respective control line
regions of all the two strips indicating that proper volume of specimen has been added and
membrane wicking has occurred.
Illustrations

Figure 1: Test Principle

As shown in illustration above, the specimen (A) migrates via capillary action along the
membrane to react with the colored conjugate (B). CMV antibody present in the specimen binds
to the conjugate, forming a colored antibody-antigen complex. The CMV antigen in the test zone
of the membrane captures the test region (C). The formation of a visible colored line in the test

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region indicates a positive result (C). The absence of a colored line in the test zones suggests a
negative result. In the control zone of the membrane, immobilized reagents capture colored
conjugate regardless of test specimen composition. The resulting visible colored band (D)
confirms control line.

Precautions
1. For professional in vitro diagnostic use only. Do not use after the expiration date.
2. The test should remain in the sealed pouch until use.
3. All specimens should be considered potentially hazardous and handled in the same manner
as an infectious agent.
4. The used test should be discarded according to local regulations.
5. Humidity and temperature can adversely affect results.
Storage
Store the test at 2-30°C. Freezing must be avoided.
Stability
The CMV IgG/IgM Combo Rapid Test Cassette (Serum/Plasma) is stable for 24 months from the
date of production when stored properly in unopened aluminum foil pouches with desiccant.
Specimen Collection and Preparation
 The CMV IgG/IgM Combo Rapid Test Cassette (Serum/Plasma) can be performed using
either serum or plasma specimens.
 Separate the serum or plasma from blood as soon as possible to avoid hemolysis. Only
clear, non-hemolyzed specimens can be used.
 Testing should be performed immediately after the specimens have been collected. Do not
leave the specimens at room temperature for prolonged periods. Specimens may be stored
at 2-8°C for up to 3 days. For long-term storage, specimens should be kept below -20°C.
 Bring specimens to room temperature prior to testing. Frozen specimens must be
completely thawed and mixed well prior to testing. Specimens should not be frozen and
thawed repeatedly.
 If specimens are to be shipped, they should be packed in compliance with local regulations
for the transportation of etiologic agents.
Directions for Use
Allow the test, specimen, and/or controls to reach room temperature (15-30°C) prior to testing.
1. Bring the pouch to room temperature before opening it. Remove the test cassette from the
sealed pouch and use it as soon as possible. Best results will be obtained if the assay is
performed within one hour.
2. Place the test cassette on a clean and level surface. Hold the dropper vertically; draw the

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specimen about 1cm above the upper end of the nozzle as shown in illustration below.
Transfer 1 full drop (approx. 20μL) of specimen to each sample well respectively, then add
2 drops of buffer (approximately 80μL) and start the timer. See the illustration below.
3. Wait for the colored line(s) to appear. The result should be read at 15 minutes. Do not
interpret results after 20 minutes.

Add 1 full drop of specimen

Fill upto and 2 drops of buffer to the
this point specimen well
CMV

C C
lgG lgM
lgG
C

Positive Negative Invalid

CMV
lgM
C

Figure 2: Interpretation of Results

Interpretation of Results
POSITIVE:* Two colored lines appear. One colored line should always appear in the control line
region (C) and another line should be in the test line region.
*NOTE: The intensity of the color in the test line regions may vary depending on the concentration of
CMV antibodies present in the specimen. Therefore, any shade of color in the test line region should
be considered positive.
NEGATIVE: One colored line appears in the control line region (C). No line appears in the test line
regions.
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural
techniques are the most likely reasons for control line failure. Review the procedure and repeat
the test with a new test. If the problem persists, discontinue using the test kit immediately and
contact your local distributor.
Quality Control
Internal procedural controls are included in the test. A colored line appearing in the control
region (C) is an internal valid procedural control. It confirms sufficient specimen volume and
correct procedural technique.
Control standards are not supplied with this kit; however, 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.
Limitation
1. The CMV IgG/IgM Combo Rapid Test Cassette (Serum/Plasma) is for in vitro diagnostic use
only. This test should be used for detection of IgM and IgG antibodies to CMV in serum or
plasma specimens. Neither the quantitative value nor the rate of increase in the concentration

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of IgM and IgG antibodies to CMV can be determined by this qualitative test.
2. The CMV IgG/IgM Combo Rapid Test Cassette (Serum/Plasma) will only indicate the presence
of IgM or IgG antibodies to CMV in the specimen and should not be used as the sole criteria
for the diagnosis of CMV infections.
3. As with all diagnostic tests, all results must be considered with other clinical information
available to the physician.
4. If the test result is negative and clinical symptoms persist, additional follow-up testing using
other clinical methods is suggested. A negative result at any time does not preclude the
possibility of CMV infection.
Description of Test Methods

1.1.1 General Remarks

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

1.1.2 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.
Composition of Product
A) Mouse anti-human IgG B) CMV antigen
C) Biotin-BSA D) Goat anti-mouse IgG
E) Adhesive plastic backing F) Label pad
G) Absorbant pad H) Sample pad
I) NC membrane J) Desiccant (in pouch)
K) Pouch L) Buffer
M) Sample dropper N) Streptavidin-rIgG
O) Goat anti-human IgM

Manufacturing Procedure
 Coat the latex conjugated mouse anti-human IgG, goat anti-human IgM and Biotin-BSA on
the label pad.
 Use the sprayer to dispense Streptavidin-rIgG, goat anti-mouse IgG and CMV antigen onto
the membrane.
 Assemble the membrane, label pad, absorbent pad and sample pad on the plastic backing.

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 Use the cutter to cut the plastic backing into strips of selected size.
 Test the strips according to the QC procedure and release the finished product.

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2 PERFORMANCE CHARACTERISTICS
Sample Correlation

2.1.1 Method

The CMV IgG/IgM Combo Rapid Test Cassette (Serum/Plasma) has been evaluated with
specimens obtained from a population of symptomatic and asymptomatic individuals. ELISA
served as the reference method for the CMV IgG/IgM Rapid Test Cassette (Serum/Plasma). The
specimen was considered positive if ELISA results were positive. The specimen was also
considered negative if the ELISA results were negative. The lot of AllTest CMV IgG/IgM Combo
Rapid Test is CGM16090007-T.

Table: Sample Correction Result

Method CMV EIA (IgM)

Total Results
Results Positive Negative
CMV IgM Rapid Test
Positive 28 4 32
Cassette
Negative 2 266 268
Total Results 30 270 300
Relative Sensitivity: 93.3% (95%CI*: 77.9%-99.2%) *Confidence Interval
Relative Specificity: 98.5% (95%CI*: 96.3%-99.6%)
Accuracy: 98.0% (95%CI*: 95.7%-99.3%)
Method CMV EIA (IgG)
Total Results
Results Positive Negative
CMV IgG Rapid Test
Positive 27 5 32
Cassette
Negative 3 265 268
Total Results 30 270 300
Relative Sensitivity: 90.0% (95%CI*: 73.5%-97.9%) *Confidence Interval
Relative Specificity: 98.1% (95%CI*: 95.7%-99.4%)
Accuracy: 97.3% (95%CI*: 94.8%-98.8%)

2.1.2 Conclusion

Clinical test has been conducted on altogether 300 specimens for CMV IgG and 300 specimens
for CMV IgM. The AllTest tests were parallel comparison studied with ELISA, the total conformity
rate between AllTest CMV IgG/IgM Combo Rapid Test Cassette and ELISA rapid test is 98.0% for
IgM result and 97.3% for IgG result, and this indicate that the two has got high conformity in the

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respect of CMV IgG/IgM Combo Rapid test.

Interfering Substances
2.2.1. Method
Analytes were spiked into negative plasma and serum pools (ELISA confirmed) and middle
positive plasma and serum specimens (ELISA confirmed) at the concentrations listed. The
specimens were tested in triplicate with visual interpretations occurring at 15 minutes after
specimen application. Results are presented in Table below.
Table: Interfering Substance
CGM16090007-T
Serum Plasma
Analytes Conc.
CMV IgG CMV IgG
Negative Negative
middle middle
Ascorbic acid 2g/dl -* - - +** + + - - - + + +
Gentisic acid 20mg/dl - - - + + + - - - + + +
Bilirubin 1000mg/dl - - - + + + - - - + + +
Acetylsalicylic Acid 20mg/dl - - - + + + - - - + + +
Acetaminophen 20mg/dl - - - + + + - - - + + +
Caffeine 20mg/dl - - - + + + - - - + + +
Phenylpropanolamine 20mg/dl - - - + + + - - - + + +
Salicylic Acid 20mg/dl - - - + + + - - - + + +
EDTA 20mg/dl - - - + + + - - - + + +
Ethanol 10% - - - + + + - - - + + +
Glucose 20mg/dl - - - + + + - - - + + +
Phenothiazine 20mg/dl - - - + + + - - - + + +
CGM16090008-T
Serum Plasma
Analytes Conc.
CMV IgG CMV IgG
Negative Negative
middle middle
Ascorbic acid 2g/dl - - - + + + - - - + + +
Gentisic acid 20mg/dl - - - + + + - - - + + +
Bilirubin 1000mg/dl - - - + + + - - - + + +
Acetylsalicylic Acid 20mg/dl - - - + + + - - - + + +
Acetaminophen 20mg/dl - - - + + + - - - + + +
Caffeine 20mg/dl - - - + + + - - - + + +
Phenylpropanolamine 20mg/dl - - - + + + - - - + + +
Salicylic Acid 20mg/dl - - - + + + - - - + + +
EDTA 20mg/dl - - - + + + - - - + + +
Ethanol 10% - - - + + + - - - + + +
Glucose 20mg/dl - - - + + + - - - + + +
Phenothiazine 20mg/dl - - - + + + - - - + + +
Analytes Conc. CGM16090009-T

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Serum Plasma
CMV IgG CMV IgG
Negative Negative
middle middle
Ascorbic acid 2g/dl - - - + + + - - - + + +
Gentisic acid 20mg/dl - - - + + + - - - + + +
Bilirubin 1000mg/dl - - - + + + - - - + + +
Acetylsalicylic Acid 20mg/dl - - - + + + - - - + + +
Acetaminophen 20mg/dl - - - + + + - - - + + +
Caffeine 20mg/dl - - - + + + - - - + + +
Phenylpropanolamine 20mg/dl - - - + + + - - - + + +
Salicylic Acid 20mg/dl - - - + + + - - - + + +
EDTA 20mg/dl - - - + + + - - - + + +
Ethanol 10% - - - + + + - - - + + +
Glucose 20mg/dl - - - + + + - - - + + +
Phenothiazine 20mg/dl - - - + + + - - - + + +
CGM16090007-T
Serum Plasma
Analytes Conc.
CMV IgM CMV IgM
Negative Negative
middle middle
Ascorbic acid 2g/dl -* - - +** + + - - - + + +
Gentisic acid 20mg/dl - - - + + + - - - + + +
Bilirubin 1000mg/dl - - - + + + - - - + + +
Acetylsalicylic Acid 20mg/dl - - - + + + - - - + + +
Acetaminophen 20mg/dl - - - + + + - - - + + +
Caffeine 20mg/dl - - - + + + - - - + + +
Phenylpropanolamine 20mg/dl - - - + + + - - - + + +
Salicylic Acid 20mg/dl - - - + + + - - - + + +
EDTA 20mg/dl - - - + + + - - - + + +
Ethanol 10% - - - + + + - - - + + +
Glucose 20mg/dl - - - + + + - - - + + +
Phenothiazine 20mg/dl - - - + + + - - - + + +
CGM16090008-T
Serum Plasma
Analytes Conc.
CMV IgM CMV IgM
Negative Negative
middle middle
Ascorbic acid 2g/dl - - - + + + - - - + + +
Gentisic acid 20mg/dl - - - + + + - - - + + +
Bilirubin 1000mg/dl - - - + + + - - - + + +
Acetylsalicylic Acid 20mg/dl - - - + + + - - - + + +
Acetaminophen 20mg/dl - - - + + + - - - + + +
Caffeine 20mg/dl - - - + + + - - - + + +
Phenylpropanolamine 20mg/dl - - - + + + - - - + + +

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Salicylic Acid 20mg/dl - - - + + + - - - + + +

EDTA 20mg/dl - - - + + + - - - + + +
Ethanol 10% - - - + + + - - - + + +
Glucose 20mg/dl - - - + + + - - - + + +
Phenothiazine 20mg/dl - - - + + + - - - + + +
CGM16090009-T
Serum Plasma
Analytes Conc.
CMV IgM CMV IgM
Negative Negative
middle middle
Ascorbic acid 2g/dl - - - + + + - - - + + +
Gentisic acid 20mg/dl - - - + + + - - - + + +
Bilirubin 1000mg/dl - - - + + + - - - + + +
Acetylsalicylic Acid 20mg/dl - - - + + + - - - + + +
Acetaminophen 20mg/dl - - - + + + - - - + + +
Caffeine 20mg/dl - - - + + + - - - + + +
Phenylpropanolamine 20mg/dl - - - + + + - - - + + +
Salicylic Acid 20mg/dl - - - + + + - - - + + +
EDTA 20mg/dl - - - + + + - - - + + +
Ethanol 10% - - - + + + - - - + + +
Glucose 20mg/dl - - - + + + - - - + + +
Phenothiazine 20mg/dl - - - + + + - - - + + +
Note: “*” mean negative result, “**” mean positive result
2.2.2. Conclusion
No substances showed any interference with the test. There were no differences observed
between the results at 15 minutes.

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Cross Reactivity
2.3.1. Method
HAV+, HBV+, HCV+, HIV+, RF+, Syphilis+, H.pylori+, Rubella+, Toxo+ and HSV 1/2+ specimens as
confirmed by ELISA and clinical diagnosis were tested with the CMV IgG/IgM Combo Rapid Test
Cassette occurred at 15 minutes after specimen application. Results were presented in Table below.
Table: Cross Reactivity
ICGM-325
Treatment CGM16090007-T CGM16090008-T CGM16090009-T
15mins 15mins 15mins
HAV+ -* - - - - - - - -
HBV+ - - - - - - - - -
HCV+ - - - - - - - - -
HIV+ - - - - - - - - -
RF+ - - - - - - - - -
Syphilis+ - - - - - - - - -
H.pylori+ - - - - - - - - -
Rubella+ - - - - - - - - -
Toxo+ - - - - - - - - -
HSV 1/2+ - - - - - - - - -
Note: “*” mean negative result
2.3.2. Conclusion
There is no cross-reaction with the substance above at 15 minutes.

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Between Day Reproducibility

2.4.1. Method
Negative, CMV IgG low positive, CMV IgM low positive, CMV IgG high positive and CMV IgM high
positive samples were run individually on ten separate days using the same lot of CMV IgG/IgM
Combo rapid test cassettes. Results were rated visually as positive or negative at 15 minutes and
20 minutes after specimen application. Results are presented in table below.
Table: Between Day Results
Lot: CGM16090007-T
Day 1 2 3 4 5 6 7 8 9 10
15mins 10-* 10- 10- 10- 10- 10- 10- 10- 10- 10-
Serum
20mins 10- 10- 10- 10- 10- 10- 10- 10- 10- 10-
Negative 15mins 10- 10- 10- 10- 10- 10- 10- 10- 10- 10-
Plasma
20mins 10- 10- 10- 10- 10- 10- 10- 10- 10- 10-
15mins 10+** 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+
CMV IgG Serum
20mins 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+
Low
15mins 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+
positive Plasma
20mins 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+
15mins 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+
CMV IgG Serum
20mins 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+
high
15mins 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+
positive plasma
20mins 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+
15mins 10+** 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+
CMV Serum
20mins 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+
IgM Low
15mins 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+
positive Plasma
20mins 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+
15mins 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+
CMV Serum
20mins 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+
IgM high
15mins 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+
positive plasma
20mins 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+ 10+
Note: “*” mean all the 10 results were negative “**”mean all the 10 results were positive
2.4.2. Conclusion
Test results for both serum and plasma were consistent over the ten days period.

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Between Lot Reproducibility

2.5.1. Method
Negative, CMV IgG low positive, CMV IgM low positive, CMV IgG high positive and CMV IgM high
positive samples were run in replicates of ten in three separate lots of product. Results were rated
as positive or negative at 15 and 20 minutes after specimen application. The results are present in
table below.
Table: Between Lot Reproducibility Results (Serum)
Negative IgG Low positive IgG High positive
Lot Specimens
15 min 20 min 15 min 20 min 15 min 20 min

1 -* - +** + + +
2 - - + + + +
3 - - + + + +
CGM16090007-T

4 - - + + + +
5 - - + + + +
6 - - + + + +
7 - - + + + +
8 - - + + + +
9 - - + + + +
10 - - + + + +
1 - - + + + +
2 - - + + + +
3 - - + + + +
CGM16090008-T

4 - - + + + +
5 - - + + + +
6 - - + + + +
7 - - + + + +
8 - - + + + +
9 - - + + + +
10 - - + + + +
1 - - + + + +
2 - - + + + +
3 - - + + + +
CGM16090009-T

4 - - + + + +
5 - - + + + +
6 - - + + + +
7 - - + + + +
8 - - + + + +
9 - - + + + +
10 - - + + + +

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Negative IgM Low positive IgM High positive

Lot Specimens
15 min 20 min 15 min 20 min 15 min 20 min

1 -* - +** + + +
2 - - + + + +
3 - - + + + +
CGM16090007-T

4 - - + + + +
5 - - + + + +
6 - - + + + +
7 - - + + + +
8 - - + + + +
9 - - + + + +
10 - - + + + +
1 - - + + + +
2 - - + + + +
3 - - + + + +
CGM16090008-T

4 - - + + + +
5 - - + + + +
6 - - + + + +
7 - - + + + +
8 - - + + + +
9 - - + + + +
10 - - + + + +
1 - - + + + +
2 - - + + + +
3 - - + + + +
CGM16090009-T

4 - - + + + +
5 - - + + + +
6 - - + + + +
7 - - + + + +
8 - - + + + +
9 - - + + + +
10 - - + + + +
Note: “*” mean negative result, “**” mean positive result

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Table: Between Lot Reproducibility Results (Plasma)

Negative IgG Low positive IgG High positive
Lot Specimens
15 min 20 min 15 min 20 min 15 min 20 min

1 -* - +** + + +
2 - - + + + +
3 - - + + + +
CGM16090007-T

4 - - + + + +
5 - - + + + +
6 - - + + + +
7 - - + + + +
8 - - + + + +
9 - - + + + +
10 - - + + + +
1 - - + + + +
2 - - + + + +
3 - - + + + +
CGM16090008-T

4 - - + + + +
5 - - + + + +
6 - - + + + +
7 - - + + + +
8 - - + + + +
9 - - + + + +
10 - - + + + +
1 - - + + + +
2 - - + + + +
3 - - + + + +
CGM16090009-T

4 - - + + + +
5 - - + + + +
6 - - + + + +
7 - - + + + +
8 - - + + + +
9 - - + + + +
10 - - + + + +
Negative IgM Low positive IgM High positive
Lot Specimens
15 min 20 min 15 min 20 min 15 min 20 min

1 -* - +** + + +
CGM1609
0007-T

2 - - + + + +
3 - - + + + +
4 - - + + + +

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5 - - + + + +
6 - - + + + +
7 - - + + + +
8 - - + + + +
9 - - + + + +
10 - - + + + +
1 - - + + + +
2 - - + + + +
3 - - + + + +
CGM16090008-T

4 - - + + + +
5 - - + + + +
6 - - + + + +
7 - - + + + +
8 - - + + + +
9 - - + + + +
10 - - + + + +
1 - - + + + +
2 - - + + + +
3 - - + + + +
CGM16090009-T

4 - - + + + +
5 - - + + + +
6 - - + + + +
7 - - + + + +
8 - - + + + +
9 - - + + + +
10 - - + + + +
Note: “*” mean negative result, “**” mean positive result
2.5.2. Conclusion
Test results were consistent between the 3 lots of CMV IgG/IgM Combo Rapid Test Cassette.

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Accelerated Stability
2.6.1. Method
Accelerated Stability of the CMV IgG/IgM Combo Rapid Cassette (Serum/Plasma) Test was
evaluated using samples from 3 different batches. These were placed in an incubator with the
temperature calibrated at 45℃ and 55℃. Relative humidity (RH) calibrated at about 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, CMV IgG low positive, CMV
IgG medium positive, CMV IgG high positive, CMV IgM low positive, CMV IgM medium positive
and CMV IgM high positive. Testing at each specific time interval consisted of 3 replicates for each
specimen. The tests were performed according to the package insert. Results are presented in
Table below.
Arrhenius Formula:
In K=-Ea/RT + In A
“K” mean Rate constant
“A” mean Arrhenius constant
“Ea” mean Activation energy
“R” mean Gas constant
“T” mean Temperature in Kelvin
Table: Time line for Accelerate Stability Study

Day 14 21 28 35 42 56 77 84
0day 7days
Temp. days days days days days days days days

45℃ √ √ √ √ √ √ √ √ √ √
55℃ √ √ √ √ √ √ √ × × ×

Table: 45℃Accelerated Stability Summary

ICGM-325
Day Specimen
CGM16090007-T CGM16090008-T CGM16090009-T
Negative -* - - - - - - - -
IgG low +** + + + + + + + +
IgG medium + + + + + + + + +
0 IgG high + + + + + + + + +
IgM low + + + + + + + + +
IgM medium + + + + + + + + +
IgM high + + + + + + + + +
7 Negative - - - - - - - - -

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IgG low + + + + + + + + +
IgG medium + + + + + + + + +
IgG high + + + + + + + + +
IgM low + + + + + + + + +
IgM medium + + + + + + + + +
IgM high + + + + + + + + +
Negative - - - - - - - - -
IgG low + + + + + + + + +
IgG medium + + + + + + + + +
14 IgG high + + + + + + + + +
IgM low + + + + + + + + +
IgM medium + + + + + + + + +
IgM high + + + + + + + + +
Negative - - - - - - - - -
IgG low + + + + + + + + +
IgG medium + + + + + + + + +
21 IgG high + + + + + + + + +
IgM low + + + + + + + + +
IgM medium + + + + + + + + +
IgM high + + + + + + + + +
Negative - - - - - - - - -
IgG low + + + + + + + + +
IgG medium + + + + + + + + +
28 IgG high + + + + + + + + +
IgM low + + + + + + + + +
IgM medium + + + + + + + + +
IgM high + + + + + + + + +
Negative - - - - - - - - -
IgG low + + + + + + + + +
IgG medium + + + + + + + + +
35 IgG high + + + + + + + + +
IgM low + + + + + + + + +
IgM medium + + + + + + + + +
IgM high + + + + + + + + +
Negative - - - - - - - - -
IgG low + + + + + + + + +
IgG medium + + + + + + + + +
42 IgG high + + + + + + + + +
IgM low + + + + + + + + +
IgM medium + + + + + + + + +
IgM high + + + + + + + + +
56 Negative - - - - - - - - -

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IgG low + + + + + + + + +
IgG medium + + + + + + + + +
IgG high + + + + + + + + +
IgM low + + + + + + + + +
IgM medium + + + + + + + + +
IgM high + + + + + + + + +
Negative - - - - - - - - -
IgG low + + + + + + + + +
IgG medium + + + + + + + + +
77 IgG high + + + + + + + + +
IgM low + + + + + + + + +
IgM medium + + + + + + + + +
IgM high + + + + + + + + +
Negative - - - - - - - - -
IgG low + + + + + + + + +
IgG medium + + + + + + + + +
84 IgG high + + + + + + + + +
IgM low + + + + + + + + +
IgM medium + + + + + + + + +
IgM high + + + + + + + + +
Note: “*” mean negative result, “**” mean positive result

Table: 55℃ Accelerated Stability Summary

ICGM-325
Day Specimen
CGM16090007-T CGM16090008-T CGM16090009-T
Negative -* - - - - - - - -
IgG low +** + + + + + + + +
IgG medium + + + + + + + + +
0 IgG high + + + + + + + + +
IgM low + + + + + + + + +
IgM medium + + + + + + + + +
IgM high + + + + + + + + +
Negative - - - - - - - - -
IgG low + + + + + + + + +
IgG medium + + + + + + + + +
7 IgG high + + + + + + + + +
IgM low + + + + + + + + +
IgM medium + + + + + + + + +
IgM high + + + + + + + + +
Negative - - - - - - - - -
14
IgG low + + + + + + + + +

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 CMV IGG/IGM COMBO RAPID TEST CASSETTE (SERUM/PLASMA)

IgG medium + + + + + + + + +
IgG high + + + + + + + + +
IgM low + + + + + + + + +
IgM medium + + + + + + + + +
IgM high + + + + + + + + +
Negative - - - - - - - - -
IgG low + + + + + + + + +
IgG medium + + + + + + + + +
21 IgG high + + + + + + + + +
IgM low + + + + + + + + +
IgM medium + + + + + + + + +
IgM high + + + + + + + + +
Negative - - - - - - - - -
IgG low + + + + + + + + +
IgG medium + + + + + + + + +
28 IgG high + + + + + + + + +
IgM low + + + + + + + + +
IgM medium + + + + + + + + +
IgM high + + + + + + + + +
Negative - - - - - - - - -
IgG low + + + + + + + + +
IgG medium + + + + + + + + +
35 IgG high + + + + + + + + +
IgM low + + + + + + + + +
IgM medium + + + + + + + + +
IgM high + + + + + + + + +
Negative - - - - - - - - -
IgG low + + + + + + + + +
IgG medium + + + + + + + + +
42 IgG high + + + + + + + + +
IgM low + + + + + + + + +
IgM medium + + + + + + + + +
IgM high + + + + + + + + +
Note: “*” mean negative result, “**” mean positive result

2.6.2. Conclusion
The CMV IgG/IgM Combo Rapid Test Cassette (Serum/Plasma) 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

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 CMV IGG/IGM COMBO RAPID TEST CASSETTE (SERUM/PLASMA)

3 BIBLIOGRAPHY

1. Starr, S.E. and H.M. Friedman. "Human CMV." Chapter 65. In Manual of Clin. Microbiol., 4th
ed., Lennett, E.H. et al ed. Am. Soc. Microbiol. pp. 771-719, 198
2. Jor MC: Latent infection and the elusive cytomegalovirus. Rev. Infect. Dis. 5:205-215, 1983.
3. Starr SE” cytomegalovirus. Ped. Clin. N. Am. 26:282-293, 1979.

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