AccuBiotech Co., Ltd.
Accurate, Reliable, Cost Effective
® to the HSV-2 conjugates. The immunocomplex is then captured on
ACCU-TELL
HSV-2 IgG/IgM Cassette
(Serum/Plasma)
For professional in vitro diagnostic Use only
For Serum/Plasma Samples
This package insert is applied to the below products:
Catalog No. Product Name
ABT-FT-B310 HSV-2 IgG/IgM Cassette (Serum/Plasma)
A rapid test for the qualitative detection of IgG and IgM antibodies to
HSV-2 in human serum or plasma
For professional in vitro diagnostic use only
INTENDED USE
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ACCU-TELL HSV-2 IgG/IgM Cassette (Serum/Plasma) is a lateral
flow chromatographic immunoassay for the qualitative detection of
IgG and IgM antibodies to HSV-2 in serum or plasma to aid in the
diagnosis of HSV-2 infection.
SUMMARY
Herpes Simplex Virus (HSV) is a common pathogen of humans.
There are two distinct types of HSV: Types 1 and 2. HSV-1 is usually
associated with infection in the oropharyngeal area and eyes while
1,2
HSV-2 causes mostly genital and neonatal infections. However, the
3
tissue specificity is not absolute. Both HSV-1 and HSV-2 can be
found at either site of infection without being specific for one region,
i.e., either genital or oropharynx.. Neonatal HSV infection may
remain localized or become disseminated. Localized infection may
involve skin, eyes, mouth or central nervous system. The infants with
neonatal HSV bear the risk of developing severe neurological or
ocular sequelae. Detection of antibodies to HSV has been
acknowledged to be a screening method for HSV infections. The
methods for such antibodies detection include complement fixation,
indirect immunofluorescent antibody, plaque neutralization, and
ELISA. Antibody of the IgM class is produced during the first 2-3
weeks of infection with HSV and exists only transiently in most
patients. The detection of IgM antibodies against HSV help
discriminates between primary and recurrent infections.
The detection of anti-HSV-2 IgM antibodies enables effective
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diagnosis of acute or recent HSV-2 infection. ACCU-TELL HSV-2
IgG/IgM Cassette (Serum/Plasma) is a rapid chromatographic
immunoassay for the qualitative detection of IgG and IgM antibodies
to HSV-2 in serum or plasma specimens.
PRINCIPLE
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ACCU-TELL HSV-2 IgG/IgM Test Cassette (Serum/Plasma) is a
qualitative, lateral flow immunoassay for the detection of IgM
antibodies to HSV-2 in serum or plasma specimens. The test
consists of: 1) a colored conjugate containing recombinant HSV-2
antigens conjugated with colloid gold (HSV-2 conjugates) and mouse
IgG-gold conjugates, 2) a nitrocellulose membrane strip containing a
test band (T band) and a control band (C band). The IgG band is pre-
coated with monoclonal anti-human IgG for detection of IgG anti-
HSV-2, IgM band is pre-coated with polyclonal anti-human IgM for
detection of IgM anti-HSV-2, and the C band is pre-coated with goat
anti mouse IgG.
When an adequate volume of test specimen is applied into the
sample pad of the test, the specimen migrates by capillary action
across the strip. IgG anti-HSV-2 if present in the specimen will bind
to the HSV-2 conjugates. The immunocomplex is then captured on
the membrane by the pre-coated anti-human IgG antibody, forming a
colored IgG band, indicating a HSV-2 IgG positive test result.
When an adequate volume of test specimen is applied into the
sample pad of the test, the specimen migrates by capillary action TEST PROCEDURE
across the strip. IgM anti-HSV-2 if present in the specimen will bind1.
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ACCU-TELL HSV-2 IgG/IgM Cassette (Serum/Plasma)
the membrane by the pre-coated anti-human IgM antibody, forming a
colored IgM band, indicating a HSV-2 IgM positive test result.
Absence of T band suggests a negative result. The test contains an
internal control (C band) which should exhibit a colored band of the
immunocomplex of goat anti mouse IgG/mouse IgG-gold conjugate
regardless of the color development on the T band. Otherwise, the
test result is invalid and the specimen must be retested with another
device.
To serve as a procedural control, a colored line will always appear in
the control line region of the strip indicating that proper volume of
specimen has been added and membrane wicking has occurred.
REAGENTS
The test contains goat anti-human IgM, mouse anti-human IgG and
HSV-2 antigen. A goat antibody is employed in the control line
system.
PRECAUTIONS
1. For in vitro diagnostic use only. Do not use after the expiration
date.
2. Do not smoke, drink, or eat in areas where specimens or kits
reagents are handled.
3. This package insert must be read completely before performing
the test.
4. Bring all reagents to room temperature (15℃-30℃) before use.
5. Wear protective clothing such as laboratory coats, disposable
gloves and eye protection when specimens are assayed.
6. The used tests, specimens and potentially contaminated materials
should be discarded according to the local regulations.
7. Humidity and temperature can adversely affect results.
STORAGE AND STABILITY
Store as packaged in the sealed pouch at room temperature or
refrigerated (2-30°C). The test is stable through the expiration date
printed on the sealed pouch. The test must remain in the sealed
pouch until use. DO NOT FREEZE. Do not use beyond the
expiration date.
SPECIMEN COLLECTION AND PREPARATION
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1. ACCU-TELL HSV-2 IgG/IgM Cassette (Serum/Plasma) can be
performed using serum or plasma.
2. Separate the serum or plasma from blood as soon as possible to
avoid hemolysis. Only clear, non-hemolyzed specimens can be
used.
3. 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.
4. 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.
5. Bring specimens to room temperature prior to test avoid
hemolysis or turbidity.
6. If specimens are to be shipped, they should be packed in
compliance with local regulations.
MATERIALS
Materials provided
Test cassettes
Droppers
Package insert
Materials required but not provided
 Centrifuge
 Specimen collection contain
Timer
Bring the pouch to room temperature before opening it.
Version #: HBT-5272903
Effective Date: 2022-07
 AccuBiotech Co., Ltd. Accurate, Reliable, Cost Effective
Remove the test cassette from the sealed pouch and use it within conjunction with other diagnostic procedures and clinical findings.
one hour. Best results will be obtained if the assay is performed
within one hour. EXPECTED VALUES
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2. Place the test cassette on a clean and level surface. Hold ACCU-TELL HSV-2 IgG/IgM Cassette (Serum/Plasma) has been
the dropper vertically and transfer 1 drops of serum or plasma compared with a leading commercial HSV-2 IgG/IgM ELISA test. The
(Approx.25ul) and 2 drops of buffer to the specimen well of the test correlation between these two systems is over 98%.
cassette. Avoid trapping air bubbles in the specimen well. See the
illustration below. PERFORMANCE CHARACTERISTICS
3. Wait for the colored line(s) to appear. The result should be Sensitivity and Specificity
read at 15 minutes. Do not interpret results after 15minutes. A clinical evaluation was conducted comparing the results obtained
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using ACCU-TELL HSV-2 IgG/IgM Cassette (Serum/Plasma) to
HSV-2 IgG/IgM ELISA Testing. The study included 233 IgG
specimens and 220 IgM specimens.
IgG Results
Method HSV-2 ELISA (IgG) Total
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ACCU-TELL Results Positive Negative Results
HSV-2 IgG/IgM Positive 30 1 31
Cassette for IgG Negative 3 199 202
Total Results 33 200 233
Sensitivity: 90.9% (95%CI*:75.7%~98.1%)
Specificity: 99.5% (95%CI*:97.2%~99.9%)
Accuracy: 98.3 % (95%CI*:95.7%~99.5%)
INTERPRETATION OF RESULTS *Confidence Interval
(Please refer to the illustration above) IgM Results
POSITIVE:* Two or three lines appear. One colored line should
Method HSV-2 ELISA (IgM) Total
always appear in the control line region (C) and another one or two ®
ACCU-TELL Results Positive Negative Results
apparent colored line(s) should be in the test line region(s) (IgM
HSV-2 IgG/IgM Positive 18 0 18
and/or IgG).
Cassette for IgM Negative 2 200 202
IgM Positive: Along with line in Control region (C), a line appears in
IgM region. It indicates a positive Test result for antibodies to HSV-2 Total Results 20 200 220
IgM Sensitivity: 90.0%(95%CI*:68.3%-98.8%)
IgG Positive: Along with line in Control region (C), a line appears in Specificity: 100.0% (95%CI*: 98.5%~100%)
IgG region. It indicates a positive Test result for antibodies to HSV-2 Accuracy: 99.1% (95%CI*: 96.8%~99.9%)
IgG *Confidence Interval
*NOTE: The intensity of the color in the test line regions (IgM and Precision
IgG) may vary depending on the concentration of HSV-2 antibodies Intra-Assay
present in the specimen. Therefore, any shade of color in the test Within-run precision has been determined by using 10 replicates of
line region (IgM and/or IgG) should be considered positive. three specimens: a negative, a low positive, and a high positive. The
NEGATIVE: One colored line appears in the control line region negative, low positive, and high positive values were correctly
(C). No line appears in the test line regions (IgM and IgG). identified >99% of the time.
INVALID: Control line fails to appear. Insufficient specimen volume Inter-Assay
or incorrect procedural techniques are the most likely reasons for Between-run precision has been determined by 10 independent
control line failure. Review the procedure and repeat the test with a assays on the same three specimens: a negative, a low positive, and
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new test. If the problem persists, discontinue using the test kit a high positive. Three different lots of ACCU-TELL HSV-2 IgG/IgM
immediately and contact your local distributor. Cassette (Serum/Plasma) have been tested over a 3-day period
using negative, low positive, and high positive specimens. The
QUALITY CONTROL specimens were correctly identified >99% of the time.
Internal procedural controls are included in the test. A colored line Cross-reactivity
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appearing in the control region (C) is an internal positive procedural ACCU-TELL HSV-2 IgG/IgM Cassette (Serum/Plasma) has been
control. tested for HBsAg, HBsAb, HbeAg, HBeAb, HBcAb, HCV, HIV,
Syphilis, H. Pylori, CMV and Rubella positive specimens. The results
LIMITATIONS showed no cross-reactivity.
1. The Assay Procedure and the Test Result Interpretation must be Interfering Substances
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followed closely when testing the presence of antibodies to HSV-2 The following compounds have also been tested using ACCU-TELL
in serum or plasma from individual subjects. Failure to follow the HSV-2 IgG/IgM Cassette (Serum/Plasma) and no interference was
procedure may give inaccurate results. observed.
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2. ACCU-TELL HSV-2 IgG/IgM Cassette (Serum/Plasma) is limited Ascorbic Acid: 20mg/ml
to the qualitative detection of the antibodies to HSV-2 in human Hemoglobin: 1000mg/dl
serum or plasma. The intensity of the test band does not linear Gentisic Acid: 20 mg/dL
correlation with the antibody titer in the specimen. Oxalic Acid: 60mg/dL
3. A negative result for an individual subject indicates absence of Bilirubin: 1000mg/dL
detectable HSV-2 antibodies. However, a negative test result does Uric acid: 20mg/ml
not preclude the possibility of exposure to or infection with HSV-2. Acetaminophen: 20 mg/dL
4. A negative result can occur if the quantity of the HSV-2 antibodies Aspirin: 20mg/dl
present in the specimen is below the detection limits of the assay, Methanol: 10%
or the antibodies that are detected are not present during the stage Creatine: 200mg/dl
of disease in which a sample is collected Albumin: 2 g/dL
5. Some specimens containing unusually high titer of heterophile Caffeine: 20 mg/dl
antibodies or rheumatoid factor may affect expected results. BIBLIOGRAPHY
6. The results obtained with this test should only be interpreted in 1. Bosma T.J. Corbett KM, O’Shea S. Banatvala .W. Best JM.
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ACCU-TELL HSV-2 IgG/IgM Cassette (Serum/Plasma) Effective Date: 2022-07
 AccuBiotech Co., Ltd. Accurate, Reliable, Cost Effective
PCR for desection of rubella virus RNA in clinical smaples. J Clin
Mcrobiol 1995; 33:1075-9 Thomas HIJ, lslorgan-Capner P, Connor
NS. Adaptation of commercial rubella specific
2. IgG kit to assess specific IgG avidity. Serodiagn Immunother
Infect Disease 1993.1:13-6.
3. Mellinger AK, Cragan ID. Atkinson WL et al. High incidence of
congenital rubella syndrome after a rubella outbreak. Pedi~tr Infect
Dis J 1995:14:573-5

GLOSSARY OF SYMBOLS
Temperature
Catalog number
limitation
Consult instructions for
Batch code
use
In vitro diagnostic
Use by
medical device
Manufacturer Do not reuse

AccuBioTech Co., Ltd.

Building 4, Maohua Industry Park, No. 1, CAIDA Third Street,
Nancai Town, Shunyi District, 101399, Beijing, P.R.China
Tel: 0086 10 80484980 Web: www.accubiotech.com

Page 3 of 3 Version #: HBT-5272903

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ACCU-TELL HSV-2 IgG/IgM Cassette (Serum/Plasma) Effective Date: 2022-07