OnSite Typhoid IgG/IgM2.

0 Rapid Test-Cassette (Serum / Plasma) Page 1 of 2

OnSite® Typhoid IgG/IgM2.0 Rapid Test

clinical specimens. Wash hands thoroughly after performing the test.
8. Users of this test should follow the US CDC Universal Precautions for prevention of
transmission of HIV, HBV and other blood-borne pathogens.
9. Do not smoke, drink, or eat in areas where specimens or kit reagents are being
R0160C handled.
10. Dispose of all specimens and materials used to perform the test as biohazardous
waste.
Instructions for Use 11. Handle the Negative and Positive Control in the same manner as patient specimens.
12. The test results should be read 15 minutes after a specimen is applied to the sample
INTENDED USE well or sample pad of the device. Any results interpreted outside of the 15 minutes
The OnSite Typhoid IgG/IgM2.0 Rapid Test is a lateral flow immunoassay for the qualitative window should be considered invalid and must be repeated.
detection and differentiation of anti-Salmonella typhi (S. typhi) and paratyphi IgG and IgM in 13. Do not perform the test in a room with strong air flow, i.e. an electric fan or strong air-
human serum or plasma. It is intended to be used by healthcare professionals to aid in the conditioning.
diagnosis of infection with S. typhi and paratyphi. REAGENT PREPARATION AND STORAGE INSTRUCTIONS
Any use or interpretation of this preliminary test result must also rely on other clinical findings All reagents are ready to use as supplied. Store unused test device unopened at 2-30°C. If
and the professional judgment of health care providers. Alternative test method(s) should be stored at 2-8°C, ensure that the test device is brought to room temperature before opening. The
considered to confirm the test result obtained by this device. test device is stable through the expiration date printed on the sealed pouch. Do not freeze the
SUMMARY AND EXPLANATION OF THE TEST kit or expose the kit to temperature above 30°C.

Typhoid fever and paratyphi fever are bacterial infections caused by Salmonella typhi and SPECIMEN COLLECTION AND HANDLING
paratyphi A, B, and C respectively, which are transmitted through the ingestion of tainted food Consider any materials of human origin as infectious and handle them using standard bio-safety
and water. Worldwide an estimated 17 million cases and 600,000 associated deaths occur procedures.
annually1. Patients who are infected with HIV are at significantly increased risk of clinical
infection. 1-5% of patients become chronic carriers harboring S. typhi in the gallbladder. Plasma/Serum
Step 1: Collect blood specimen into collection tube containing EDTA, citrate or heparin for
The clinical diagnosis of infections depends on isolation of S. typhi and paratyphi from blood,
plasma or collection tube containing no anticoagulants for serum by venipuncture.
bone marrow or a specific anatomic lesion. In facilities that can not afford to perform this
Step 2: To make plasma specimen, centrifuge collected specimens and carefully withdraw the
complicated and time-consuming procedure, Filix-Widal test is used to facilitate diagnosis.
plasma into a new pre-labeled tube.
However, many limitations lead to difficulties in the interpretation of the Widal test3,4.
Step 3: To make serum specimen, allow blood to clot, then centrifuge collected specimens
In contrast, the OnSite Typhoid IgG/IgM2.0 Rapid Test is a simple, fast laboratory test that and carefully withdraw the serum into a new pre-labeled tube.
simultaneously detects and differentiates IgG and IgM antibodies to S. typhi and paratyphi
Test specimens as soon as possible after collecting. Store specimens at 2-8°C, if not tested
antigen5 thus aiding in the determination of current or previous exposure to S. typhi and
immediately. The specimens can be stored at 2-8°C for up to 5 days. The specimens should be
paratyphi. IgM positive or IgM /IgG both positive suggest current infection, while IgG positive
frozen at -20°C for longer storage.
suggests late stage of infection, previous infection, or latent infection.
Avoid multiple freeze-thaw cycles. Prior to testing, bring frozen specimens to room temperature
TEST PRINCIPLE
slowly and mix gently. Specimens containing visible particulate matter should be clarified by
The OnSite Typhoid IgG/IgM2.0 Rapid Test is a centrifugation before testing.
lateral flow chromatographic immunoassay. The
Do not use samples demonstrating gross lipemia, gross hemolysis or turbidity in order to avoid
test cassette consists of: 1) a colored conjugate
interference with result interpretation.
pad containing recombinant H antigen and O
antigen conjugated with colloidal gold (HO ASSAY PROCEDURE
conjugates) and a control antibody conjugated
with colloidal gold, 2) a nitrocellulose membrane Step 1: Bring the specimen and test components to room temperature, if refrigerated or
strip containing two test lines (G and M lines) and frozen. Once thawed, mix the specimen well prior to performing the assay.
a control line (C line). The M line is pre-coated with monoclonal anti-human IgM for the detection Step 2: When ready to test, open the pouch at the notch and remove device. Place the test
of anti-S. typhi and paratyphi IgM, G line is pre-coated with reagents for the detection of anti-S. device on a clean, flat surface.
typhi and paratyphi IgG, and the C line is pre-coated with a control line antibody.
Step 3: Be sure to label the device with specimen’s ID number.
When an adequate volume of test specimen is dispensed into the sample well of the cassette,
the test specimen migrates by capillary action across the test cassette. IgM antibodies if present Step 4: Fill the plastic dropper with the specimen.
in the patient specimen will bind to the HO conjugates. The immunocomplex is then captured on
the membrane by the pre-coated anti-human IgM antibody, forming a colored M line, indicating Holding the dropper vertically, dispense 1 drop (about 30-45 μL) of serum/plasma into
an anti-S. typhi or paratyphi IgM positive test result. the center of the sample well, making sure that there are no air bubbles.

IgG antibodies if present in the patient specimen will bind to the HO conjugates. The Then immediately add 1 drop (about 35-50 µL) of sample diluent into the center of the
immunocomplex is then captured by the pre-coated reagents on the membrane, forming a sample well with the bottle positioned vertically.
colored G line, indicating an anti-S. typhi or paratyphi IgG positive test result.

Absence of any test lines (M and G) suggests a negative result. The test contains an internal
control (C line) which should exhibit a colored line of the immunocomplex of the control Result
antibodies regardless of the color development on any of the test lines. Otherwise, the test result 15 minutes
is invalid and the specimen must be retested with another device.

REAGENTS AND MATERIALS PROVIDED

1. Individually sealed foil pouches containing: 1 drop of serum/plasma 1 drop of sample diluent
a. One cassette device
b. One desiccant
2. Plastic droppers Step 5: Set up timer.
3. Sample diluent (REF SB-R0160, 5 mL/bottle)
Step 6: Results should be read at 15 minutes. Positive results may be visible in as short as 1
4. Instructions for use
minute. Negative results must be confirmed at the end of the 15 minutes only. Any
MATERIALS MAY BE REQUIRED AND NOT PROVIDED results interpreted outside of the 15 minute window should be considered
invalid and must be repeated. Discard used devices after interpreting the result
1. Positive Control following local requirements governing the disposal of devices.
2. Negative Control
QUALITY CONTROL
MATERIALS REQUIRED BUT NOT PROVIDED
1. Internal Control: This test contains a built-in control feature, the C line. The C line
1. Clock or timer develops after adding specimen and sample diluent. Otherwise, review the whole
procedure and repeat test with a new device.
WARNINGS AND PRECAUTIONS
2. External Control: Good Laboratory Practice recommends using external controls,
For In Vitro Diagnostic Use
1. Read these Instructions for Use completely before performing the test. Failure to follow positive and negative, to assure the proper performance of the assay, particularly
the instructions could lead to inaccurate test results. under the following circumstances:
2. Do not open the sealed pouch, unless ready to conduct the assay. a. A new operator uses the kit, prior to performing testing of specimens.
3. Do not use expired devices. b. A new lot of test kit is used.
4. Bring all reagents to room temperature (15-30°C) before use. c. A new shipment of kits is used.
5. Do not use the components in any other type of test kit as a substitute for the components d. The temperature used during storage of the kit falls outside of 2-30°C.
in this kit. e. The temperature of the test area falls outside of 15-30°C.
6. Do not use hemolyzed blood specimen for testing. f. To verify a higher than expected frequency of positive or negative results.
7. Wear protective clothing and disposable gloves while handling the kit reagents and g. To investigate the cause of repeated invalid results.

Copyright 2021 by CTK Biotech, Inc.

 OnSite Typhoid IgG/IgM2.0 Rapid Test-Cassette (Serum / Plasma) Page 2 of 2

INTERPRETATION OF ASSAY RESULT 2. The OnSite Typhoid IgG/IgM2.0 Rapid Test is limited to the qualitative detection of
antibodies to S. typhi or paratyphi in human serum or plasma. The intensity of the test
1. NEGATIVE OR NON-REACTIVE RESULT: If only the C line is present, the absence of line does not have linear correlation with the antibody titer in the specimen.
any color in the both test lines (M and G) indicates that no anti-S. typhi or paratyphi 3. A negative or non-reactive result for an individual subject indicates absence of detectable
antibody is detected in the specimen. The result is negative or non-reactive. anti-S. typhi or paratyphi antibodies. However, a negative test result does not preclude
the possibility of exposure to S. typhi or paratyphi.
4. A negative or non-reactive result can occur if the quantity of anti-S. typhi or paratyphi
S antibodies present in the specimen is below the detection limit of the assay, or the
antibodies that are detected are not present during the stage of disease in which a sample
is collected.
5. Infection may progress rapidly. If the symptom persists, while the result from OnSite
2. POSITIVE OR REACTIVE RESULT: Typhoid IgG/IgM2.0 Rapid Test is negative or non-reactive result, it is recommended to
2.1 In addition to the presence of C line, if only M line develops, the test indicates for the test with an alternative test method, such as bacterial culture method.
presence of anti-S. typhi or paratyphi IgM in the specimen. The result is IgM positive or 6. Some specimens containing unusually high titer of heterophile antibodies or rheumatoid
reactive. factor may affect expected results.
7. The results obtained with this test should only be interpreted in conjunction with other
diagnostic procedures and clinical findings.
S S
REFERENCES

1. Ivanoff BN, Levine MM, Lambert PH. Vaccination against typhoid fever: present status.
2.2 In addition to the presence of C line, if only G line develops, the test indicates for the Bulletin of the World Health Organization 1994; 72: 957-71.
presence of anti-S. typhi or paratyphi IgG in the specimen. The result is IgG positive or 2. Gotuzzo E, Frisancho O, Sanchez J, Liendo G, Carillo C, Black RE, Morris JG.
reactive. Association between the acquired immunodeficiency syndrome and infection with
Salmonella typhi or Salmonella paratyphi in an endemic typhoid area. Archives of Internal
Medicine 1991; 151: 381-2.
3. Clegg A, Passey M, Omena MK, et al. Re-evaluation of the Widal agglutination test in
S S
response to the changing pattern of typhoid fever in the highlands of Papua New Guinea.
Acta Tropica 1994; 57:255-63.
4. Pang T. False positive Widal test in nontyphoid Salmonella infection. Southeast Asian
Journal of Tropical Medicine and Public Health 1989; 20: 163-4.
2.3 In addition to the presence of C line, both M and G lines develop, the test indicates for 5. Ismail A, Hai OK, Kader ZA. Demonstration of an antigenic protein specific for Salmonella
the presence of anti-S. typhi or paratyphi IgG and IgM in the specimen. The result is both typhi. Biochem Biophys Res Commun. 1991;181(1):301-5.
IgG and IgM positive or reactive.
Index of Symbols
Consult For in vitro
S S , treatment
instructions for use diagnostic use only Use by

Catalog # Lot Number N Tests per kit

Authorized
Samples with positive or reactive results should be confirmed with alternative testing Store between 2-30°C Do not reuse
Representative
method(s) and clinical findings before a diagnosis decision is made.
Manufacturer Date of manufacture
3. INVALID: If no C line develops, the assay is invalid regardless of any color in the test
lines as indicated below. Repeat the assay with a new device.

SIMPLIFYING DIAGNOSTICS

S S MDSS GmbH
CTK Biotech, Inc.
Schiffgraben 41
13855 Stowe Drive
30175 Hannover, Germany
Poway, CA 92064, USA
Tel: 858-457-8698
Fax: 858-535-1739
S S E-mail: info@ctkbiotech.com

PI-R0160C Rev. H2.0

Date released: 2021-06-03
English version
PERFORMANCE CHARACTERISTICS
For Export Only, Not For Re-sale in the USA
1. Clinical Performance for IgM Test
A total of 334 specimens were collected from susceptible subjects and tested by the
OnSite Typhoid IgG/IgM2.0 Rapid Test and by a commercial S. typhi IgM EIA. Comparison
for all subjects is shown in the following table:
OnSite Typhoid IgG/IgM2.0 Rapid Test
IgM EIA Positive Negative Total
Positive 31 3 34
Negative 2 298 300
Total 33 301 334
Relative Sensitivity: 91%, Relative Specificity: 99.3%, Overall Agreement: 98.5%

2. Clinical Performance for IgG Test

A total of 314 specimens were collected from susceptible subjects and tested by the
OnSite Typhoid IgG/IgM2.0 Rapid Test and by a commercial S. typhi IgG EIA kit.
Comparison for all subjects is shown in the following table.
OnSite Typhoid IgG/IgM2.0 Rapid Test
IgG EIA Positive Negative Total
Positive 13 1 14
Negative 2 298 300
Total 15 299 314
Relative Sensitivity: 92.9%, Relative Specificity: 99.3%, Overall Agreement: 99.0%

3. Performance Comparison with Blood Culture

Nine (9) S. paratyphi A positive and eleven (11) S. typhi positive specimens confirmed
with the blood culture were tested with the OnSite Typhoid IgG/IgM2.0 Rapid Test. The
OnSite Typhoid IgG/IgM2.0 Rapid Test correctly indentified 9 S. paratyphi A and 10 S.
typhi specimens. The agreement was 95%.

LIMITATIONS OF TEST

1. The Assay Procedure and the Test Result Interpretation must be followed closely when
testing the presence of antibodies to S. typhi or paratyphi in serum or plasma from
individual subjects. Failure to follow the procedure may give inaccurate results.

Copyright 2021 by CTK Biotech, Inc.