RESZON® Strongyloidiasis IgG4 Rapid Test
This webpage content is intended for Healthcare Professionals only, not for general public. Registered under Act 737
MDA Registration Number: IVDC7526826-233770
- Rapid immunochromatography assay for qualitative detection of specific IgG4 antibodies to Strongyloides stercoralis
- Specimen: Human whole blood, serum, plasma
- Fast result within 15-25 minutes
- Simple to perform & no special equipment required
For professional in vitro diagnostic use only.
TEST KIT SPECIFICATION
| Platform | Immunochromatographic Assay |
| Format | Cassette |
| Detection | Specific IgG4 antibodies to Strongyloides stercoralis |
| Specimen | Human whole blood, serum & plasma |
| Specimen volume | 35 μl |
| Sensitivity | 96.6% |
| Specificity | 91.2% |
| Storage | 2-30°C |
| Shelf Life* | 24 months |
*From date of manufacture
WHAT IS STRONGYLOIDIASIS?
Strongyloidiasis is a chronic human parasitic infection mainly caused by Strongyloides stercoralis, a soil-transmitted helminth (STH) capable of persisting in the human host for decades through a unique autoinfection cycle. This ability allows larvae to reinvade the host without external re-exposure, making strongyloidiasis fundamentally different from other STH infections and a major reason it often remains undetected for years.
Globally, strongyloidiasis was estimated to affect 613.9 million people in 2017, with the highest burden reported in tropical and subtropical regions. The South-East Asia, African, and Western Pacific regions together accounted for approximately 76.1% of global infections.
Many infected individuals develop chronic, asymptomatic infections that may persist for decades – or even a lifetime – because of the parasite’s ability to autoinfect. Of particular concern is the risk of progression to hyperinfection syndrome or disseminated strongyloidiasis following immunosuppression, especially with corticosteroid therapy. Therefore, screening for Strongyloides infection is recommended before initiating immunosuppressive therapy in individuals at risk of infection.
WHY CHOOSE RESZON® STRONGYLOIDIASIS IgG4
RAPID TEST KIT?
High Diagnostic Performance for Accurate Detection
- Sensitivity: 96.6% supports early detection
- Specificity: 91.2% reliable screening results
Proven Performance Across Diverse Settings
- Evaluated across multiple countries (Switzerland, Thailand, Iran, Malaysia) and populations2,3,4,5
- Demonstrates good and consistent performance
- Suitable for diagnosis, screening, and public health programs
Suitable for Clinically Challenging Cases, such as Patients with:
- Unexplained eosinophilia
- Chronic gastrointestinal symptoms
- Recurrent or unexplained skin manifestations
- Asthma or respiratory symptoms with eosinophilia
- Unexplained Gram-negative sepsis
Fast Results
- Within 15 minutes (serum/plasma samples)
- Within 25 minutes (whole blood samples)
WHO ARE AT HIGHER RISK OF SEVERE DISEASE
(HYPERINFECTION/DISSEMINATED STRONGYLOIDIASIS)?
IMMUNOSUPPRESSED INDIVIDUALS
- Patients infected with human immunodeficiency virus (HIV) or human T-lymphotropic virus type 1 (HTLV-1)
- Patients receiving chemotherapy for cancer
- Solid organ transplant recipients
- Hematopoietic stem cell (bone marrow) transplant recipients
- Advanced chronic kidney disease (CKD)
- Patients with autoimmune or inflammatory diseases receiving immunosuppressive drugs (e.g. rheumatoid arthritis)
- Patients with severe malnutrition or other causes of impaired cellular immunity
PATIENTS RECEIVING CORTICOSTEROID THERAPY
Both short-term and long-term systemic corticosteroid therapy
can increase the risk of Strongyloides hyperinfection syndrome
PATIENTS WITH HAEMATOLOGICAL MALIGNANCIES
- Leukemia
- Lymphoma and other haematological malignancies
INTENDED USERS & CLINICAL APPLICATIONS
HOSPITALS & CLINICAL LABORATORIES
routine and pre-immunosuppression screening
PRIMARY CARE & COMMUNITY CLINICS
rapid, on-site clinical decision support
PUBLIC HEALTH & SCREENING PROGRAMS
population-level surveillance and control
MIGRANT, REFUGEE & TRAVEL MEDICINE CLINICS
migrants, refugees, and travellers with endemic exposure
TRANSPLANT & ONCOLOGY CENTRES
risk mitigation before immunosuppressive therapy
NGOs & OUTREACH TEAMS
field screening in resource-limited settings
RESEARCH & ACADEMIC INSTITUTIONS
epidemiology studies
|
Cat. No. |
Product Description |
Test Specimen* |
Product Format |
Intended Use |
Intended Use |
Storage Temp. |
Packing Size |
|---|---|---|---|---|---|---|---|
|
RSS-RD0101-25 |
RESZON® Strongyloidiasis IgG4 Rapid Test Rapid Test |
S/P/WB |
Cassette |
Detection of specific IgG4 antibodies to Strongyloides stercoralis |
For Professional Use |
2-30oC |
25 T/ Kit |
|
RSS-RD0101A-25 |
RESZON® Strongyloidiasis IgG4 Rapid Test Rapid Test (with disposable dropper) |
S/P/WB |
Cassette |
Detection of specific IgG4 antibodies to Strongyloides stercoralis |
For Professional Use |
2-30oC |
25 T/ Kit |
|
RSS-RD0101B-25 |
RESZON® Strongyloidiasis IgG4 Rapid Test (with disposable dropper, alcohol swab and lancet) |
S/P/WB |
Cassette |
Detection of specific IgG4 antibodies to Strongyloides stercoralis |
For Professional Use |
2-30oC |
25 T/ Kit |
* S – Serum; P – Plasma; WB – Whole Blood; T – Test
References:
- Ashiri, A., Rafiei, A., Noordin, R., Anuar, S.A., Teimoori, A., Ansari-Moghaddam, B., Beiromvand, M. (2025) Strongyloides stercoralis prevalence and diagnostic efficacy of an IgG4 rapid test in an eosinophilic population in Khuzestan Province, southwestern Iran. Parasit Vectors 18, 291.
- Nickel B, Krebs C, Ruf MT, Anuar NS, Noordin R. (2024) An evaluation of a lateral flow rapid diagnostic test for Strongyloides stercoralis infection. Acta Trop. 2024; 258:107336.
- Wongphutorn P, Noordin R, Anuar NS, Worasith C, Kopolrat KY, Homwong C, Tippayawat P, Techasen A, Pitaksakurat O, Sithithaworn J, Eamudomkarn C, Sithithaworn P. (2024) Examination of Diagnostic Performance of New IgG4 Rapid Test Compared with IgG- and IgG4-ELISAs to Investigate Epidemiology of Strongyloidiasis in Northeast Thailand. Am J Trop Med Hyg 2024; 110(2):254-262.
- Noordin R, Osman, Kalantari N, Anuar NS, Gorgani-Firouzjaee T, Sithithaworn P, Juri NM, Rahumatullah A. (2022) A point-of-care cassette test for detection of Strongyloides stercoralis. Acta Tropica 2022; 226:106251.
- Tamarozzi F, Guevara ÁG, Anselmi M, Vicuña Y, Prandi R, Marquez M, Vivero S, Robinzón Huerlo F, Racines M, Mazzi C, Denwood M, Buonfrate D. (2023) Accuracy, acceptability, and feasibility of diagnostic tests for the screening of Strongyloides stercoralis in the field (ESTRELLA): a cross-sectional study in Ecuador. Lancet Glob Health. 2023 May;11(5):e740-e748.
Frequently Asked Questions (FAQ)
BEFORE RUNNING THE TEST
1. Can I use the test device if the pouch is damaged or there is broken/ incomplete seal?
No. Do not use the test device if the pouch is damaged or the seal is broken/ incomplete. Please use a new test.
2. Can I use the test device if there is no desiccant in the pouch?
No. Desiccant should come together with test device in the pouch. Please use a new test.
3. Can I use the kit beyond its expiry date?
No. User should not use the test beyond the expiry date shown on the test kit labelling.
WHILE RUNNING THE TEST
4. Can I use specimen directly from the refrigerator?
No. Refrigerated specimen should be equilibrated to room temperature (about 30 minutes) or between 15oC and 30oC before being tested. Remember to mix the specimen before use.
5. Can I use whole blood sample from finger prick?
Yes. Whole blood sample from finger prick can be used. However, skillful professional user and a suitable lancet are required to ensure su cient specimen can be collected. It is highly recommended to use whole blood
sample from venipuncture.
6. I found that the bu ffer is not enough to run the test in the kit. Can I use bu ffer from other brand?
No. Bu ffer from other brand cannot be used as a substitute for the buff er in this kit. Please contact your supplier for assistance. The bu ffer provided in the kit are more than the actual volume needed to run all 25 tests in the kit. User should check the IFU again and ensure that the tests are run following the correct assay procedure.
7. Can I put more sample to the test? What if I accidentally added more sample to the test?
No. User should follow the instruction of the assay procedure strictly. Failure to follow the instruction may give inaccurate test results. Repeat the test if the sample volume is incorrect during the testing.
8. Why is it the sample never flow up, or the sample only flow half of the test window?
It may be due to insuffi cient specimen or bu ffer volume. Suffi cient amount of specimen and buff er are important to ensure the sample to flow up properly. Please repeat the test with a new test device if invalid results observed. When adding buff er, it is important to hold the bu er
tube vertically, carefully press the tube to release full drop of bu ffer, one drop by one drop. The droplet volume of the bu ffer may be inconsistent if the buff er tube is not held vertically above the well “2”, or buff er being released too fast.
9. Can we add more bu ffer if the sample is not flowing up?
No. The assay procedures need to be followed strictly. If no sample flow is observed, check again the procedure and repeat the test with a new test device.
10. Can I read results before 20 minutes?
For whole blood samples, read the result within 25 minutes. For serum or plasma samples, read the result within 15 minutes.
11. Can I read results after 30 minutes?
No. Do not read results after 30 minutes. Results read after 30 minutes may lead to a false positive, false negative, or invalid result.
INTERPRETATION OF RESULTS
12. What do the results mean?
If coloured bands appear at the control line (C) and test line (T), it indicates a positive result. Positive results indicate the presence of specific Strongyloides IgG4 antibodies in the specimen. Positive result should not be used as the sole criteria for the diagnosis of Strongyloides infection. Positives results should be confirmed by alternative testing method and clinical finding before positive determination is made.
The result is negative if only control line (C) is visible with no coloured line developed at test line (T) position. This indicates that specific Strongyloides IgG4 antibody has not been detected. Negative result does not preclude the possibility of exposure to or Strongyloides infection. It is
recommended that the results obtained be interpreted in conjunction with other diagnostic results and clinical information.
13. What to do if the results showed negative result, but the symptoms persist?
If the symptom persists, while the result is negative or non-reactive result, it is recommended to re-sample the patient few days later or use alternative testing method such as parasitological and serological methods.
AFTER RUNNING THE TEST
14. What should I do after running the test?
Handle all materials that come in contact with patient samples as infectious waste and dispose in a biohazard container.
GOOD LABORATORY PRACTICE
15. How is quality control ensured for the RESZON® Strongyloidiasis IgG4 Rapid Test?
Users should follow respective Good Laboratory Practice SOP of the labs. However, it is recommended to use external controls, positive and negative, to confirm the test procedure and to verify proper test performance, particularly under the following circumstances:
- New operator uses the kit, prior to performing testing of specimens.
- A new lot of test kits is used.
- A new shipment of test kits is used.
- The temperature used during storage of the kit falls outside of 2-30°C.
- The temperature of the test area falls outside of 15-30°C.
- To verify a higher-than-expected frequency of positive or negative results.
- To investigate the cause of repeated invalid results.