| CTRI Number |
CTRI/2025/01/079450 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
22/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Collection of Blood Samples to check the Performance of HIV, Hepatitis B, and Syphilis Test Kits |
Scientific Title of Study
Modification(s)
|
Protocol for the collection, storage and transportation of samples to evaluating laboratory (MHL & CIIMS ARC) and the conduct of the clinical and analytical performance evaluation of immunochromatographic assay - HIV 1 & 2 Antibody Test Kit, Hepatitis B Surface Antigen (HBsAg) Test Kit, Syphilis Antibody Test Kit. |
| Trial Acronym |
NIL |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| CPDL/HHS-01/IVDR-PR/075 Revision 1.1 dated 15 July 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjay Gaval |
| Designation |
Principal Investigator |
| Affiliation |
Ayush Blood Bank & Component Lab, Nagpur. |
| Address |
3rd floor, NRPL House, 22/1, Khare Marg, Dhantoli, Nagpur, Maharashtra 440012
Nagpur
MAHARASHTRA
440012
India |
| Phone |
9823638187 |
| Fax |
|
| Email |
sanjaygaval11.sg@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sharad Babasaheb Pangarkar |
| Designation |
Manager QA |
| Affiliation |
CUPID LIMITED |
| Address |
A-68, MIDC MALEGAON, Sinnar, Nashik, Maharashtra, India - 422113
Nashik
MAHARASHTRA
422113
India |
| Phone |
7722009580 |
| Fax |
|
| Email |
qa@cupidlimited.com |
|
Details of Contact Person
Public Query
|
| Name |
Sharad Babasaheb Pangarkar |
| Designation |
Manager QA |
| Affiliation |
CUPID LIMITED |
| Address |
A-68, MIDC MALEGAON, Sinnar, Nashik, Maharashtra, India - 422113
Nashik
MAHARASHTRA
422113
India |
| Phone |
7722009580 |
| Fax |
|
| Email |
qa@cupidlimited.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Cupid Limited |
| Address |
A-68, MIDC MALEGAON, Sinnar, Nashik, Maharashtra, India - 422113 |
| Type of Sponsor |
Other [Medical Device Manufacturing Company-indian] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Subramaniam Ravi Shankar |
Abhaya Hospital, Vijayawada |
Chalasani Venkata Krishaniah Street, Suryaraopet, Vijayawada, Andhra Pradesh 520002.
Krishna
ANDHRA PRADESH |
7794022370
drctresearch@gmail.com |
| Dr Vaibhav Kailash Chawale |
Arpan blood bank |
31, Ambazari Rd, Corporation Colony, Ambazari, Nagpur, Maharashtra 440010
Nagpur
MAHARASHTRA |
9561797383
chawalevaibhav007@gmail.com |
| Dr Sanjay Gaval |
Ayush Blood Bank & Component Lab, Nagpur |
3rd floor, NRPL House, 22/1, Khare Marg, Dhantoli, Nagpur, Maharashtra 440012
Nagpur
MAHARASHTRA |
9823638187
sanjaygaval11.sg@gmail.com |
| Dr Shailendra G Mundhada |
Dhruv Pathology and Molecular Diagnostic Lab Nagpur |
Laxmi Nagar, Nagpur, Maharashtra 440022, India.
Nagpur
MAHARASHTRA |
9822572421
shailendramundhada@gmail.com |
| Dr Mahadeo Mane |
Dr. D. Y. Patil Hospitla and MRC Kolhapur |
Dr. D.Y.Patil Hospital
and MRC, Kadamwadi, Kolhapur , City & postal code: 416003, State & Country: Maharashtra,
India
Kolhapur
MAHARASHTRA |
8411826769
manepath@yahoo.com |
| Dr Manikanta Veesam |
Nuha Hospitals, Guntur |
12-19-61&62, Old Bank St, Kothapeta, Guntur, Andhra Pradesh 522001
Guntur
ANDHRA PRADESH |
9603725835
manikantaveesam@gmail.com |
| Dr Ketan Kshirsagar |
Sangvi multispeciality Hospital Pvt Ltd |
Sr. No. 71/1/1/189 City survey no 2387, krushna chowk, Pune, 411027
Pune
MAHARASHTRA |
8805204575
dehuhospital2@gmail.com |
| Dr Nandini Moghe |
Swami Vivekanand Medical Mission, Nagpur |
Swami Vivekanand Medical Mission, Parsodi, Khapri, Khapri, Nagpur, Maharashtra 441108
Nagpur
MAHARASHTRA |
7767827837
drnandinij@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| independent Ethics Committee Fusion Clinical Research |
Approved |
| Institutional Ethics committee |
Approved |
| Institutional Ethics committee of Nuha Hospital |
Approved |
| Institutional Ethics Committee of Sangvi Multispeciality Hospital |
Approved |
| Jasleen Hospital Ethics Committee |
Approved |
| Jasleen Hospital Ethics Committee |
Approved |
| Jasleen Hospital Ethics Committee |
Approved |
| Jasleen Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B20||Human immunodeficiency virus [HIV]disease, (2) ICD-10 Condition: B169||Acute hepatitis B without delta-agent and without hepatic coma, (3) ICD-10 Condition: A530||Latent syphilis, unspecified as early or late, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
HBsAg Rapid Test Cassette |
HANGZHOU ALLTEST BIOTECH CO. LTD, The HBsAg Rapid Test Cassette is a rapid chromatographic
immunoassay for the qualitative detection of Hepatitis B Surface Antigen in
human whole blood, serum or plasma to aid in the diagnosis of HBsAg infection.
|
| Comparator Agent |
MERISCREEN HIV 1-2 WB
|
MERISCREEN HIV 1-2 WB Test is a single-use,
qualitative, screening, in-vitro diagnostic immunochromatography assay
and used for the detection of antibodies (IgG, IgA, and IgM) specific to HIV1 and HIV-2 in human fingerstick whole blood, venous whole blood, serum,
or plasma specimens. |
| Comparator Agent |
ONE STEP SYPHILIS RAPID TEST |
ACCUCARE® ONE STEP SYPHILIS TEST is a modified
TPHA, Which qualitatively detects the presence of IgM and IgG class of
Treponema specific antibodies of syphilis in Whole Blood/Serum/Plasma
specimens within 15 minutes.
|
|
Inclusion Criteria
Modification(s)
|
| Age From |
13.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
HIV-1 Positive Subjects: Confirmed diagnosis of HIV-1
infection, including 40 non-B-subtypes all available HIV/1 subtypes shall be represented by at least 3 specimens per subtype.
HIV-2 Positive Subjects: Confirmed diagnosis of HIV-2
infection, including 40 non-B-subtypes
HBsAg Positive Subjects: Confirmed diagnosis of
Hepatitis B infection, including evaluation of different HBV markers such as genotypes, subtypes, or mutants.
Syphilis Positive subjects: Confirmed diagnosis of Syphilis infection, across different stages if available, including high and low positive specimens identified by at least two different serological tests (one of which is an enzyme immunoassay) for antibodies to T. pallidum.
Pregnant Women: Confirmed pregnancy.
Rheumatoid Factor & Other cross-reacting agents: Confirmed diagnosis of Rheumatoid Factor and, related infections
Hospitalized Subjects: Currently hospitalized for any condition.
Unselected Blood Donors: Individuals who have donated blood (Including first time donors). |
|
| ExclusionCriteria |
| Details |
General Exclusions:
Inability or unwillingness to provide informed consent.
Specific Exclusions:
For HIV-1 and HIV-2 Positive subjects: Co-infection with other significant infectious diseases (e.g., Hepatitis B or C).
For HBsAg Positive subjects: Co-morbid conditions with other chronic viral infections (e.g., HIV).
For Syphilis Positive subjects: Co-morbid conditions with other severe chronic conditions (e.g., severe cardiac, renal, hepatic issues).
For Pregnant Women: High-risk pregnancy conditions that may interfere with study participation.
For Rheumatoid Factor and Other cross-reacting agents: Concurrent participation in another clinical study that may interfere with study outcomes.
For Hospitalized Subjects: Conditions that may compromise the safety of the participant or the integrity of the study data.
For Unselected Blood Donors: Recent history of blood transfusion or donation within the last 3 months.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Analytical sensitivity
Analytical specificity and cross-reactivity
Diagnostic sensitivity and Positive predictive value
Diagnostic specificity and Negative predictive value
Hook effect
Precision (repeatability and reproducibility)
Validation of reading time |
At Baseline Visit (Single Visit) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NA (There is no impact on patients) |
NA |
|
|
Target Sample Size
|
Total Sample Size="7324"
Sample Size from India="7001"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
04/02/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study will include participants from various categories and clinical conditions, ensuring that the IVD test is evaluated across a broad spectrum of cases. This will include subjects with confirmed positive results for HIV-1, HIV-2, HBsAg and Syphilis. Additionally, the study will involve negative samples from pregnant women, subjects with autoimmune diseases such as rheumatoid factor or systemic lupus erythematosus, and those with other cross-reacting agents. Hospitalized subjects and unselected blood donors, including first-time donors, will also be included. Participants will be screened by healthcare professionals to ensure they meet the study’s inclusion and exclusion criteria for their respective disease group (HIV, HBsAg, or Syphilis). Eligibility will be determined based on relevant risk factors or clinical indicators, and informed consent will be obtained before participation. Upon enrollment, trained phlebotomists will collect blood samples from each participant following standard venipuncture procedures. The blood samples will be collected using EDTA, citrate, or heparin tubes for plasma separation, ensuring the prevention of clotting, and plain tubes for serum collection. Each specimen will be clearly labeled with a unique patient identification code, along with the date of collection, to ensure proper traceability throughout the study. Once collected, the blood samples will be transported to a MHL laboratory under strict temperature-controlled conditions. The MHL laboratory will be equipped with necessary resources to maintain the appropriate storage and processing environment, ensuring that the samples remain viable for testing. Upon arrival, the samples will be logged into the laboratory management system, where the unique identification numbers will be used to track the specimens throughout the testing process. In the MHL Laboratory the validation process will be initiated. |