What types of diagnostic products does Astam Diagnostics manufacture?

Astam Diagnostics manufactures a wide range of In-Vitro Diagnostic (IVD) kits and medical devices, including Biochemistry Reagents, Rapid Diagnostic Test Kits (Immunochromatography), Immunology kits, and advanced laboratory consumables for hospitals and diagnostic centers.

Does Astam Diagnostics provide OEM and private label manufacturing services?

Yes. Astam Diagnostics offers end-to-end OEM and private label manufacturing services for IVD kits and medical devices, custom-tailored to the formulations, packaging, branding, and regulatory compliance standards of global healthcare brands.

What regulatory and quality certifications does your manufacturing facility hold?

The manufacturing plant operates under stringent international quality protocols. Astam Diagnostics is ISO 13485:2016 certified, with products manufactured in compliance with CDSCO regulations and CE certification standards.

How can global distributors or laboratories request a bulk supply or custom quote?

For wholesale distribution, laboratory tenders, or bulk supply requirements, interested parties can fill out the corporate enquiry form on the website at https://www.astamdiagno.com/contact-us/ or email the B2B procurement cell directly. The company provides scalable logistics for both domestic (Pan-India) and international shipments.

Do you ensure batch-to-batch consistency for your biochemistry reagents and rapid kits?

Yes. The in-house R&D facility and quality assurance teams perform rigorous analytical and clinical evaluations on every batch, guaranteeing exceptional sensitivity, specificity, and long-term stability across all diagnostic products.

Where can individuals or small clinics buy retail quantities of your products online?

While the main website handles bulk corporate contracts, a dedicated e-commerce storefront is available for retail orders. Small clinics, laboratories, and individual clients can purchase selected medical devices at https://shop.astamdiagno.com.

HIV Ag-Ab TEST (4th GEN)

Home > Product > HIV Ag Ab TEST (4th GEN)

The 4th Generation HIV Ag/Ab rapid test kit is a professional-use, highly sensitive qualitative immunochromatographic assay. It is engineered for the simultaneous and differential detection of the HIV-1 p24 antigen alongside antibodies (IgG, IgM, IgA) to both HIV-1 and HIV-2 in human clinical specimens. This dual-action approach significantly reduces the diagnostic window period for early detection.

HIV Ag-Ab TEST (4th GEN)

Product Characteristic	Specification & Details
Product Name	Pratham HIV Ag/Ab 4th Gen Test Kit
Test Generation	4th Generation (Combination Antigen & Antibody Assay)
Target Detected	Free HIV-1 p24 Antigen & HIV-1/HIV-2 Antibodies
Diagnostic Performance	~99% Sensitivity and ~99% Specificity
Sample Type Compatibility	Whole Blood / Serum / Plasma
Result Read Time	15–20 minutes
Intended Usage	Blood Banks, Diagnostic Laboratories, and Clinical Screening

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Key Product Features

Reduced Window Period: Detects the early p24 viral antigen before the body produces antibodies, allowing early detection weeks ahead of 3rd-gen tests.
Dual Target Mechanism: Combines solid-phase antibody and antigen recognition to capture multiple viral markers in a single workflow.
Rapid Processing Turnaround: Provides clear, visual bands within 15–20 minutes, allowing healthcare providers to make quick screening decisions.
Universal Sample Processing: Fully validated to perform accurately with fingerprick/venipuncture whole blood, serum, or plasma.

Frequently Asked Questions

Q1. What is the main clinical advantage of a 4th-generation HIV test kit?

Ans: The 4th Gen HIV test kit detects both HIV-1/HIV-2 antibodies and the free HIV-1 p24 antigen. Traditional 3rd-gen tests only look for antibodies, which take weeks to develop. By targeting the p24 antigen (a protein that appears early after exposure), this kit drastically shortens the diagnostic window period.

Q2. What is the accuracy of the Astam 4th Gen HIV rapid diagnostic kit?

Ans: The Astam Pratham 4th Gen HIV kit delivers exceptional diagnostic reliability with evaluated parameters of ~99% clinical sensitivity and ~99% specificity, ensuring minimised risk of false results in screening environments.

Q3. How long should you wait before reading the results of this rapid kit?

Ans: The visual test strips develop definitive results between 15 to 20 minutes after the addition of the clinical specimen and sample buffer. Results interpreted beyond the 20-minute mark should be treated as invalid.

Why Choose Astam Diagnostics?

Certified Manufacturing Facility: Crafted inside a state-of-the-art manufacturing infrastructure compliant with strict quality controls.
B2B Bulk Fulfillment: Large-scale commercial capacity to supply major hospital chains, independent labs, and international distribution agents.
Global Standard Export: Ready inventories systematically engineered to fulfil regulatory criteria for PAN India logistics and cross-border trade.

Bulk Supply & Wholesale Distribution

We cater to institutional distribution, bulk private laboratory orders, and government healthcare supply contracts. Contact our commercial sales wing to request wholesale tier matrices or technical instruction booklets.