Export Snapshot

Minimum order

1000 Numbers

HSN Code

901890

Origin

India

Lead time

On request

Port of dispatch

On request

Packaging

Individually sealed test cassettes in a kit format

Shelf life / storage

As per product specification

Export markets served

AO BW LR NP ZM

Ability to customise

As per OEM brief

Values shown are for Labgene Bio-Tech Private Limited.

MDR 2017 and ISO13485:2016

Company Labgene Bio-Tech Private Limited

Labgene Bio-Tech Private Limited

Labgene Biotech is a leading Indian manufacturer at the forefront of IVD product development. We operate an ISO 13485-certified, WHO-GMP, and USFDA-compliant facility, with all processes driven by hundreds of validated SOPs. Our R&D team has developed over 200 diagnostic tests, with 30+ currently in active use across chain laboratories, government platforms (GEM Portal), private distributors, and international export markets.

Registered address: Mahesana, India. Industry: Healthcare, Medical Supplies & Pharmaceuticals › Biotechnology.

FIEO Registered

View profile →

Established

2019

Employees

51–100

GST

24AADCL8897L1ZQ

IEC code

AADCL8897L

Export markets

AO BW LR NP ZM

Member since

Jul 2025

Turnover

$2 MM - $5 MM

Incorporation type

On request

MDR 2017 and ISO13485:2016

Product details

The Labgene Syphilis Ab Rapid Test Kit detects both IgM and IgG antibodies to Treponema pallidum using recombinant antigens (Tp15, Tp17, Tp47). With 98–100% sensitivity and specificity validated by the National Institute of Biologicals (India), the kit ensures high reliability. It includes a built-in control line for procedural accuracy, requires no special equipment, and remains stable between 2°C to 30°C. Designed for professional use, the kit is suitable for hospitals, STI clinics, mobile health units, blood banks, and mass screening programs.

Description provided by Labgene Bio-Tech Private Limited.

Lateral flow immunoassay

Whole blood, serum, plasma

IgM and IgG antibodies to Treponema pallidum

Recombinant Tp15, Tp17, Tp47

Within 20 minutes

98% - 100% validated by National Institute of Biologicals, India

Procedural control line included

2°C to 30°C

No special equipment required

Professional use in hospitals, clinics, STI centers, blood banks, mobile units, mass screening

Specifications

Format

Rapid test cassette

Assay Method

Qualitative

Detection Method

Immunochromatographic lateral flow

Test Duration

20 minutes

Sample Volume

Recommended volume varies by sample type (whole blood/serum/plasma)

Shelf Life

Typically 12-24 months, depending on batch

Storage Conditions

Store between 2°C and 30°C

Certifications

Validated by National Institute of Biologicals (India)

Packaging

Individually sealed test cassettes in a kit format

Usage Restrictions

For professional in vitro diagnostic use only

Use cases

Category

Medical Diagnostic Equipment > Rapid Test Kits > Syphilis Rapid Test Kits

Primary application

Brand

labgene

Product type

Product

Logistics & handling

Lead time

On request

Packaging

Individually sealed test cassettes in a kit format

Storage condition

As recommended by supplier

Origin

India

Form

As listed by supplier

Commercials Labgene Bio-Tech Private Limited

Minimum order

1000 Numbers

Lead time

On request

Payment terms

As per negotiated commercial agreement

Frequently asked by buyers

Does the Labgene Syphilis Ab Rapid Test Kit differentiate between IgM and IgG antibodies?

No, the test qualitatively detects both IgM and IgG antibodies concurrently without differentiation to assess overall presence of antibodies to Treponema pallidum.

What sample types are compatible with this test kit?

This kit is compatible with human whole blood, serum, and plasma samples, providing flexibility for different clinical settings and sample availability.

Is any special laboratory equipment required to perform the test?

No specialized instrumentation or equipment is needed; results are visually interpreted on the lateral flow cassette after 20 minutes.

Can this test be used under field conditions or in mobile health units?

Yes, the test’s stability at 2°C to 30°C and lack of equipment needs make it suitable for use in field settings and mobile healthcare environments.

How reliable is the Labgene Syphilis Ab Rapid Test Kit in detecting early-stage syphilis?

The kit detects antibodies across all stages of syphilis infection with a validated sensitivity and specificity of 98-100%, supporting reliable early diagnosis.

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