Description

The ECOTEST COVID-19 Antigen Saliva Test Kit offers a convenient and non-invasive method for detecting SARS-CoV-2 antigens using saliva samples. Manufactured by Guangdong Decheng Biotechnology Co., Ltd., this kit is designed for rapid self-testing, making it suitable for use in various settings such as homes, workplaces, and public events.

Key Features

• Non-Invasive Collection: Utilizes an oral saliva swab, eliminating the need for nasal swabs.
• Quick Results: Provides results within 10 to 15 minutes, with a simple two-step process.
• User-Friendly: Includes an instructional video accessible via a QR code on the packaging.

Intended Use

This test kit is suitable for individuals, including children aged 2-15 years (with adult assistance), particularly within the first seven days of symptom onset. It is designed for use across diverse environments such as healthcare, aged care, retail, hospitality, and more.

Test Method

The kit employs a lateral flow immunoassay technique, using anti-SARS-CoV-2 antibodies immobilized on a nitrocellulose membrane. The results are visually interpreted through color bands:

• Positive Result: Presence of a colored band in the test region.
• Valid Test: Presence of a band in the control region.

Kit Contents

Each kit contains:

• 2 or 5 saliva test pens/collectors
• Extraction buffer (if applicable)
• Instruction leaflet
• Waste disposal bags

A timer or stopwatch is required but not included.

Instructions for Use

1. Avoid eating, drinking, or smoking 30 minutes before testing.
2. Assemble the saliva collector as instructed.
3. Collect saliva by placing the mouthpiece under the tongue.
4. Insert the collector into the test cassette or buffer tube.
5. Wait for the specified time and read the result.
6. Dispose of materials using the provided waste bag.

Performance

• Sensitivity: 85.9%
• Specificity: 94.4%
• Overall Agreement: 91.2%

The kit effectively detects various COVID-19 variants, including Alpha, Beta, Gamma, Delta, and Omicron. It shows no cross-reactivity with common respiratory pathogens.

Precautions

• Ensure packaging integrity before use.
• Store between 2–30°C and do not freeze.
• Single-use only; handle as a potential biohazard.

Regulatory Status

The kit is registered with the Australian Register of Therapeutic Goods (ARTG 372335) and approved by the TGA for home use. It has a shelf life of 24 months, with expiration details provided on the packaging.

Physical Specifications

• Weight: 0.07 kg
• Dimensions: 20 × 5.5 × 3 cm

This test kit serves as a valuable tool for minimizing testing bottlenecks, providing timely results to help manage public health effectively.