ST Polson

📌 Product Name:

Influenza A+B & COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold)

🖼️ Product Image:

(Use the product image from the brochure — show the box, test device, swab, extraction tube, and collection bag together on a clean white background.)

✅ Product Overview:

The DeepBlue Influenza A+B & COVID-19 (SARS-CoV-2) Antigen Test Kit is a rapid, self-testing diagnostic tool for qualitative and differential detection of the nucleocapsid protein antigen of Influenza A, Influenza B, and SARS-CoV-2 from human nasal swab specimens.

  • Format: Lateral flow colloidal gold immunoassay
  • Easy at-home operation
  • Results in 15 minutes

📋 Key Features:

  • ✔️ Detects 3 infections in 1 test
  • ✔️ High accuracy:
    • COVID-19: Sensitivity 96.8%, Specificity 100%
    • Influenza A+B: Sensitivity >99%, Specificity >99%
  • ✔️ Simple nasal swab collection
  • ✔️ CE certified, ISO 9001:2015 quality

📦 Kit Contents:

Each box includes:

  • ✅ 1 x Test device
  • ✅ 1 x Sterile nasal swab
  • ✅ 1 x Antigen extraction tube with reagent
  • ✅ 1 x Collection bag
  • ✅ 1 x Instructions for Use (IFU)

📏 Available Packaging:

Quantity

Box Size

Carton Qty

Carton Size

1 pc/box

130×60×19 mm

500 pcs

54×49.5×32.5 cm

5 pcs/box

130×70×55 mm

160 boxes (800 tests)

54×46×40 cm

25 pcs/box

260×120×70 mm

50 boxes (1250 tests)

62×54×38 cm

⚙️ Specifications:

Item

Details

Test Type

Colloidal gold immunochromatography

Sample Type

Nasal swab

Detection Time

15 minutes

Storage

2–30°C

Shelf Life

24 months

Certification

CE, ISO 9001:2015

🔬 How to Use:

1️⃣ Blow your nose, wash hands, and unpack the swab.
2️⃣ Insert swab 2 cm into nostril, rotate 5 times; repeat in other nostril.
3️⃣ Place swab into extraction tube, rotate 10 seconds, press against tube wall 3 times.
4️⃣ Attach nozzle cap and add 2 drops to the test cassette’s specimen well.
5️⃣ Wait 15 minutes and read the result.

🧾 Result Interpretation:

  • COVID-19 Positive: Both control line C and test line T appear.
  • Flu A/B Positive: Control line C plus test lines A and/or B appear.
  • Negative: Only control line C appears.
  • ⚠️ Invalid: If no C line appears, repeat the test.

⚠️ Warnings & Precautions:

  • For in vitro diagnostic use only
  • For self-testing; children under 15 should test under adult supervision
  • Store properly; do not freeze
  • Dispose of all used materials in the provided collection bag
  • Follow instructions carefully for accurate results

🧪 Performance & Compliance:

  • Limit of Detection:
    • COVID-19: 80 TCID50/ml
    • Influenza A/B: 100–25,800 TCID50/ml (depending on strain)
  • Cross-reactivity: None with other common viruses like RSV, adenovirus, rhinovirus.
  • Quality Management: ISO 9001:2015 certified.