parahealth diagnostics SARS-CoV-2 Antigen Rapid Test for Self-Testing Use (5 tests)

The parahealth diagnostics SARS-CoV-2 Antigen Rapid Test

delivers fast, reliable COVID-19 results in just 15 minutes — with a gentle anterior nasal swab you can perform comfortably at home. Clinically validated with an outstanding sensitivity of 99.13% and a specificity of >99.99% compared to RT-PCR, this CE-certified rapid antigen test (CE 1434) sets the standard for at-home SARS-CoV-2 detection. Trusted by pharmacies, healthcare providers and consumers across Europe.

Why Choose This COVID-19 Self-Test?

• Best-in-class accuracy: 99.13% sensitivity and >99.99% specificity — clinically validated against RT-PCR in a study of 575 patients. Zero false-positive results were recorded, providing the reliability you need for confident decision-making.
• Result in 15 minutes: Get your COVID-19 test result quickly — no laboratory, no appointment, no waiting. Perfect for pre-travel screening, workplace testing, or when symptoms appear.
• Gentle nasal swab: Easy anterior nasal swab (only 1.5 cm depth) — comfortable for self-testing at home. No deep nasopharyngeal swab required, making the test suitable for repeated use.
• CE-certified (CE 1434): Certified under EU Directive 98/79/EC by PCBC (Poland) — approved for sale and self-use in all EU member states. Meets the highest European standards for in-vitro diagnostics.
• Complete kit: 5 test cassettes, 5 sterile swabs, 5 extraction tubes with buffer solution, tube stand, and multilingual instructions — everything you need, ready to use out of the box.
• No cross-reactivity: Zero false-positive results from Influenza A/B, RSV, Adenovirus, Rhinovirus, Enterovirus, or more than 30 other respiratory pathogens. The only known cross-reaction is with SARS-CoV-1 (not in circulation).
• Variant-proof detection: Targets the conserved N-protein — no sensitivity loss against the D614G, Alpha (B.1.1.7), or Beta (501Y.V2) variants. Reliable detection regardless of emerging mutations.

Clinical Performance & Medical Data

The parahealth diagnostics COVID-19 rapid test was evaluated in a clinical study involving 575 symptomatic patients. Test results were compared against a commercialized RT-PCR molecular assay as the reference standard. The clinical data demonstrates exceptional performance:

• Sensitivity: 99.13% (114/115 positive samples correctly identified; 95% CI: 96.24–99.85%)
• Specificity: >99.99% (460/460 negative samples correctly identified; 95% CI: 99.02–99.97%)
• Overall accuracy: 99.83% — among the highest in the rapid antigen test category
• Limit of Detection (LoD): 75.5 TCID₅₀/mL using inactivated SARS-CoV-2 virus culture

The test is based on immunochromatographic technology. Each test cassette contains anti-SARS-CoV-2 antibodies on the detection line (T) and an IgG antibody on the quality control line (C). When the extracted sample flows through the membrane, any SARS-CoV-2 nucleoprotein antigens present will bind to the colored conjugate and form a visible line, indicating a positive result.

Who Should Use the parahealth COVID-19 Self-Test?

Whether you are a pharmacy stocking COVID-19 self-tests for retail, a clinic screening visitors, or an individual testing at home — the parahealth diagnostics test is designed for your needs. Approved for self-use by adults aged 16–69 years; children under 16 and adults over 69 can be tested under supervision. Individually sealed test cassettes, compact packaging, and a shelf life through December 2026 make it ideal for pharmacies, resellers, and bulk purchasers.

How to Perform the COVID-19 Rapid Test

Insert the swab approximately 1.5 cm into each nostril, rotate it five times, and then dip it into the extraction buffer solution. Squeeze the tube, apply 2 drops onto the test cassette, and read the result after 15 minutes. Two lines (C + T) = positive result. One line (C only) = negative result. A fully illustrated, step-by-step instruction leaflet is included with every kit in 9 languages (DE, EN, FR, ES, IT, PT, NL, PL, SV).

Package Contents

• 5x individually sealed test cassettes with desiccant
• 5x sterile anterior nasal swabs
• 5x extraction tubes pre-filled with buffer solution
• 1x tube stand
• 1x multilingual package insert (DE, EN, FR, ES, IT, PT, NL, PL, SV)

Storage & Shelf Life

Store the test kit in a dry place between 2-30 C. Keep away from light. Do not freeze. Do not use the test after the expiry date printed on the foil pouch and outer box. Current batch expiry: December 2026. The long shelf life makes this test ideal for stockpiling and emergency preparedness.

Regulatory Information

Manufactured by VivaChek Biotech (Hangzhou) Co., Ltd. for parahealth (Bormann Bioscience LLC). CE-marked under IVD Directive 98/79/EC. Notified Body: PCBC (CE 1434). Listed at the German Federal Institute for Drugs and Medical Devices (BfArM) as SARS-CoV-2 rapid antigen test for self-testing use. HSC Common List ID: 2758. PZN: 19230895.