SARS-CoV-2 Antigen Lateral Flow Test Kit (Individually Wrapped) 15 Minute Rapid Detection

£119.25

Equivalent to: £7.95 Each

Case of 15

Code

82288

In Stock

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Details

15-20 Minute Antigen Rapid Test Kit - SARS-CoV-2

Please note: Due to the nature of this product we cannot accept any returns.

Self-administrating, individually-wrapped test kit
Results in 15-20 minutes
Easy to operate coronavirus antigen test
Less invasive nasal (NS) swab sample collection
CE-IVD marked
Each case contains 15 x individually wrapped test kits
Test Kit includes: Test Device, Buffer Bottle, Extraction Tube & Nozzle Cap, Sterilised Nasal (NS) Swab

These Test Kits are individually wrapped and are to be given to the individual to self-administer the test & DO NOT require any intermediatory to handle any part of the testing process.

Each case contains 15 x individually wrapped test kits.

Carefully read the instructions supplied with each test kit.

The SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) is a lateral flow immunoassay for the qualitative detection of SARS-CoV-2 antigen (nucleocapsid protein) in upper respiratory samples with nasal swabs or saliva during the acute phase of infection.

COVID-19 Antigen Test Procedure

Twist off the cap of the buffer bottle, carefully dispense all buffer into the extraction tube.
After collecting upper respiratory sample with nasal swab, insert the swab into the extraction tube, plunge the swab up and down in the fluid for a minimum of 10 seconds. Hold the swab against the bottom of the tube, rotate three turns. DO NOT splash liquid out of tube.
Remove the swab while squeezing the sides of the tube to extract the liquid from the swab.
Press the nozzle cap firmly onto the extraction tube. Mix throughly by swirling or flicking the bottom of the tube.
Gently squeeze the tube's rigid body, dispense two (2) drops of the buffer-specimen mixture into the sample well on the coronavirus antigen test cassette.
Read the test results between 15 and 20 minutes. Do not read the results after 20 minutes.

Interpretation of Test Results

NEGATIVE: A coloured band appears on the contol line (C line); no coloured band shows up on the test line (T line). A negative result indicates there is no coronavirus antigen (N protein) in the specimen, or the level of coronavirus antigen below the detection limit.
POSITIVE: A coloured band appears on the control line (C line), a second coloured band shows up on the test line (T line). A positive result indicates the presence of COVID-19 antigen (N protein) in the patient sample.
INVALID: No coloured band appears on the control line (C line). An invalid test results suggests there might be insufficent buffer volume or incorrect operationg procedures. Carefully review the test procedure and test the same patient again with another coronavirus antigen rapid test cassette.

JOYSBIO COVID Test Result Interpretation

COVID-19 Antigen Rapid Test Principle

The coronavirus antigen rapid test kit is a lateral flow assay that qualitatively detects the presence of nucleocapsid (N) protein in upper respiratory samples (nasal swabs). This lateral flow assay is designed with the sandwich immunoassay format. When the specimen is added onto the sample pad of a test cassette, coronavirus N protein binds with colloidal gold-labeled SARS-CoV-2 N protein antibody to form an antibody-antigen (Ab-Ag) complex. The Ab-Ag complex is captured by SARS-CoV-2 N protein antibody (Rabbit monoclonal antibody) when migrating to the test line under capillary action. A red-colored band will appear on the test line, which indicates the specimen is COVID-19 nucleocapsid protein positive. No color band will appear on the test line if the specimen does not contain any coronavirus antigen (N protein), or the antigen level is below detection limit.

The conjugation pad also contains colloidal gold-labeled chicken IgY, which is captured by Goat anti-chicken IgY on the control line as procedural control. A colored band on the control line represents the proper liquid flow through the cassette; the absence of a colored band on the control line indicates insufficient sample or buffer volume.

JOYSBIO COVID Test Kit Principle

Performance Characteristics

JOYSBIO's coronavirus Ag test kit was independantly evaluated at the Centro Diagnostico Delta S.r.l. in Italy between October 2020 and January 2021. A total of 107 positive specimens were tested with JOYSBIO's COVID-19 Antigen Rapid Test Kit. These specimens were collected from patients who are suspected of COVID-19 with nasal swabs. The coronavirus antigen test kit's sensitivity and specificity are compared against a CE-IVD marked RT-PCR test kit. This clinical evaluation is conducted under the assumption that SARS-CoV is no longer spreading in the community.

According to the clinical analysis of 492 samples, the detection sensitivity is 98.13% and the specificity is 99.22%

Positive Percent Agreement (PPA) = 105/107 (98.13%) (95%CI: 93.4%~99.8%)
Negative Percent Agreement (NPA) = 382/385 (99.22%) (95%CI:97.7%~99.8%)
Accuracy = (105+382)/492x100%=98.98%
Kappa = 2x(105x382-3x2)/(108x385+107x384) = 0.97 > 0.5

The limit of detection (LOD) of this product is 1.6 x 10² TCID₅₀/mL, calculated through a gradient method.

JOYSBIO Covid Test Kit Evaluation Report

Production Capacity and Standards

As one of the largest lateral flow assay manufacturers in China, JOYSBIO Biotechnology currently produces over 3,000,000 test kits per day to help healthcare professionals all over the world to expand COVID-19 antigen test capacity. JOYSBIO is a ISO 13485 certified manufacturer, the following quality management systems are implemented to ensure the delivery of high-quality lateral flow rapid diagnostic test kits.

EN ISO 13485:2016
EN ISO 14971:2012
EN ISO 15223-1:2016
EN ISO 18113-1:2011
EN ISO 18113-2:2011
EN ISO 23640:2016
EN 13975:2003
EN 13612:2002

Warnings

A negative result can occur if the SARS-CoV-2 virus present in the specimen is below the sensitivity of the kit.
Not for the screening of donated blood.
Do not smoke, drink or eat in areas where specimens or kit reagents are being handled.
Dispose of all specimens and materials used to perform the test as biohazardous waste.
Handle the negative and positive controls in the same manner as patient specimens for operator protection.
Do not perform the test in a room with strong airflow, i.e an electric fan or strong air-conditioning.

Storage & Stability

Store at 2~30°C in the sealed pouch up to the expiration date and the vailidity is tentatively 24 months. Do Not Freeze.
The test cassette should be used within 1 hour after taking out from the aluminium foil bag.
Keep away from sunlight, moisture and heat.

This test is only provided for use by clinical laboratories or to healthcare workers for point-of-care testing, and not for at home testing.

More Information

More Information
Pack Size	EA
Selling Unit	CS15

Delivery & Returns

With our own dedicated fleet of vans servicing the North West and a dependable courier service for the rest of the country, we endeavour to get any stocked items ordered before 3pm to you within 48 hours (working days). Any UK mainland order placed over £50 (excluding VAT) is eligible for free delivery. For full information regarding our delivery details and routes, please click here.

If you'd prefer to collect your order from our Stockport store, simply select the 'Click & Collect' option at checkout, complete the order and we'll do the rest. Click & Collect is available for paid orders only. Please bring a copy of your Order Confirmation with you when you collect your order. We have plenty of FREE parking available and there are strict social distancing measures in place to protect our staff and customers.

If for some reason you are unsatisfied with your order, we offer a refund on all purchases of stocked goods if they are returned in the original box and in the condition they were sold, within 30 days. Charges may apply. For full information regarding returns, collection fees and charges relating to non-stock / special order items, please refer to our Returns Policy.

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