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COVID-19 (SARS-CoV-2) Antigen Test Kit -Saliva (Self-Testing) Question about the product

COVID-19 (SARS-CoV-2) Antigen Test Kit -Saliva (Self-Testing)
Quantity Price
from 1
€0.20
€0.24 incl. 19% VAT
(€0.20 per item, €0.24 incl. 19% VAT per item)
from 1000
€0.15
€0.18 incl. 19% VAT
(€0.15 per item, €0.18 incl. 19% VAT per item)
Sales and shipping through:
HCP Health Care Plus GmbH
Company headquarters: Germany
Member since: < 1 year
from €0.15
€0.18 incl. 19% VAT
Please login to add something to your cart.
Minimum order quantity:
1
Increment to order:
1
Processing time:
1 days

Basic informations

DAN 4DS0HNAZ
GTIN 6952062769217
model dpll1
Packaging Unit 1 item
Manufacturer Anhui Deepblue Medical Technology Co., Ltd.
Brand Deepblue
Processing time 1 days
Return policy This article cannot be returned
Country of origin China
Country of Manufacture China
This article has an expiration date.

Article description

  • Product Detail

Intended use


This product is used for in vitro qualitative detection of the SARS-CoV-2 antigen in human saliva specimen. This product is intended for home self-testing as a rapid test for novel coronavirus infection. Both symptomatic and asymptomatic infections can be tested.



Test principle


This product uses the double antibody sandwich method to detect the SARS-CoV-2 N protein. When the sample contains the coronavirus antigen, both the test line (C) and the control line (T) will appear, and the result will be positive. When the sample does not contain the coronavirus antigen or no coronavirus antigen is detected, the test line (T) will not appear, only control line (C) will appear.



Product advances


1.Pre-filled buffer solution, easier operation. 
2.Passed the PEI evaluation. 
3.Room temperature storage.
4.No need instrument, get results within 15 minutes.
5.Identify acute or early infection.
6.No reduction in sensitivity test against the Alpha, Beta, Delta, Gamma, Lambda, Omicron variant and so on. 



Materials and Components


1.Test Device

2.Instruction

3.Antigen Extraction Tube with Extraction Reagent

4.Collection Bag

5.Sterilized Swab



Product Information


Specification1pcs/box,5pcs/box,25pcs/boxSpecimenHuman SalivaStorage4-30℃



Test Procedure


Allow test device extraction reagent and specimens to equilibrate to room temperature(15 ~ 30 ℃) prior to testing.Please keep the temperature at 15 ~ 30 ℃ and the humidity at20%-80% during the whole test.


1.Specimen Collection

(1)Remove the sterilized swab from the packaging.

(2)Insert the soft tip of sterilized swab into the mouth, actively swab inside of the mouth and tongue to collect saliva forapproximately 30-60s until the soft tip

is filled with saliva.

2.Testing


3.Test Results

Read result at 15 minutes.Do not read results after 30 minutes. 





Clinical Performance


There were 600 cases overall in the study, including 150 positive samples and 450 negative samples. Statistics of nasal swab test results were as follows:


Reference RT-PCR Assay

95% Wilson Score CI

LCI

UCI

DEEPBLUE 

SARS-CoV-2

Ag Test

 

POS

NEG

Total

PPA

98.7%

92.33%

99.07%

POS

148

0

148

NPA

>99.9%

98.17%

100%

NEG

2

450

452

PPV

>99.9%

98.17%

100%

TOTAL

150

450

600

NPV

99.6%

92.76%

99.31%


Sensitivity: 98.7% (95% CI: 92.33% - 99.07%)Specificity: >99.9% (95% CI: 98.17% - 100%)


Payment options

  • invoice
  • Prepayment
  • PayPal

Shipping options

  • Free shipping from 100 €
  • Standard shipping from €8.00
Sales and shipping through:
HCP Health Care Plus GmbH
Company headquarters: Germany
Member since: < 1 year
from €0.15
€0.18 incl. 19% VAT
Please login to add something to your cart.
Minimum order quantity:
1
Increment to order:
1
Processing time:
1 days
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