Sars cov 2 Antigen Rapid Test Kit

Effectivity Traits

JOYSBIO’s coronavirus Ag check out gear was independently evaluated at Centro Diagnostico Delta S.r.l. in Italy between October 2020 and January 2021. An entire of 107 constructive specimens had been examined with JOYSBIO’s COVID-19 Antigen Speedy Verify Tools. These specimens had been collected from victims who’re suspected of COVID-19 with nasal swabs. The coronavirus antigen check out gear’s sensitivity and specificity are in distinction in the direction of a CE-IVD marked RT-PCR check out gear. This medical evaluation is carried out beneath the concept SARS-CoV just isn’t spreading domestically. 

Primarily based on the medical analysis of 492 samples, the detection sensitivity is 98.13%, and the specificity is 99.22%.

• Constructive % Settlement (PPA) = 105/107 (98.13%) (95%CI: 93.4%~99.8%)
• Adversarial % Settlement (NPA) = 382/385 (99.22%) (95%CI:97.7%~99.8%)
• Accuracy = (105+382)/492×100%=98.98%
• Kappa = 2×(105×382-3×2)/(108×385+107 ×384) = 0.97＞0.5

The limit of detection (LOD) of this product is 1.6 x 10² TCID₅₀/mL, calculated by way of a gradient dilution methodology.

Please Observe:

 Beneath listed kits are validated with the talked about batch amount solely. Responsibility for batch to batch consistency would not lies with ICMR.
 Minimal acceptance requirements of sensitivity and specificity of Speedy Ag Verify Kits:
 Validated as a Stage of Care Verify (POCT) with out transport to a laboratory setupSensitivity: 50% and above; Specificity: 95% and above
 Validated in a laboratory setup with samples collected in Viral Transport Medium (VTM)- Sensitivity: 70% and above; Specificity: 99% and above
 Antigen based totally speedy assessments which might be US-FDA permitted will be utilized instantly after due promoting and advertising approval from DCGI.

In June 2020, JOYSBIO Biotechnology proudly launched a model new COVID-19 Antigen Speedy Verify Tools (Colloidal Gold). The model new coronavirus antigen check out gear is a lateral transfer immunoassay for the qualitative detection of SARS-COV-2 antigen (nucleocapsid protein) in larger respiratory samples with nasal swabs or saliva in the midst of the acute part of an an infection. An uncut sheet format is on the market.

Choices

• 15-minute speedy detection
• Simple-to-operate coronavirus antigen check out
• A lot less-invasive nasal (NS) swab sample assortment
• CE-IVD marked
• Accessible in half/5/20 assessments/subject.

Abstract

Background

The Coronavirus sickness 2019 (COVID-19) pandemic continues to unfold internationally. Due to this fact, there’s an urgent need for fast, straightforward, and proper assessments to diagnose excessive acute respiratory syndrome coronavirus 2 (SARS-CoV-2) an an infection. Effectivity traits of the speedy SARS-CoV-2 antigen detection check out must be evaluated and in distinction with the gold customary real-time reverse transcription-polymerase chain response (RT-PCR) check out for prognosis of COVID-19 situations.

Methods

The speedy SARS-CoV-2 antigen detection check out, Customary Q COVID-19 Ag gear (SD Biosensor®, Republic of Korea), was in distinction with the real-time RT-PCR check out, Allplex 2019-nCoV Assay (Seegene®, Korea) for detection of SARS-CoV-2 in respiratory specimens. Four hundred fifty-four respiratory samples (primarily nasopharyngeal and throat swabs) had been obtained from COVID-19 suspected situations and converse to folks, along with pre-operative victims at Siriraj Hospital, Bangkok, Thailand all through March–Would possibly 2020.

Outcomes

Of 454 respiratory samples, 60 (13.2%) had been constructive, and 394 (86.8%) had been detrimental for SARS-CoV-2 RNA by real-time RT-PCR assay. The size from onset to laboratory check out in COVID-19 suspected situations and converse to folks ranged from Zero to 14 days with a median of three days. The speedy SARS-CoV-2 antigen detection check out’s sensitivity and specificity had been 98.33% (95% CI, 91.06–99.96%) and 98.73% (95% CI, 97.06–99.59%), respectively. One false detrimental check out consequence was from a sample with a extreme real-time RT-PCR cycle threshold (Ct), whereas 5 false constructive check out outcomes had been from specimens of pre-operative victims.

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