Carestart Accessbio Antigen

The CareStart COVID-19 Antigen Test is a lateral flow immunochromatographic assay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal or anterior nasal swab specimens directly collected from individuals who are either suspected of COVID-19 by their healthcare provider within the first five days of symptom onset or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests.

Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet the requirements to perform moderate, high, or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., inpatient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

Lateral flow assay
Detect SARS-CoV-2 nucleocapsid protein antigen
Rapid results within 10-15 minutes
Intended at POC setting (i.e., in patient care settings) by medical professionals operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation
For use under the Emergency Use Authorization (EUA) only
For in vitro diagnostic use only
For prescription use only
For use with direct anterior nasal and nasopharyngeal swab specimens
Clinical Performance

93.75% PPAa and 99.32% NPAb when used with nasopharyngeal swab

87.18% PPAa and 100% NPAb when used with anterior nasal swab

CareStart Covid-19 Antigen Test Kits-Rapid Test Kits
Worldwide Shipping

Lateral flow assay
Detect SARS-CoV-2 nucleocapsid protein antigen
Rapid results within 10-15 minutes
Intended at POC setting (i.e., inpatient care settings) by medical professionals operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation
For use under the Emergency Use Authorization (EUA) only
For in vitro diagnostic use only
For prescription use only
For use with direct anterior nasal and nasopharyngeal swab specimens


Clinical Performance

93.75% PPAa and 99.32% NPAb when used with a nasopharyngeal swab
87.18% PPAa and 100% NPAb when used with anterior nasal swab

aPPA: Positive Percent Agreement, bNPA: Negative Percent Agreement.

CareStarfTM COVID-19 ANTIGEN RAPID TESTS
Why CareStartTM
COVID-19 Live infection 10 minutes Diagnostic Tests dose not require a machine reader! Abbott, Quidel, and BD require readers, that are in short supply.

â?¢ EASY TO USE
CareStart
â?¢ AVAILABILE Rapid Tests on the shelf available products (in inventory) with
We offer CareStartTM
reliable production and delivery schedules. Abbott, Quidel and BD testing cassettes are
in short supply with unreliable availability.
â?¢ FDA EUA
is currently the only Point-Of-Care rapid antigen test registered authorized under the FDA EUA.
CareStart
TM

CareStarfTM COVID-19 ANTIGEN RAPID TESTS Features
Identify individual's current infection status to COVID-19 Fast and easy to use in Point-of-Care setting
Qualitatively detect the SARS-CoV-2 nucleocapsid protein Use nasopharyngeal (NP) swab specimens
Reliable results only in 1O minutes
No special equipment or training required All-in-one package including collection swabs
High sensitivity (88.4�°/o) and specificity (100�°/o) Kit Components
20 test devices
20 extraction vials and caps
20 NP swabs
1 positive and 1 negative controls Package insert
Quick reference Instructions (QRI)

Lateral flow assay
No equipment required
Rapid results within 10 minutes
Minimally invasive specimen collection (nasopharyngeal swabs)
POC setting (i.e. in patient care settings) by medical professionals
Detects SARS-CoV-2 nucleocapsid protein antigen with ultra high performance
Identify acute infection wit 88.4% sensitive and 100% specificity

20 test/box
20 test devices
20 assay buffer
20 extraction vials and caps
20 specifimen collection swabs
1 positive and 1 negative control swabs
1 instructions for use

Access Bio
Covid 19
Antigen Test Kit
Care Start

The CareStart COVID-19 Antigen Test is a lateral flow immunochromatographic assay for the detection of extracted nucleocapsid protein antigens specific to SARS-CoV-2 in swab specimens directly collected from symptomatic individuals who are suspected of COVID-19 by their healthcare providers.

Access Bio CareStart rapid antigen POC test kits - We are now shipping (within the US) by the pallet at as low as $10.00 per test. 20 pcs per kit/box, 640 boxes per pallet.

The CareStart COVID-19 Antigen test kit allows for the rapid screening of COVID-19 infection on a large scale, with results in just 10 minutes. The CareStart COVID-19 Antigen Test is a lateral flow immunochromatographic assay for the detection of extracted nucleocapsid protein antigens specific to SARS-CoV-2 in swab specimens directly collected from individuals who are suspected of COVID-19 by their healthcare providers. This product is CLIA waived under FDA/EUA authorization.

Quantity: 8 Million test kits
MOQ: 1 Million
FOB: New Jersey USA
Price: 11.75 USD

Manufacturer: Access Bio

Seller: Access Bio Approved Distributor


Product: CareStart COVID-19 Antigen Home (OTC) Test Kit

Specifications: The FDA has issued the Emergency Use Authorization (EUA) for the CareStart COVID-19 Antigen Home (OTC) Test Kit.
2 Tests per kit/ 232 kits per carton


Availability: Available on October 5th

Quantity: Large Quantity

Minimum Order: 50,000 Kits

Maximum Order: 500,000 Kits (Larger orders on exception basis)



Pricing: 50,000 - 499,999 kits: $17.00 per kit
500,000+ kits: $16.00 per kit


Commission: Pricing does not include commission
Commission split 50/50 sell side and buy side
Minimum add-on of $1.00 (Exceptions on larger orders)
90% of buy side open starting with referral partner





SOP:

After NCNDA , distributor will get on a conference call.


1.NCNDA

2. PO and IMFPA Input Templates

Instructions on how too make out documents distributed after NCNDA


3. Invoice


4. Payment


5. Delivery