Find Verified Diagnostic Kits Suppliers, Manufacturers and Wholesalers

Due to contractual obligations to the federal government, Current suppliers have increased costs and limited production of all point of care tests without notice. We have great news! To shield our customers from excessive price increases as well as provide immediate availability, we have secured multiple FDA EUA rapid antigen test kit options. These tests have similar and/or better accuracy along with individual buffer bottles. We are currently able to provide three options: Clarity-Sienna, Indicaid and Celltrion DiaTrust kits. We work directly with the distributor and can supply by the pallet or case with pricing as low as $6.00 per kit.

CLIA Waived

Use of this test with all authorized specimen types is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements to perform moderate or high complexity tests.

This test is also authorized for use with fingerstick whole blood specimens only at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

The CLIA Waived COVID-19 IgG/IgM Rapid Test Device is an in vitro immunoassay for the direct and qualitative detection of anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG in human whole blood, serum, or plasma. The test is for professional use only.

Indication:

Qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood (sodium EDTA), serum, or plasma (sodium EDTA). Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories.

About Test Device

EUA Authorized
CE Mark
Test does NOT give positive or negative result for COVID-19 virus. This is an antibody test, it only indicates past or recent infection.
Read Results in 15 Minutes
9 Month Expiration from Date of Manufacture
Contents

20 Test Devices
20 Disposable Pipettes
20 Alcohol Prep Pads
Sterile Safety Lancets
Buffer
Package Insert

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

Master Carton - Contains 625 Tests

For International Sale Only - Call for Pricing

The COVID-19 IgG/IgM Rapid Test Device is an in vitro Immunoassay for the direct and qualitative detection of anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG in human whole blood, serum, or plasma. The test is for professional use only.

Indication:

Qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood (sodium EDTA), serum, or plasma (sodium EDTA). Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.

About Test Device

Gives Positive or Negative Result for COVID-19 IgM/IgG antibodies
Read Results in 15 Minutes
Contents of each box

25 Test Devices
25 Disposable Pipettes
25 Alcohol Prep Pads
Sterile Safety Lancets
Buffer
Package Insert

STANDARD M nCoV Real-Time Detection kit is used for rapid identification and detection of novel coronavirus (2019-nCoV) nucleic acids in human nasopharyngeal swabs and throat swab samples.
- One tube reaction for identification and detection of 2019-nCoV
- One-step Real-Time RT-PCR
- Provide all reagents required for PCR
- Designed according to WHO interim guidance for laboratory testing for 2019 novel coronavirus (2019-nCoV) in humans"
- nCoV primers/probes ORF1ab (RdRp) gene, E gene
Provide Internal controls


Kindly check ghope-ppe.com. All information is for a consumer. If you want to buy a bulk, please contact us.

PPE COVID home test kit supply to worldwide.
Shipping: CIF
Payment: L/C
MOQ: 100,000pcs