95% Filtration
USA MADE
Reduces Exposure to blood and body fluids
Minimized contamination from inhaled microns
Latex free
Fiberglass free
Form fit design
3 Ply construction
BinaxNOW COVID-19 Ag Card
For Rapid Detection of SARS-CoV-2 | FDA EUA | IVD Use | RX Only
The BinaxNOW COVID-19 Ag Card is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs from individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset.
Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in anterior nasal (nares) swabs during the acute phase of infection.
Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status.
Negative results should be treated as presumptive, do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions.
The BinaxNOW COVID-19 Ag Card is intended for use by medical professionals or trained operators who are proficient in performing rapid lateral flow tests. BinaxNOW COVID-19 Ag Card is only for use under the Food and Drug Administration's EUA.
Kit Details
Test Card: 40 cards with test strips
Extraction Reagent: bottle containing 7.5 mL of extraction reagent
Nasal swabs: 40 sterile, single use specimen sampling swabs
Positive Control Swab: 1 each â??individually wrapped for single use
Negative Control Swab: 1 each â??individually wrapped for single use
Documentation: Product Insert, Procedure Card
Performance Data
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
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
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
Our Precision DX Superior Drug Test Cups stand alone with USA Made Strips & Reagents as the most accurate drug test cups in the market place. Use our Precision cups for your drug test needs whether its workplace, clinical, or probation, and have peace of mind because your results are 99% accurate.
Tests for THC/COC/AMP/OPI/mAMP/PCP/BAR/BZO/MTD/MDMA/OXY/BUP+PH/SG/CREA
Pallet Size: 48x40x72
Pallet Weight: 504lbs
Shelf Life is 24 Months from date of manufacture
Up to 99% Accuracy, USA Made Strips and Reagents
Instant Results, Read Negatives within 1 minute & Positives in 5 minutes
Includes Celsius/Fahrenheit temp strip
Lock lid, no leakage
Design is sturdy, durable, and plastic to maintain sample volumes for lab receiving
Choose from 40 different drugs
These are screening devices only and although very accurate if you get a non negative result and have questions we recommend you send to our certified lab for LC-MS/MS Confirmation.
