We have the ability to supply both POC as well as OTC kits. POC kits start at $4.25 per test. OTC kits start at $6.75 per test.
All Test Kits are OTG in the US at the Celltrion Warehouse. Delivery is available for a minimal fee, or no fee at all depending on the order. The Test Kits are either picked up at the Celltrion warehouse in TN or NJ or drop shipped to your facility.
For large Bulk orders with weekly or monthly allocation, a 10% deposit is required to reserve the specific allocation, and the balance is paid prior to pickup or delivery.
Both the POC and OTC Test Kits are available for delivery also in large quantities, however due to the high demand, a pick up schedule or delivery schedule will be determined at the moment the PO is issued and will become an integral part of the supply agreement.
Clinitest OTC covid test kits (by Siemens) - FDA approved for use in the USA - Capacity to supply 5M per week - 50% payment up front, then the remaining 50% after the airway bill and packing slip are provided
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.
We have FDA approved Antigen Home test kits with CE and more certifications.
FOB China will be from $4 USD/test. Can supply up to 1 million every fortnight, Quantities can be extended. For real buyers, we must arrange a personal meeting in USA, China, New Zealand, Australia and Europe with our local offices.
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We have FDA approved Antigen Home test kits with CE and more certifications.
FOB China will be from $4 USD/test. Can supply up to 1 million every fortnight, Quantities can be extended. For real buyers, we must arrange a personal meeting in USA, China, New Zealand, Australia and Europe with our local offices.
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
[Intended Usage]
This kit is used for the in vitro qualitative detection of suspected cases of pneumonia caused by New Coronavirus infection, patients with suspected clusters, other patients who need to be diagnosed or differentially diagnosed with the New Coronavirus infection, and nasopharyngeal swabs, oropharyngeal swabs, and bronchoalveolar lavage fluid samples of patients with mutation beads for the New Coronavirus ORF1ab and N gene, S gene N501Y mutation and S gene E484K mutation sites.
[Storage Conditions & Validity]
1. The kit should be stored frozen at -20 and protected from light; the expiration date is 6 months; the production date and expiration date are shown in the outer packaging box.
2. Avoid repeated freezing and thawing of the kit and the number of freezing and thawing shall not exceed 7 times.
3. After opening, the bottles should be stored at -20 and protected from light. The number of bottles opening times should not exceed 7 times, which will not affect the use within the validity period.
[Applicable Instruments]
1. This kit has been validated on ABI7500 quantitative fluorescence PCR instrument.
2. For other models not listed, relevant experiments have not been performed or completed for this kit. If users need to use this type of instrument platform to carry out the detection of this reagent, please contact our Technical Department at for relevant support.
NB: The other devices can include quantitative fluorescence PCR platforms with FAM, VIC, ROX and Cy5 channels.
[Sample Requirements]
1. Nasopharyngeal swabs, oropharyngeal swabs and other methods are used to obtain samples, and it is recommended to use commercial virus sampling kits for sample collection devices.
[Test Results Interpretation]
1. Negative and positive controls should be tested in each experiment and the test result can be determined only when the controls meet the quality control requirements.
2. When FAM, VIC and ROX channels are positive, Cy5 channel result may be negative due to the system competition.
3. When the internal standard result is negative, if the FAM, VIC and ROX signals of the test sample are also negative, the test result of the sample is invalid, and the cause should be found and eliminated, and the experiment repeated for this sample.
[Product Performance Index]
1. Precision: The coefficient of variation Intra-batch / Inter-batch, Intra-day / Inter-day among different operators shall not be higher than 5.0%.
2. Coincidence rate of negative positive controls: The coincidence rate of positive controls and negative controls is 100%.
3. Minimum detection limit: The minimum detection limit of this kit is 500 copies/mL.
INTENDED USE
For qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in serum, plasma (EDTA, sodium citrate and lithium heparin) or fingerstick whole blood, venous whole blood specimens from patients suspected of COVID-19 infection.
FEATURES
Coated with carefully selected specific Nucleocapsid and Spike protein antigen.
Detection for IgM and IgG antibodies simultaneously.
Simple operation, easy result interpreted.
Rapid test within 15 minutes.
RESULTS INTERPRETATION
Positive:
1. The presence of 3 red lines (T1, T2 and C) within the reaction window, no matter which band appears first, indicates presence of both SARS-CoV-2 IgM and IgG antibodies.
2. The presence of 2 red lines (T1 and C) within the reaction window, no matter which band appears first, indicates presence of SARS-CoV-2 IgM antibody.
3. The presence of 2 red lines (T2 and C) within the reaction window, no matter which band appears first, indicates presence of SARS-CoV-2 IgG antibody.
Negative:
1. The presence of line (control line) only within the reaction window indicates that no SARS-CoV-2 antibodies are detected. The results is negative.
Invalid:
1. If the control(C) line is not displayed in 10-15 min, regardless of whether T1 and/or T2 line is present, the test result is invalid. It is recommended that the specimen should be re-tested.
2. The test result is invalid after 15 min.
Our covid-19 antigen saliva test and covid 19 ag swab test already got Germany BFARM number and passed PEI test, and antigen nasal test has been registered on EU common list, hope to cooerate with your esteemed company, self testing is on progress. Hope to cooperate with your esteemed company, and we got very good feedback from many clients, promise you high quality.
The COVID-19 RT-PCRT est is a real-time reverse transcription polymerase chain reaction (rRT -PCR) test. The test can be run in a singleplex format (three individual assays) or multiplexed into a single reaction and amplification set up.
