Hymon Sars-CoV-2 One-step RT-PCR test kit ($16.00/unit)
Hymon Sars-CoV-2 One-step RT-PCR test kit ($16.00/unit)
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Hymon Sars-CoV-2 One-step RT-PCR test kit ($16.00/unit)

Regular price
$1,536.00
Sale price
$1,536.00
Regular price
$1,728.00
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Unit price
per 

Intended Use

The Hymon SARS-CoV-2 Test Kit is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in upper respiratory specimens (such as nasal, mid-turbinate, nasopharyngeal, and oropharyngeal swab specimens) and bronchoalveolar lavage specimens from individuals suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, 42 U.S.C. §263a, to perform high complexity tests.

 Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infective status. Positive results do not rule out bacterial co-infection with other viruses. Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.

 Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.

 The Hymon SARS-CoV-2 Test Kit is intended for use by qualified clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR assays and in vitro diagnostic procedures. The Hymon SARS-CoV-2 Test Kit is only for use under the Food and Drug Administration’s Emergency Use Authorization.

Kit contents

 

Item

Size

Amount

Contents

Sample reagents

LY Buffer Solution

500 μL

1 tube

Tris

PN Buffer Solution

50 μL

1 tube

Lysozyme

Nucleic acid detection reagents

PM Buffer

(PCR reaction solution)

1.3 mL

1 tube

Primers & probes, dNTPs, MgCl2

RE Mix

(Reverse transcriptase mixture)

100 μL

1 tube

Reverse transcriptase, Taq DNA polymerase

Controls

PC

(Positive control)

 

25 μL

1 tube

Synthetic RNA

NC

(Negative control)

900 μL

1 tube

H2O

          

Quantity per box:

96 Tests per box