PCR Test

200 copy /mL Higher Sensitivity, High Stability, simultaneous detection of ORFIab, N target genes, and internal control gene

High sensitivity: Compared with competing products A (sensitivity is 500 copy/mL) and B (sensitivity is 1000 copy/mL) , Zeesan SARS-CoV-2 Test Kit (Real-time PCR) has a very high sensitivity of up to 200 copy/mL.

High stability: Zeesan SARS-CoV-2 Test Kit (Real-time PCR) can be stored in the dark at 2-8 C for 6 months. It is recommended to transport at -18 C —37 C .

Less false negatives: Zeesan SARS-CoV-2 Test Kit (Real-time PCR) simultaneous tests ORFlab and N genes according to the CDC recommendation. Internal control gene is also tested to prevent false negatives.

1. Intended Use

The SARS-CoV-2 Test Kit (Real-time PCR) is an in vitro diagnostic real-time reverse transcription-PCR intended for thee qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal/oropharyngeal swabs, anterior/mid-turbinate nasal swabs, nasopharyngeal washes/aspirates or nasal aspirates, and bronchoalveolar lavage (BAL) specimens from individuals suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. S263a, that meets requirements to perform high complexity tests.

Results are for the identification of SARS-CoV-2 RNA which is generally detected 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 infection status. positive results do not rule out bacterial infection or co-infection with other viruses. “Ille agent detected may not be the definite cause of disease. 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.

Testing with the SARS-CoV-2 Test Kit (Real-time PCR) is intended for use by qualified laboratory personnel specifically instructed and trained in the techniques Of real-time PCR and in vitro diagnostic procedures. SARS-CoV-2 Test Kit (Real-time PCR) is only for use under the Food and Drug Administration’s Emergency Use Authorization.

2. Summary And Explanation

The SARS-CoV-2 Test Kit (Real-time PCR) is a molecular in vitro diagnostic test that uses Taqman probe-based technology for the qualitative detectionn of SARS-CoV-2. product contains oligonucleotide primers, labeled oligonucleotide probes, and control material used in real-time RT-PCR for the in vitro qualitative detection of SARS-CoV-2 RN A extracted from respiratory specimens.

3. PRINCIPLE OF PROCEDURES

The SARS-CoV-2 Test Kit (Real-time PCR) is a multiplex, Taqman probe-based one-step reverse transcription-polymerase chain reaction (RT-PCR), which enables simultaneous qualitative detection Of ORF lab and a region of the N gene that are specific for SARS-COV-2 as well as a non-human internal control (Armored RNA for SUC2) in one reaction. For ease Of storage and transportation, the amplification reagent is designed as a pre-distributed dry reagent (lyophilized).

4. REAGENTS AND MATERIALS SUPPLIED

The SARS-CoV-2 Test Kit (Real-time PCR) contains reagents for 48 tests, components are tabulated below.

Note: Do not interchange reagents from one kit lot to another.

5. INSTRUMENT

The SARS-CoV-2 Test Kit (Real-time PCR) was validated for use with the Applied BiosystemsTm QuantStudio 3 real-time PCR thermal cycler with QuantStudioTm Design & Analysis Software v1.4.3 that contains FM!. IIE.V.I0E. and ROX detection channels.

6. MATERIALS REQUIRED RUT NOT PROVIDED

7. STORAGE AND EXPIRATION DATE

The SARS-CoV-2 Test Kit (Real-time PCR) sould be stored at 2~8 °C away front light. The kit is temporarily valid for 12 months.
It is recommended to transport between -18 °C to 37 °C. The production date and expiration date are shown on the package label.
Do not use reagents past their expiration date.

8. WARNING AND PRECALCULATIONS

  1. For in vitro diagnostic use (1VD) only.
  2. For Emergency Use Authorization only.
  3. For Prescription Use only.
  4. The SARS-CoV-2 Test Kit (Real-time PCR) has not been FDA cleared or approved.
  5. The SARS-CoV-2 Test Kit (Real-time PCR) has been authorized by FDA under an Emergency Use Authorization (WA) for use by laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988. 42 U.S.C. §263a. that meet requirements to perform high complexity tests.
  6. The SARS-CoV-2 Test Kit (Real-time PCR) has been authorized only for the detection of nucleic acid from SARS-CoV-2. not for any other viruses or pathogens.
  7. The SARS-CoV-2 Test Kit (Real-time PCR) is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for the detection and or diagnosis of COV1D-19 under Section 564(b)( I) of the Federal Food, Drug. and Cosmetic Act. 21 U.S.C. § 3601166-3(bX1). unless the authorization is terminated or revoked sooner.
  8. Operators must be trained and have a certain experience. Please read the instructions carefully before using the kit.
  9. Follow standard precautions. All patient specimens and positive controls should be considered potentially infectious and handled accordingly.
  10. Do not eat, drink, smoke, apply cosmetics or handle contact lenses in areas where reagents and human specimens are handled.
  11. Handle all specimens as if infectious using safe laboratory procedures. Refer to Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with 2019-nCoV https://www.cdc.gov/coronavirus/2019-nCoV/Iab-biosafety-guidelines.html. Dispose of hazardous or biologically contaminated materials according to the practices of your institution.
  12. Please conduct the test operation in strict accordance with the management standards of gene amplification test laboratory: for example, the PCR test shall be strictly divided into different sections; There should be special gloves and pipettes in each district, and they should not be cross-used to avoid contamination; Operators should follow the principle of one-direction from zone one to zone two, and each working area is relatively isolated; The work table and related items for PCR test should be sterilized and disinfected regularly with 1% sodium hypochlorite, 75% alcohol, or 1 mol/L hydrochloric acid (for used pipette tips) or ultraviolet lamp.
  13. Consumable items for test operation shall be used in one time and treated aseptically before use.
  14. The controls in the kit should be fully thawed before use, well mixed, and briefly centrifuged. Bubbles should be avoided. The PCR reaction tube should be centrifuged instantaneously after adding the template. Avoid shaking the PCR reaction tube before starting the machine and in order to avoid contaminations, pay careful attention to the capped tubes and make sure each tube is sealed tightly.
  15. The PCR reaction mixture should be kept away from light; negative control and positive control should be run for each test.
  16. Do not mix reagents of different batches. Please use the kit within the validity period.
  17. After the reaction, remove the PCR tubes (closed) and put them into a self-sealing (zip) bag and seal tightly, treat as a biohazardous source.
  18. Results should be interpreted by a trained professional in conjunction with the patient’s history and clinical signs and symptoms, and epidemiological risk factors. False-positive and false-negative results can be caused by poor specimen quality, improper sample collection, improper transportation, improper laboratory processing, or a limitation of the testing technology. The operator should understand the principles of the procedures, including its performance limitations, in advance of operation to avoid potential mistakes.
  19. Negative results do not preclude infection with the SARS-CoV-2 virus and should not be the sole basis of a patient treatment:management or public health decision. Follow up testing should be performed according to the current CDC recommendations.

9. SAMPLE REQUIREMENTS

Specimen types:

  • Upper respiratory tract specimens: nasopharyngeal swabs, oropharyngeal swabs, anterior nasal and mid-turbinate nasal swabs, nasopharyngeal washes/aspirates, or nasal aspirates.
  • Lower respiratory tract specimens: bronchoalveolar lavage (BALs).

For the extraction method of different specimen types, please refer to “Specimen Extraction and Loading” in the test procedure.
Inadequate or inappropriate specimen collection, storage, and transport are likely to yield false test results. Training in specimen collection is highly recommended due to the importance of specimen quality.

Sample collection: Collect nasopharyngeal swabs, oropharyngeal swabs, anterior nasal and mid-turbinate nasal swabs. nasopharyngeal washes/aspirates or nasal aspirates, or bronchoalveolar lavage (BAL) specimens from individuals suspected of having COVID-19 by their healthcare provider. Flocked swabs with plastic shafts in viral transport media/universal transport media are acceptable for processing with the workflow of the SARS-CoV-2 Test Kit (Real-time PCR). Sterile, DNase/RNase free containers without preservatives should be used for collection of BALs/washes/aspirates. Specimen collection should avoid possible contamination during collection, storage, and transportation. The specimen should be presumed contagious and be handled according to related regulations.

Sample storage: Samples collected in common viral transport medium (swabs) or DNase/RNase free containers without preservative (BALs/washes/aspirates) should be submitted timely for testing. If necessary, specimens can be stored at 4 et for up to 72 hours if shipping or extraction cannot proceed immediately upon collection/sample receipt. If a delay in processing is expected to exceed 72 hours, then store specimens at -70°C or lower.

Sample transportation: Specimens must be packaged and shipped in accordance with the current edition of the International Air Transport Association (LATA) Dangerous Goods Regulations and Guidance of the Centers for Disease Control and Prevention (CDC).

6. MATERIALS REQUIRED RUT NOT PROVIDED

The SARS-CoV-2 Test Kit (Real-time PCR) is an in v